[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


    EXAMINING IMPROVEMENTS TO THE REGULATION OF MEDICAL TECHNOLOGIES

=======================================================================

                                HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             FIRST SESSION

                               __________

                              MAY 2, 2017

                               __________

                           Serial No. 115-28
                           
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]                           


      Printed for the use of the Committee on Energy and Commerce

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                    COMMITTEE ON ENERGY AND COMMERCE

                          GREG WALDEN, Oregon
                                 Chairman
JOE BARTON, Texas                    FRANK PALLONE, Jr., New Jersey
  Vice Chairman                        Ranking Member
FRED UPTON, Michigan                 BOBBY L. RUSH, Illinois
JOHN SHIMKUS, Illinois               ANNA G. ESHOO, California
TIM MURPHY, Pennsylvania             ELIOT L. ENGEL, New York
MICHAEL C. BURGESS, Texas            GENE GREEN, Texas
MARSHA BLACKBURN, Tennessee          DIANA DeGETTE, Colorado
STEVE SCALISE, Louisiana             MICHAEL F. DOYLE, Pennsylvania
ROBERT E. LATTA, Ohio                JANICE D. SCHAKOWSKY, Illinois
CATHY McMORRIS RODGERS, Washington   G.K. BUTTERFIELD, North Carolina
GREGG HARPER, Mississippi            DORIS O. MATSUI, California
LEONARD LANCE, New Jersey            KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky              JOHN P. SARBANES, Maryland
PETE OLSON, Texas                    JERRY McNERNEY, California
DAVID B. McKINLEY, West Virginia     PETER WELCH, Vermont
ADAM KINZINGER, Illinois             BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         PAUL TONKO, New York
GUS M. BILIRAKIS, Florida            YVETTE D. CLARKE, New York
BILL JOHNSON, Ohio                   DAVID LOEBSACK, Iowa
BILLY LONG, Missouri                 KURT SCHRADER, Oregon
LARRY BUCSHON, Indiana               JOSEPH P. KENNEDY, III, 
BILL FLORES, Texas                       Massachusetts
SUSAN W. BROOKS, Indiana             TONY CARDENAS, California
MARKWAYNE MULLIN, Oklahoma           RAUL RUIZ, California
RICHARD HUDSON, North Carolina       SCOTT H. PETERS, California
CHRIS COLLINS, New York              DEBBIE DINGELL, Michigan
KEVIN CRAMER, North Dakota
TIM WALBERG, Michigan
MIMI WALTERS, California
RYAN A. COSTELLO, Pennsylvania
EARL L. ``BUDDY'' CARTER, Georgia
                         Subcommittee on Health


                       MICHAEL C. BURGESS, Texas
                                 Chairman
BRETT GUTHRIE, Kentucky              GENE GREEN, Texas
  Vice Chairman                        Ranking Member
JOE BARTON, Texas                    ELIOT L. ENGEL, New York
FRED UPTON, Michigan                 JANICE D. SCHAKOWSKY, Illinois
JOHN SHIMKUS, Illinois               G.K. BUTTERFIELD, North Carolina
TIM MURPHY, Pennsylvania             DORIS O. MATSUI, California
MARSHA BLACKBURN, Tennessee          KATHY CASTOR, Florida
CATHY McMORRIS RODGERS, Washington   JOHN P. SARBANES, Maryland
LEONARD LANCE, New Jersey            BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia         KURT SCHRADER, Oregon
GUS M. BILIRAKIS, Florida            JOSEPH P. KENNEDY, III, 
BILLY LONG, Missouri                     Massachusetts
LARRY BUCSHON, Indiana               TONY CARDENAS, California
SUSAN W. BROOKS, Indiana             ANNA G. ESHOO, California
MARKWAYNE MULLIN, Oklahoma           DIANA DeGETTE, Colorado
RICHARD HUDSON, North Carolina       FRANK PALLONE, Jr., New Jersey (ex 
CHRIS COLLINS, New York                  officio)
EARL L. ``BUDDY'' CARTER, Georgia
GREG WALDEN, Oregon (ex officio)
  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, opening statement..............................     1
    Prepared statement...........................................     2
Hon. Gene Green, a Representative in Congress from the State of 
  Texas, opening statement.......................................     4
Hon. Greg Walden, a Representative in Congress from the State of 
  Oregon, opening statement......................................     5
    Prepared statement...........................................     6
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     8
    Prepared statement...........................................     8

                               Witnesses

Jeffrey Shuren, M.D., J.D., Director, Center for Devices and 
  Radiological Health, Food and Drug Administration..............    10
    Prepared statement...........................................    11
Thomas Powers, Ph.D., Powers Consulting, LLC.....................    36
    Prepared statement...........................................    38
Frank Lin, M.D., Ph.D., Associate Professor of Otolaryngology, 
  Head and Neck Surgery, Geriatric Medicine, Mental Health, and 
  Epidemiology, Johns Hopkins University.........................    52
    Prepared statement...........................................    54
Joe Robinson, Senior Vice President, Health Systems Solutions, 
  Philips North America..........................................    61
    Prepared statement...........................................    63
Robert Kerwin, General Counsel, International Association of 
  Medical Equipment Remarketers and Servicers....................   128
    Prepared statement...........................................   130
Patricia Shrader, Vice President, Global Regulatory Affairs, 
  Medtronic......................................................   140
    Prepared statement...........................................   142

                           Submitted Material

Statement of Senators Warren, Grassley, Hassan, Isakson, 
  submitted by Mrs. Blackburn....................................   161
Statement of Consumer Technology Association, submitted by Mrs. 
  Blackburn......................................................   162
Statement of AARP, submitted by Mr. Kennedy......................   164
Statement of the Academy of Doctors of Audiology, submitted by 
  Mr. Kennedy....................................................   165
Statement of the National Committee to Preserve Social Security & 
  Medicaid, submitted by Mr. Kennedy.............................   167
Statement of Consumers Union, April 17, 2017, submitted by Mr. 
  Kennedy........................................................   168
Statement of Hearing Loss Association of America, submitted by 
  Mr. Kennedy....................................................   170
Statement of Bose Corporation, submitted by Mr. Kennedy..........   172
Statement of TriMedx, submitted by Mr. Kennedy...................   173
Article entitled, ``No more suffering in silence?,'' Consumer 
  Reports, March 2017, submitted by Mr. Burgess..................   179
Statement of the International Hearing Society, submitted by Mr. 
  Burgess........................................................   185
Statement of the American Speech-Language-Hearing Association, 
  submitted by Mr. Burgess.......................................   190
Statement of the Academy of Doctors of Audiology, submitted by 
  Mr. Burgess....................................................   192
Statement of the American Academy of Otolaryngology--Head, and 
  Neck Surgery, submitted by Mr. Burgess.........................   201
Statement of the Consumer Technology Association, submitted by 
  Mr. Burgess....................................................   204
Statement of Consumers Union, May 1, 2017, submitted by Mr. 
  Burgess........................................................   206
Statement of Repair.org, submitted by Mr. Burgess................   210
Statement of the Association of Medical Device Service 
  Organizations, submitted by Mr. Burgess........................   213
Statement of Mobile Instrument Service & Repair, submitted by Mr. 
  Burgess........................................................   215

 
    EXAMINING IMPROVEMENTS TO THE REGULATION OF MEDICAL TECHNOLOGIES

                              ----------                              


                          TUESDAY, MAY 2, 2017

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:03 a.m., in 
room 2123, Rayburn House Office Building, Hon. Michael Burgess, 
M.D. (chairman of the subcommittee) presiding.
    Present: Representatives Burgess, Guthrie, Barton, Upton, 
Shimkus, Blackburn, Lance, Griffith, Bilirakis, Long, Bucshon, 
Brooks, Mullin, Hudson, Collins, Carter, Walden (ex officio), 
Green, Engel, Schakowsky, Butterfield, Castor, Sarbanes, 
Schrader, Kennedy, Eshoo, and Pallone (ex officio).
    Also Present: Representatives Dingell and Costello.
    Staff Present: Ray Baum, Staff Director; Zachary Dareshori, 
Staff Assistant; Daryll Dykes, Health Fellow; Paul Edattel, 
Chief Counsel, Health; Jay Gulshen, Legislative Clerk, Health; 
Katie McKeough, Press Assistant; Carly McWilliams, Professional 
Staff Member, Health; Alex Miller, Video Production Aide and 
Press Assistant; Danielle Steele, Policy Coordinator, Health; 
John Stone, Senior Counsel, Health; Jeff Carroll, Minority 
Staff Director; Samantha Satchell, Minority Policy Analyst; 
Kimberlee Trzeciak, Minority Senior Health Policy Advisor; and 
C.J. Young, Minority Press Secretary.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE 
              IN CONGRESS FROM THE STATE OF TEXAS

    Mr. Burgess. The Subcommittee on Health will now come to 
order. The chair recognizes himself for 5 minutes for the 
purposes of an opening statement.
    Today's hearing is another step in the subcommittee's work 
to reauthorize the Food and Drug Administration's user fee 
agreements with industry. This subcommittee has held three 
hearings on the user fee program, during which time members 
have examined proposed agreements for generic drugs, biosimilar 
products, branded drugs, and medical devices.
    Last month, bipartisan leaders of the Senate and House 
Committees on Health released a discussion draft to reauthorize 
those agreements. Today, we will consider several bipartisan 
bills intended to further improve the regulation of medical 
technologies. This is one of my top priorities, is to build 
upon this committee's work in the 21st Century Cures Act to get 
safe and effective treatments to patients and providers without 
unnecessary delay. H.R. 1652, the Over-the-Counter Hearing Aid 
Act of 2017, would implement recommendations from the 
President's Council of Advisors on Science and Technology and 
the National Academies of Sciences, Engineering, and Medicine.
    Specifically, H.R. 1652 would direct the Food and Drug 
Administration to promulgate regulations establishing a 
category for over-the-counter hearing aids. This category of 
over-the-counter hearing aids would be limited to use by adults 
with mild to moderate hearing loss. Representatives Blackburn, 
Kennedy, and Carter introduced this bill to safely increase 
access and affordability in the hearing aid market for millions 
of Americans from whom it would benefit.
    Representatives Costello and Peters introduced H.R. 2009, 
the Fostering Innovation and Medical Imaging Act of 2017. This 
bill seeks to improve the regulation and the oversight of 
medical imaging devices intended for or used in conjunction 
with contrast agents.
    H.R. 2009 takes targeted steps to reduce excessive 
regulatory burdens so that patients and physicians have access 
to a robust market of medical imaging technologies.
    H.R. 2118, the Medical Device Servicing Safety and 
Accountability Act, also introduced by Representatives Costello 
and Peters, would require all medical device servicers to 
register with the Food and Drug Administration and maintain a 
compliant handling system.
    Currently, only original equipment manufacturers are 
required to register and report. This bill seeks to increase 
visibility and accountability for all parties servicing medical 
devices in order to ensure that devices that are used for 
patient care continue to perform safely and effectively.
    Representatives Bucshon, Peters, Brooks, and Butterfield 
introduced the fourth bill we will consider today, H.R. 1736. 
This bill would modernize the Food and Drug Administration's 
device inspections to increase its consistency and 
transparency. More specifically, H.R. 1736 would establish 
risk-based inspections, the schedule for device facilities, 
standardized inspection processes, and increased transparency 
around FDA determinations related to inspections.
    Each of these bills we will examine today is intended to 
increase innovation and increase access to medical devices and 
technology by making certain that the regulatory environment is 
consistent, effective, and agile, ensuring that patients and 
providers continue to benefit from safe and innovative medical 
technology.
    This is a shared priority in our work to reauthorize the 
Food and Drug Administration user fee programs. I will thank 
all of our witnesses in advance for being here. I look forward 
to hearing from each of you about how these proposals might 
improve our ability to meet this goal.
    [The prepared statement of Mr. Burgess follows:]

             Prepared statement of Hon. Michael C. Burgess

    The Subcommittee will come to order.
    The Chair will recognize himself for an opening statement.
    Today's hearing is another step in this subcommittee's work 
to reauthorize the Food and Drug Administrations' user fee 
agreements with industry. The subcommittee has held three 
hearings on the user fee program, during which time members 
examined proposed agreements for generic drugs, biosimilar 
products, branded drugs, and medical devices. Last month, 
bipartisan leaders of the Senate and House committees on health 
released a discussion draft to reauthorize those agreements. 
Today we will consider several bipartisan bills intended to 
further improve the regulation of medical technologies. It is 
my top priority to build upon this committee's work in the 21st 
Century Cures Act to get safe and effective treatments to 
patients and providers without unnecessary delay.
    H.R. 1652, the Over-the-Counter Hearing Aid Act of 2017, 
would implement recommendations from the President's Council of 
Advisors on Science and Technology, and the National Academies 
of Science Engineering and Medicine. Specifically, H.R. 1652 
would direct FDA to promulgate regulations establishing a 
category for over-the-counter hearing aids. This category of 
OTC hearing aids would be limited to use by adults with mild to 
moderate hearing loss. Representatives Kennedy, Blackburn, and 
Carter introduced this bill to safely increase access and 
affordability in the hearing aid market for the millions of 
Americans that could benefit from it.
    Representatives Costello and Peters introduced H.R. 2009, 
the Fostering Innovation in Medical Imaging Act of 2017. This 
bill seeks to improve the regulation and oversight of medical 
imaging devices intended for used in conjunction with contrast 
agents. H.R. 2009 takes targeted steps to reduce excessive 
regulatory burdens so that patients and physicians have access 
to a robust market of medical imaging technologies.
    H.R. 2118, the Medical Device Servicing and Accountability 
Act, also introduced by Representatives Costello and Peters, 
would require all medical device servicers to register with the 
FDA and maintain a complaint handling system-currently, only 
original equipment manufacturers are required to register and 
report. This bill seeks to increase visibility and 
accountability for all parties servicing medical devices in 
order to ensure that devices used for patient care continue to 
perform safely and effectively.
    Representatives Bucshon, Peters, Brooks, and Butterfield 
introduced the fourth bill we will consider today, H.R. 1736. 
This bill would modernize FDA's device inspections process to 
increase its consistency and transparency. More specifically, 
H.R. 1736 would establish a risk-based inspections schedule for 
device facilities, standardize inspection processes, and 
increase transparency around FDA determinations related to 
inspections.
    Each of the bills we will examine today is intended to 
increase innovation and access to medical devices and 
technology by making certain that the regulatory environment is 
consistent, effective, and agile.
    Ensuring that patients and providers continue to benefit 
from safe and innovative medical technology is a shared 
priority in our work to reauthorize the FDA user fee programs. 
I thank all of our witnesses for being here, and I look forward 
to hearing from each of you about how these proposals might 
improve our ability to meet this goal.

    Mr. Burgess. I would like to yield my remaining time to Dr. 
Bucshon from Indiana for his opening statement.
    Mr. Bucshon. Thank you, Mr. Chairman.
    H.R. 1736 seeks to improve the inspections process for 
medical technology manufacturers. The legislation achieves this 
goal by applying a risk-based approach to the frequency and 
nature of device establishment inspections resulting in a 
reduction of the burden on establishments with a strong history 
of compliance and by allowing the FDA to focus its resources 
where they are needed most.
    H.R. 1736 also enhances the communication between the FDA 
and manufacturers to provide more certainty and stability for 
device establishments. I would like to thank Mrs. Brooks, Mr. 
Butterfield, Mr. Peters, for their leadership on this 
legislation.
    I look forward to working with you, Dr. Shuren, as we move 
the legislation forward.
    I yield back the balance of my time.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair now recognizes the ranking member of the 
subcommittee, Mr. Green of Texas, 5 minutes for an opening 
statement, please.

   OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN 
                CONGRESS FROM THE STATE OF TEXAS

    Mr. Green. Thank you, Mr. Chairman.
    Thank you to our witnesses for being here today.
    Today, we are examining legislative proposals to improve 
the regulation of medical technologies. Many of these ideas 
follow up on the work we did in 21st Century Cures Act and 
build on negotiated agreements between the FDA and stakeholders 
to reauthorize the medical device user fee agreement.
    I want to thank the bill sponsors, the FDA, and the broader 
stakeholder community for their efforts to improve the 
innovation pipeline and ultimately giving patients access to 
technologies and therapies that can improve their lives.
    One of the bills we are considering, H.R. 1652, the Over-
the-Counter Hearing Aid Act, establishes a category for over-
the-counter, or OTC, hearing aids. Approximately 30 million 
Americans have hearing loss, and that number will only get 
bigger as the baby boomer population ages. Despite being a 
common problem that has significantly hampered quality of life 
if left untreated, only 15 to 30 percent of the people who 
benefit from assistive hearings technologies actually use them. 
There are several reasons for low adoption rates, but one of 
the main barriers is cost. The legislation builds on a 
recommendation made by the President's Council of Advisors in 
Science and Technology in 2015 and the National Academies of 
Sciences, Engineering, and Medicine in 2016 to allow for safe 
and effective OTC hearing aids to be developed.
    The goal is to find an easier, less costly way to address 
hearing loss while providing for standards in products and FDA 
oversight to ensure safety. I look forward to hearing more 
about this important legislation.
    We are also considering H.R. 1736, which would improve the 
process of FDA inspections of medical device establishments and 
for granting export certificates to foreign countries. The FDA 
is responsible for inspecting medical devices and medical 
device establishment to ensure consumer safety. Under current 
law, registered establishments of moderate- or high-risk 
devices are to be inspected every 2 years, though real-world 
feasibility of this has created discrepancies in the inspection 
process across the sector, which can be disruptive and don't 
necessarily advance patient safety. This bill models off of 
improvements we have made in inspections of drug facilities. It 
will help ensure the FDA is able to use its resources to 
protect patient safety while giving industry additional 
certainty and predictability and reduce preventable disruptions 
in the daily workflow.
    We are also H.R. 2009, the Fostering Innovation in Medical 
Imaging Act. Contrast agents complement innovations in 
diagnostic imaging. They must be improved by FDA for specific 
use; however, due to the labeling constraints, FDA is hamstrung 
in its ability to improve the use of a contrast agent that has 
been approved for one part of the body to be used in another 
despite extremely similar parameters of use. This legislation 
would allow FDA to improve the imaging device using a contrast 
agent if the contrast agent has the same dose rate and route of 
admission, affecting the same region of the body, used in the 
same patient population as the same imaging modality as the 
initial approval without the agent having to submit a 
supplemental application.
    This challenge reminds me of what we dealt with when trying 
to improve the process in which antimicrobial susceptibility 
test can be used to update break points to test for resistance. 
I look forward to learning more about this commonsense reform.
    Finally, we are considering legislation to bring more 
oversight and patient protections to the third-party servicing 
process. Many medical devices require servicing and maintenance 
over their lifecycle. This can be done by the original 
manufacturer or a third party. While original manufactures are 
required to registered with the FDA and comply with quality 
systems regulations and avoid adverse events, third-party 
services are not. There is a growing concern that not all 
third-party providers are equally qualified and that 
alterations to the devices, high-risk products, like an MRI 
machine, are not documented and can impact safety of use. Like 
a mechanic working on your car, improper servicing can have 
safety implications.
    H.R. 2118, the Medical Device Servicing Safety and 
Accountability Act, will require third-party providers to 
register with the FDA, to maintain a complaint handling system, 
and submit severe adverse reports if they become aware of major 
malfunctions. I look forward to hearing more about this 
important legislation.
    Each of these proposals has been introduced in a bipartisan 
manner, and I hope to learn more about these worthy ideas.
    And I want to thank our witnesses, again, for being here 
this morning.
    Mr. Chairman, I yield back my time.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Oregon, Mr. Walden, 
chairman of the full committee, 5 minutes for opening 
statement, please.

  OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN 
               CONGRESS FROM THE STATE OF OREGON

    Mr. Walden. I thank the gentleman from Texas, the chairman, 
for holding this hearing and our witnesses for your testimony 
today. It is very instructive and helpful in our work.
    We meet today to once again discuss the FDA's vitally 
important user fee programs, as you all know. Throughout these 
hearings we have held examining them this year, I have 
reiterated the full committee's support for a timely 
reauthorization of these user fee agreement programs. Good news 
is we are well on our way.
    To date, the Health Subcommittee has held hearings on each 
of these proposed agreements that were initially submitted to 
Congress back in January. Since that time, we have translated 
those agreements into legislative text, and the committee 
released that with the Senate Health Committee last month, 
bipartisan, bicameral. As part of that announcement, I have 
noted we will continue discussions in the House on other member 
priorities that could strengthen this important legislation.
    So today's hearing is a great opportunity for us to learn 
more about four bipartisan medical device bills that could 
potentially be included in this effort.
    H.R. 1652, the Over-the-Counter Hearing Aid Act, introduced 
by Representatives Kennedy, Carter, and Blackburn, would 
require the FDA to issue regulations establishing a category of 
OTC hearing aids for adults with perceived mild to moderate 
hearing loss. Both the President's Council of Advisors in 
Science and Technology and the National Academies have called 
for this approach. I understand that some patient safety 
concerns have been raised, and I appreciate the testimony of 
the FDA and our other witnesses on this matter.
    H.R. 2118, the Medical Device Servicing Safety and 
Accountability Act, introduced by Representatives Costello and 
Peters, would require both original medical equipment 
manufacturers and third-party service providers to register 
with the FDA and submit adverse event reports.
    Now, several small businesses have raised concerns about 
the costs they would incur in registering. I am committed to 
ensuring patient safety while minimizing regulatory burden, and 
I look forward to learning more about this bill as it goes 
forward.
    Meanwhile, H.R. 2009, the Fostering Innovation in Medical 
Imaging Act, also introduced by Representatives Costello and 
Peters, would clarify FDA's regulation of imaging devices and 
contrast agents. This bill includes commonsense changes that 
would streamline the regulatory review of these important 
technologies.
    Finally, Representatives Bucshon, Brooks, Peters, and 
Butterfield have introduced H.R. 1736, which would improve 
FDA's risk-based approach for inspecting medical device 
manufacturing facilities both domestically and abroad.
    We thank all of our committee members for bringing these 
bills forward. We thank the testimony of our witnesses to help 
inform our decisions, and I look forward to discussing these 
bills further as we move this process along.
    With that, I would yield to the gentlelady from Tennessee 
the balance of my time.
    [The prepared statement of Mr. Walden follows:]

                 Prepared statement of Hon. Greg Walden

    Thank you Chairman Burgess.
    As I have previously stated and will reaffirm today, the 
Energy and Commerce Committee is fully committed to a timely 
reauthorization of FDA's vitally important user fee programs. 
The good news is that we are well on our way.
    The Health Subcommittee held hearings on each of the 
proposed agreements that were initially submitted to Congress 
in January. Since that time, we have translated those 
agreements into legislative language which the committee 
released with the Senate HELP committee several weeks ago.
    As part of that release, I noted that as the legislative 
process proceeds I look forward to continued discussions with 
my colleagues in the House on other member priorities that 
could strengthen this important legislation.
    Today's hearing is a great opportunity for us to learn more 
about four bipartisan medical device bills that could 
potentially be included.
    H.R. 1652, the Over-the-Counter Hearing Aid Act, introduced 
by Reps. Kennedy, Carter, and Blackburn would require FDA to 
issue regulations establishing a category of OTC hearing aids 
for adults with perceived mild to moderate hearing loss. Both 
the President's Council of Advisors on Science and Technology 
and the National Academies have called for this approach. I 
understand that some patient safety concerns have been raised 
and I look forward to hearing more about that from FDA and our 
witnesses on the second panel.
    H.R. 2118, the Medical Device Servicing and Accountability 
Act, introduced by Reps. Costello and Peters, would require 
both original medical equipment manufacturers and third-party 
service providers to register with the FDA and submit adverse 
event reports. Several small businesses have raised concerns 
about the costs they would incur in registering. I am committed 
to ensuring patient safety while minimizing regulatory burden 
and look forward to learning more about this bill going 
forward.
    H.R. 2009, the Fostering Innovation in Medical Imaging Act, 
also introduced by Reps. Costello and Peters would clarify 
FDA's regulation of imaging devices and contrast agents. This 
bill includes common-sense changes that would streamline the 
regulatory review of these important technologies.
    Last but not least, Reps. Buschon, Brooks, Peters, and 
Butterfield have introduced H.R. 1736, which would improve 
FDA's risk-based approach for inspecting medical device 
manufacturing facilities both domestically and abroad.
    Thank you to all of our witnesses for their testimony and I 
yield back the balance of my time.

    Mrs. Blackburn. Thank you, Mr. Chairman.
    And I want to thank you, Dr. Shuren, and all of our 
witnesses who are here today.
    And, Mr. Chairman, I thank you for the hearing and being 
able to move these bills forward. It is so nice when we can say 
we have bipartisan legislation that we are moving forward. And 
Mr. Kennedy and I are pleased to have worked on the hearing aid 
bill, as it is called, H.R. 1652, and to see it finally moving 
forward.
    I do want to say for the record that the Academy of Doctors 
of Audiology, the oldest independent national audiology 
association and the leading authoritative body in private 
practice audiology, has been a proponent of this legislation. 
It is a win-win situation for consumers, for patients, and for 
innovation. And the ADA notes that creating an FDA-regulated 
OTC hearing device market will foster competition, broaden 
consumer choice, improve affordability, and accelerate 
innovation without increasing existing risk to the public. As I 
said, this creates a win-win environment.
    Additionally, in support of H.R. 1652, the Over-the-Counter 
Hearing Aid Act of 2017, I would like to submit a letter for 
the record authored by my Senate colleagues Senators Warren, 
Grassley, Hassan, Isakson; and a letter of support by the 
Consumer Technology Association.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mrs. Blackburn. Thank you, Mr. Chairman.
    I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair now recognizes the gentleman from New Jersey, 
ranking member of the full committee, Mr. Pallone, for 5 
minutes of opening statement, please.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Mr. Chairman.
    Today we are examining additional legislation that would 
help to improve the way the Food and Drug Administration 
reviews medical device products. Medical devices have made 
enormous advances over the last few decades, and new and 
emerging technologies hold a promise to treat and cure diseases 
in ways previously not thought of. While not the subject of 
today's hearings, reauthorizing the medical device user fee 
amendments will help to ensure that FDA has the resources and 
personnel needed to continue to improve upon the medical device 
review process and to work with industry to bring devices to 
market more efficiently. And I look forward to working with my 
colleagues to have all of the user fee agreements considered 
and sent to the President hopefully early this summer.
    I understand that members are interested in exploring the 
possibility of attaching additional policy to the user fee 
agreements. This hearing provides the opportunity to learn more 
about whether these bills meet the test of being 
noncontroversial and enjoying broad bipartisan support. And 
today we will be hearing from witnesses about the following 
four bills. I think that we have pretty much covered these 
bills. So I don't want to go into the details about them 
because I think my colleagues have already done that.
    So I just wanted to say I look forward to learning more 
from Dr. Shuren as well as our stakeholders about their 
interest in the legislation before us, and I would yield the 
balance of my time or whatever time he wants to Mr. Kennedy.
    [The prepared statement of Mr. Pallone follows:]

             Prepared statement of Hon. Frank Pallone, Jr.

    Thank you, Mr. Chairman. Today we are examining additional 
legislation that will help to improve the way the Food and Drug 
Administration reviews medical device products.
    Medical devices have made enormous advances over the last 
few decades, and new and emerging technologies hold the promise 
to treat and cure diseases in ways previously not thought of. 
While not the subject of today's hearing, reauthorizing the 
Medical Device User Fee Amendments will help to ensure that FDA 
has the resources and personnel needed to continue to improve 
upon the medical device review process and to work with 
industry to bring devices to market more efficiently. I look 
forward to working with my colleagues to have all of the user 
fee agreements considered and sent to the President early this 
summer.
    I understand that Members are interested in exploring the 
possibility of attaching additional policy to the user fee 
agreements. This hearing provides the opportunity to learn more 
about whether these bills meet the test of being non-
controversial and enjoying broad bipartisan support.
    Today we will be hearing from our witnesses about the 
following four bills:
     H.R. 1652, sponsored by Representatives Kennedy, 
Blackburn, and Carter, would direct FDA to establish by 
regulation a category of over-the-counter hearings aids for 
adults with perceived mild to moderate hearing loss. This bill 
could open up access to affordable hearing aid devices for the 
more than 37 million American adults who suffer from hearing 
loss today.
     H.R. 2009, sponsored by Representative Peters and 
Costello, would clarify the FDA review process for new 
indications of contrast agents used with medical imaging 
devices.
     H.R. 2118, also sponsored by Representative Peters 
and Costello, would require third party service providers of 
medical devices to register with the FDA, maintain a complaint 
handling system, and submit adverse event reports as original 
equipment manufacturers do today.
     And finally, H.R. 1736, sponsored by 
Representatives Peters, Butterfield, Buschon, and Brooks, would 
move FDA inspections of medical device facilities to a risk-
based schedule, and would improve communication between FDA and 
industry throughout the inspection process.
    I look forward to learning more from Dr. Shuren, as well as 
our other stakeholders, about their interests in the 
legislation before us.

    Mr. Kennedy. Thank you to Mr. Pallone.
    I want to thank Chairman Walden--both of them--for 
convening this important bipartisan hearing today.
    By beginning these conversations now, we can begin to 
prepare for innovation taking place in our districts across the 
country.
    To all of the witnesses, thank you for taking the time to 
testify before our committee to help guide us as we consider 
these four bills. And I would specifically be interested in 
hearing your thoughts on our Over-the-Counter Hearing Aid Act.
    Finally, to my cosponsor, Congresswoman Blackburn, it has 
been an honor to work with you on this bill. I am looking 
forward to working with you in the months ahead. I think the 
idea of a Blackburn-Kennedy-Warren-Grassley combination is a 
winning one going forward on a whole bunch of stuff.
    So many of us here today have experienced the pain and 
frustration of loved ones beginning to lose their hearing. 
Shared experiences at large gatherings, like sporting events, 
concerts, become less enjoyable. Balance and health begin to 
decline. And even personal one-on-one conversations become 
challenging. Nearly half of Americans over 60 years old 
experience hearing loss. But a pair of hearing aids can cost 
anywhere from $4,000 to $6,000, and Medicare will not cover 
them. Too many of our neighbors, friends, colleagues, relatives 
will simply choose to suffer without relief.
    With the innovation taking place in our districts and 
increased competition among businesses, we can improve the 
quality of hearing aids and protect patients while 
simultaneously lowering costs. That is why Congresswoman 
Blackburn and I introduced this bipartisan legislation and why 
it already has the support of consumers, doctors, and industry. 
For Americans who are beginning to lose their hearing and the 
families who love them, we should pass this bill quickly.
    Thank you very much to Mr. Pallone.
    I yield back.
    Mr. Pallone. Thank you. I don't know if any of my other 
Democratic colleagues wanted time.
    If not, Mr. Chairman, I will yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    This now concludes member opening statements. The chair 
would remind members that, pursuant to committee rules, all 
members' opening statements will be made part of the record.
    And we do want to thank our witnesses for being here today, 
for taking time to testify before the subcommittee. Each 
witness will have the opportunity to give an opening statement 
followed by questions from members.
    We will have two panels of witnesses today and begin with 
Dr. Jeffrey Shuren, friend of the subcommittee, Director, 
Center for Devices and Radiological Health at the Food and Drug 
Administration. We certainly appreciate you being here again 
today, Dr. Shuren. You are now recognized for 5 minutes for an 
opening statement.

 STATEMENT OF JEFFREY SHUREN, M.D., J.D., DIRECTOR, CENTER FOR 
 DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION

    Dr. Shuren. Well, thank you. Chairman Burgess, Ranking 
Member Green, members of the committee. Thank you for having me 
here today. I am pleased to be back to discuss potential 
changes to the medical device program.
    I first want to say that I greatly appreciate your support 
for timely reauthorization of the medical device user fee 
amendments, or the MDUFA IV.
    As you are well aware, MDUFA has been reauthorized every 5 
years since Congress, including several members on this 
committee, first created the program. And as the program has 
evolved, FDA and industry have successfully negotiated 
agreements to improve patient access to medical devices and 
streamline regulatory processes. As we discussed just a few 
weeks ago, timely reauthorization of MDUFA is critical in order 
to maintain adequate staffing levels and ensure we fulfill our 
mission of protecting and promoting the public health.
    Like you, we at CDRH want patients and healthcare 
professionals to have timely access to high-quality, safe, and 
effective medical devices first in the world.
    Changes we have made at CDRH to our culture, policies, 
processes, in addition to user fee funding and direction from 
Congress through changes to Federal law, have resulted in 
reduced decision times, improved medical device pipeline, and 
innovative technologies being introduced in the U.S. earlier 
than in the past. We want to continue on this course, and we 
appreciate that additional changes to the law can further 
advance this upward trend. Therefore, I appreciate the 
opportunity to discuss the bills before us today, and I look 
forward to answering your questions.
    [The prepared statement of Dr. Shuren follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. The chair thanks the doctor for his testimony.
    And we will move into the question-and-answer portion of 
the hearing. I recognize myself 5 minutes for questions.
    And, Dr. Shuren, let me ask you: The Food and Drug 
Administration recently published guidance indicating that it 
would no longer enforce the requirement that adult patients 
provide a physician's medical evaluation or sign a waiver to 
purchase certain hearing aids. In making this announcement, the 
FDA noted that the medical evaluation requirement provided, 
``little to no meaningful benefit to patients.''
    Can you take us through the FDA's decision to no longer 
enforce this requirement that had been in place since the 
1970s?
    Dr. Shuren. Yes. There had been several studies that had 
been done looking at the FDA's requirement that there be a 
medical evaluation if not the signing of a waiver. The 
conclusions were that this was serving more as a barrier, not 
providing benefit to patients, and then this was further 
reinforced by the recent recommendations by both PCAST and the 
National Academies of Sciences, Engineering, and Medicine, who 
both recommended that we no longer enforce that requirement.
    Mr. Burgess. So, to the extent that it was an impediment, 
has it impacted consumer access to hearing aids over the years?
    Dr. Shuren. That is our understanding from both consumers 
who have been asked about it as well as other experts in the 
field.
    Mr. Burgess. And so the FDA's position currently aligns 
with recommendations put forth by the President's Council of 
Advisors on Science and Technology and the National Academies 
of Sciences, Engineering, and Medicine?
    Dr. Shuren. Yes.
    Mr. Burgess. So Dr. Lin will testify on the second panel 
that there is absolutely no medical reason or rationale to 
consider limiting the intended use of over-the-counter hearing 
aids to only those individuals with a mild hearing loss. Do you 
agree?
    Dr. Shuren. Yes.
    Mr. Burgess. What, then, would be the implications of 
broadening that so that it included the mild and moderate 
designations in that category?
    Dr. Shuren. Well, so, if there is an over-the-counter 
hearing aid category, it makes sense, then, it should apply to 
mild- and moderate-risk consumers, that the appropriate limits, 
let's say in output and labeling, could be put on those 
technologies for appropriate use by consumers. Limiting it to 
just patients with mild hearing loss, may deny access for other 
patients who could benefit from hearing aids who otherwise 
won't be getting it.
    You have to remember: Today, we have over 30 million 
Americans who may be suffering from hearing loss, but only 
around 20 percent actually go and get hearing aids. So most 
people don't even bother to get it. We have to find better ways 
to provide better access and better competition in the 
marketplace through technology.
    Mr. Burgess. And then how could we address the concern--
like children are a special category with hearing aids, having 
had a family member who went through this many, many years ago. 
What are the protections, then, that would exist for--what 
would prevent a parent from just purchasing a hearing aid 
without an evaluation for a child?
    Dr. Shuren. Well, we are still maintaining the requirement 
in place that there is medical evaluation, the signing at least 
of a waiver, for those individuals who are under the age of 18.
    Mr. Burgess. Let me ask you: On the medical equipment 
issue, the FDA recently held a public hearing on whether and to 
what extent additional regulation of third-party service 
providers was necessary. I would ask you, first, what your 
takeaways were from that meeting and then, secondly, the 
comments that were submitted to the FDA? And if you need to 
provide those in separate testimony, that will be acceptable as 
well.
    Dr. Shuren. Certainly. Well, we received about, I think, 
176 comments to the docket. And the comments fell into two 
broad buckets. We heard from the original equipment 
manufacturers concerns about, at least in some cases, the 
quality of servicing that was provided by third parties, for 
example, some anecdotal cases where the safeguards in place in 
imaging technology to prevent overdose of radiation had been 
bypassed or cases where lower quality parts were used in the 
servicing, replacement of those parts for endoscopes.
    We also heard concerns from those manufacturers that some 
of the third-party servicers were not providing information 
about problems that were occurring. So they didn't have a good 
window of what was happening with their technology.
    On the flip side, third-party servicers were complaining 
about the fact that they had some manufacturers who weren't 
making device specifications available, and they had 
proprietary testing methods that they were not making 
available, sometimes the need for training that was not made 
available, and sometimes parts, the replacement parts, not 
being made available and, therefore, challenges for them to 
provide good servicing. But everyone agreed there is a 
critically important role for third-party servicers in our 
healthcare system.
    Mr. Burgess. So the underscore there was there was a 
critical need for the third-party servicers?
    Dr. Shuren. Yes.
    Mr. Burgess. Very good.
    I yield back the balance of my time.
    I recognize the gentleman from Texas, Mr. Green, 5 minutes 
for questions, please.
    Mr. Green. Thank you, Mr. Chairman.
    And, again, thank you for being here today, Doctor, and 
also the work that the FDA, last session, on the cures package.
    Making hearing aids available over the counter holds a 
potential to help reduce costs and thereby increasing access to 
hearing assistance that might not otherwise be available for 
certain adult patients. As the FDA and Congress moves forward 
with the creation of an overall category for over the counter 
for hearing aids, there has been discussion about the need to 
ensure that we are adequately protecting patient safety to 
prevent patients from suffering any further damage in their 
hearing.
    Dr. Shuren, last fall, the FDA announced that it is 
committed to considering creating a category of OTC hearing 
aids and noted that OTC hearing aids could deliver new and 
innovative and lower cost products to millions of consumers. 
Can you discuss the benefits of creating such a category and 
how OTC hearing aids could improve access and affordability for 
patients but also to make sure these patients on their own are 
getting the right hearing assistance?
    Dr. Shuren. So, on the one hand, as was mentioned, most 
people with hearing loss who would benefit from the hearing aid 
do not seek that out. So providing the opportunity for more 
access and affordability through competition could lead to then 
both a drive down on costs as well as better products on the 
market and easy access because they are over the counter. At 
the same time, we could see better safeguards put in place.
    In reality, there kind of is OTC products already there. 
So, for years, we have had these personal sound amplifications 
products where people with hearing loss are using them. They 
are not intended for patients with hearing loss, but they 
amplify sound, and so people are getting the wrong product for 
their needs. And there is a broad range of quality on them.
    The second is, since the regulations we put in effect in 
1977, we have allowed mail order of hearing aids--you just have 
to provide the waiver--and, since then, have allowed for 
internet access, and you can provide the waiver online as long 
as that is acceptable to the state. What we don't have, though, 
is the right information for patients out there and output 
limits for some of those technologies to appropriately tailor 
for the needs of consumers.
    So, if we went with a true OTC category, we now could have 
better product available for consumers for what they really 
need, truly hearing aids rather than these personal sound 
amplifications, and available in places like the big-box stores 
that can provide good oversight, the Walgreens of the world, 
better information for them so they know how to use it.
    And then, lastly, we are seeing a change in technology. You 
know, before you had these preprogrammed hearing aids, and you 
really needed someone to fit them. Now we are seeing 
increasingly development of self-fitting, self-programmable 
hearings aids, which now allows, then, for better tailoring by 
the patients themselves, which means that, through OTC, we 
could provide the right product in the right way.
    Mr. Green. Thank you. Thank you for your work and folks at 
the FDA last session, I want to recognize your engagement on 
the SOFTWARE Act. I think we got to a good place with that and 
deeply appreciate your input.
    One of the provisions in the part of Cures requires FDA to 
evaluate device accessories on their own merit as opposed to 
classifying them just based on sophistication of the parent 
device. As I understand it, implementing the accessories 
provision is challenging. The FDA doesn't have any tools to do 
this efficiently.
    Dr. Shuren, how is implementation of that provision 
progressing? Do you feel that you have the necessary 
authorities to carry out the accessories provision in the least 
burdensome manner both to the FDA and the companies?
    Dr. Shuren. Well, currently, we have some process 
challenges. If we are going to move an accessory that is 
currently in one classification and should appropriately be 
moved to another classification, the process is so burdensome 
that it draws away resources from our other day-to-day 
activities. So having a streamlined process could be very 
helpful to the agency. It would make us use our resources more 
wisely, and it would lead to the right reduction on unnecessary 
regulatory burden on manufacturers. None of this changes the 
scientific decisionmaking that the agency goes through to 
decide the appropriate classification.
    Mr. Green. Thank you. I think this committee should 
consider following up on our previous work and look at ways to 
make the regulation of accessories more streamlined so that the 
intent of the SOFTWARE Act that was part of Cures can be 
realized. I look forward to working with the FDA.
    And I yield back the balance of my time, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair now recognizes the gentleman from Kentucky, Mr. 
Guthrie, the vice chairman of the committee, 5 minutes for 
questions, please.
    Mr. Guthrie. Thank you, Mr. Chairman.
    Thanks, Dr. Shuren, for being here again.
    I want to pick up where Dr. Burgess left off dealing with 
the third-party medical equipment. I know you were talking 
about in the last hearing you are in data-gathering mode. You 
were talking about the different comments that you received. At 
this point, has FDA made any determination on what direction to 
go?
    Dr. Shuren. We have not. We are still talking with people, 
still gathering information.
    Mr. Guthrie. Do you have any idea as you move forward what 
the registration would be like, or what would happen in them 
moving forward, or what fees might be associated with it?
    Dr. Shuren. Right. Not at this time. I will say that, under 
current law, if you register with the FDA, then there are user 
fees that are applied, at least under current law.
    Mr. Guthrie. OK. A couple of years back we met in my office 
and discussed manufacturing of medical devices in the United 
States versus people relocating because of the regulatory 
environment. And we discussed how we can do things safely and 
effectively but also be less regulatory--or be more friendly in 
a regulatory environment while securing safety and 
effectiveness.
    And I have heard positive comments from different people 
about what is moving forward. Could you talk about what is 
happening now with FDA in trying to safeguard the public but 
also have an opportunity to be more friendly in terms of people 
remaining here and not moving jobs overseas?
    Dr. Shuren. So we have made a conscience effort over the 
past few years to make changes in our culture, our policies, 
our processes to sort of strike the right balance. What is the 
smart regulation to have in place? And when I first came to 
CDRH in 2009, by the end of that year, we had approved only 24 
novel devices. By 2016, that number was 91, and it had gone up 
every year except for one.
    In 2016, that is the most number of novel device we had 
approved since the start of the user fee program; second 
highest was the year before. And a lot of it comes to putting 
in place patient-centric benefit-risk frameworks, where we take 
into account not just the benefit-risk of the technologies but 
the benefit-risk tradeoffs of the decisions that we make. We 
have had a smart focus, I think, on the safety side, how we 
better use real-world evidence both to help technologies come 
to market but also to identify problems once they are on the 
market.
    Mr. Guthrie. Thank you. And I guess I have heard very 
positive comments from people trying to do their business here 
in the United States and hire American workers. What is FDA 
doing to address the discrepancies between inspections of 
domestic and foreign manufacturing facilities, and what about 
discrepancies across different districts in the U.S.?
    Dr. Shuren. So our field staff, which is under our Office 
of Regulatory Affairs, or ORA, is about to stand up their 
program alignment, under which they are moving from a 
geographically-based system, their inspectors, to one that is 
based on commodity. So now there will be a medical device 
program with a director and where there are inspectors who only 
inspect device facilities that are across the country, but they 
report up to the same line of management. And like I said, that 
will get unveiled in the middle of May. Well, it will probably 
take about a little over another year to finish off the 
structure. We are also going to be looking at changes in their 
processes and their policies so that there is greater 
consistency in the inspections, both domestically and foreign, 
as well as people who are better focused on, I think, device 
inspections, which means getting higher quality reviews than 
they already do today.
    Mr. Guthrie. OK. Thank you.
    I appreciate the work and the effort that you are doing.
    That completes my questions. I will yield back. If you need 
more time, Mr. Chairman?
    Mr. Burgess. The chair will be happy if the gentleman 
yields back.
    And I will recognize the gentlelady from California, Ms. 
Eshoo, for 5 minutes of questions, please.
    Ms. Eshoo. Thank you, Mr. Chairman.
    Good morning, Doctor. Nice to see you. Welcome back.
    The first comment, question I have, when I was preparing 
for today's hearing last evening, I immediately went to your 
testimony, and it is the first time I have seen testimony that 
really isn't testimony. You essentially say: ``Good morning. It 
is nice to be here. We are reauthorizing this and looking 
forward to chatting with you.'' That may not be the most 
professional description of it.
    Why--because we have I think, what, four bills before us--
isn't there any comment or examination of today's hearing?
    Dr. Shuren. So both the agency, Department of Health and 
Human Services, have been going through the legislation. We 
have been asked to provide technical assistance, and so that 
will be coming in time for review by the committee. But it has 
not finished going through clearance, and that is why you don't 
see----
    Ms. Eshoo. Clearance for what?
    Dr. Shuren. For the technical assistance. Just the usual 
process as that is reviewed and provided back to Congress.
    Ms. Eshoo. I don't quite get that. You are not supposed to 
comment on what is before us in this hearing?
    Dr. Shuren. Yes, I am commenting. I know people would 
like----
    Ms. Eshoo. But I mean in written testimony.
    Dr. Shuren. Yes, but because the technical assistance has 
not yet been finalized, that would be the substance if we were 
going into specific aspects on the testimony.
    Ms. Eshoo. Well, I don't quite get it. But at any rate, it 
is the thinnest written testimony that, I think, I have ever 
seen in a packet. But at any rate, two questions: On the over-
the-counter hearing aids, I think that the legislation moves in 
the direction that we need to go. What will protect people from 
buying the wrong thing? Just because it is over the counter 
does not make anything magical. And over the counter, does that 
connotate a savings in the mechanisms that are bought? So, 
first of all, do we know that there will be savings, A? And, B, 
what about the consumer? How do they know what is best for 
them? They know that they need help, but I think the question 
is still out there between moderate and--what is it?--moderate 
and mild? There are two categories. That is my first question.
    My second question is on inspections. In examining the 
legislation relative to both domestic and foreign inspections, 
does the legislation advance, I don't know, a level of 
thoroughness? Do we lose anything? What are we gaining? I am 
not so sure I understand what the difference is between foreign 
and domestic inspections.
    Now, you just alluded to where you want to improve. It is 
going to take all of about a year to put things together. You 
are not quite ready for prime time to come out with that.
    Does this legislation track with what you are attempting to 
do? Does it go beyond it? So those are my two questions.
    Dr. Shuren. Certainly.
    Ms. Eshoo. Questions within questions.
    Dr. Shuren. Yes. So, regarding the OTC hearing aids, you 
first have to start with the practical reality that roughly 
about 80 percent of people with hearing loss who would benefit 
from a hearing aid never go to get one in the first place. So 
they never get----
    Ms. Eshoo. So, if it is over the counter, you would 
calculate that, of the 80 percent that don't, that maybe 60 
percent of the 80 percent will?
    Dr. Shuren. I don't think anyone knows the percent----
    Ms. Eshoo. We just don't know, right.
    Dr. Shuren. What we keep hearing, even from consumers, is--
--
    Ms. Eshoo. And we want them to get help. I want them to get 
help.
    Dr. Shuren. Exactly. So that could get them in the door.
    The second is their--putting in place, are there ways in 
which consumers can better identify maybe the extent of hearing 
loss they had and what would be a better option for them.
    Ms. Eshoo. How are they to know that, though?
    Dr. Shuren. So there is going to be a meeting by the 
National Academies of Sciences, Engineering, and Medicine on 
June 9. That is going to be one of the topics of conversation. 
There is also we are seeing increasingly where some of the 
technology is building in the capability for us to assess the 
hearing capability of the individual, and that is one of the 
places where we see the marketplace going. So you have 
technology or at least opportunities through the internet for 
some assessment of the individual that may, then, help in the 
selection of the technology. And the other is, as we see more 
and more technologies that are self-programmable--so they may 
not be locked in. They can then change the setting. But that is 
not going to happen if we don't create the competitive 
marketplace for it. That is the challenge that we face.
    Ms. Eshoo. And inspections?
    Dr. Shuren. And then regarding inspections, so for the 
thoroughness of foreign and domestic, both of them are thorough 
inspections. We spend the time we need to do. I think the 
challenge people have raised is, why is it that foreign 
inspections may take less time than domestic? And in part, that 
is when we send our inspectors to other countries. That is all 
they are there for: They do the inspection. They are done. They 
are out.
    On the domestic side, that inspector may get called away 
for another inspection, a for-cause inspection. They may be in 
the midst of one when they start another. Our field realizes 
they need to shrink that overall time for domestic inspections 
so that companies have better assurances it will be done more 
quickly. The overall time to do inspection, though, is pretty 
much the same. Most of those inspections are done in less than 
4 or 5 days. Some of them are even done in one day.
    In terms of the legislation, it is not inconsistent with 
what our field is doing. In fact, it is complementary. It is 
one of the challenges of the law today is we are supposed to 
inspect everybody every 2 years. Well, there are over 25,000 
medical device facilities worldwide. We do about 2,400 G&P 
surveillance inspections. So we can't even live up to the law.
    And then we are pulled toward you got to see everybody. We 
should be focused on and we can see the value in focus where 
there are the greatest risks and then tailor or our inspections 
appropriately. So that would be complementary to the change 
that ORA is going to make to the program.
    Ms. Eshoo. Thank you.
    Mr. Burgess. The gentlelady's time has expired.
    The chair recognizes the gentleman from Texas, Mr. Barton, 
for 5 minutes of questions, please.
    Mr. Barton. Thank you, Mr. Chairman. It is good to have you 
back. It is good to see you again.
    On the hearing aid issue, what and who determines whether 
you have mild hearing loss or moderate hearing loss?
    Dr. Shuren. So one is there are standards out there, and 
what we will likely do is start looking at, are there ways--
first of all, what matters most is, do consumers get the 
technology that is going to best meet their needs, putting 
aside what the definition of what mild to moderate is? And so 
part of what we are looking at is, are there ways to help 
consumers identify what would be the better technology for 
them? And we are seeing more and more from the technology 
developers then starting to create those services for 
consumers.
    Mr. Barton. Let's say go to Walmart and they are allowed to 
sell over-the-counter hearing aids, would there be some sort of 
a protocol that there would be a sales clerk who could run some 
test and have a chart and say, ``OK, based on this, you have 
got mild,'' or ``based on that, you have got moderate''? 
Something like that?
    Dr. Shuren. I think it is premature to sort of say what 
would be the right mechanism to put in place. That will be part 
of further dialogue. Because if we were to move forward with an 
OTC category, it would be through a rulemaking process. So 
there would be lots of other public engagement. That is why, as 
I mentioned, there is going to be another meeting from the 
National Academies of Sciences that is going to start 
addressing these issues.
    But there are a number of different options that may be in 
place. Like I said, some of the technologies themselves are 
starting to provide or will be providing tools for assessment. 
You may see there is also over-the-counter now audiometric 
testing that is available. And those will be part of a dialogue 
that we would have about, what is the right things to put in 
place?
    The other piece is we would likely also put output limits 
on hearing aids depending upon for which of the patient 
population----
    Mr. Barton. Well, at some point in time, if it were obvious 
that the individual seeking to purchase a hearing aid over the 
counter had more than mild loss, would the entity that was 
selling the over-the-counter hearing aid be required to refer 
them to a specialist so that you prevent somebody who really 
needs more than what the over-the-counter product can provide--
you give them a way that they refer to some of the trained 
people who can help them?
    Dr. Shuren. So I don't want to get ahead of things, but 
that is one of the considerations about what do you do in the 
circumstance if the needs of the consumer is not being met. And 
that may be either through the recommendations we made back to 
the consumers or those who are providing assessment services.
    Mr. Barton. OK. On two of the other bills, 2118, the 
Medical Device Servicing Safety and Accountability Act, that 
would require original equipment manufacturers and third-party 
providers, service providers, to register with the FDA.
    Is that something that is a necessity that we need to do? 
Do you support that, or is that an open question?
    Dr. Shuren. Well, we are still in the midst of looking at 
what would be the appropriate, if any, steps to take regarding 
third-party servicers. What registration does do is it at least 
gives you a window on who are those entities that are providing 
that kind of service.
    Mr. Barton. But under current law, apparently, they are not 
required to register and to maintain a complaint system. So I 
am just trying to figure out, is there an issue in the 
marketplace today that would require that type of legislation? 
Is that a problem that is not being addressed and this is the 
correct remedy?
    Dr. Shuren. Right. And so we are not at the stage where the 
agency or the administration has made a determination one way 
or the other on whether or what action should be taken. But we 
do view, if Congress has a perspective on what we should be 
doing, that would be very helpful.
    Mr. Barton. You mean you are going to listen to the 
Congress? That is refreshing?
    Dr. Shuren. We always do what you tell us to.
    Mr. Barton. You always personally listen.
    And I would ask the same general question about the 1736, 
the modernization of the FDA's risk-based approach. I strongly 
support a risk-based approach and would just be interested if 
the FDA has a position on that legislation.
    Dr. Shuren. Yes. So we do see great value in having a risk-
based approach to inspections.
    Mr. Barton. I yield back, Mr. Chairman.
    Mr. Burgess. The gentleman yields back.
    The chair thanks the gentleman.
    The chair recognizes the gentleman from Massachusetts, Mr. 
Kennedy, for 5 minutes for nonconfrontational questions, 
please.
    Mr. Kennedy. Never, Mr. Chairman. Thank you.
    I wanted to start, Mr. Chairman, in a nonconfrontational 
way by submitting letters of support for the record for AARP, 
the ADA, the National Committee to Preserve Social Security & 
Medicaid----
    Mr. Burgess. Without objection, so ordered.
    Ms. Kennedy. Consumers United--I still have a couple more 
to go. --Hearing Loss Association of America and the Consumer 
Technology Association.
    Mr. Burgess. I could hear you. I just wasn't listening.
    Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Kennedy. I need more coffee this morning. And thank 
you, again, Mr. Chairman.
    Doctor, it is a pleasure to be with you. I appreciate your 
testimony.
    I wanted to flesh out a little bit of your testimony 
earlier, and some of the questions I know have been asked by 
our colleagues on both sides of the aisle, of the dais here 
this morning.
    One of the issues that has come up and that you did comment 
on briefly is around patients' ability to self-diagnose. And 
there is a critique out there saying that patients can't, and 
they are not entirely certain. They might know that they are 
losing some access to hearing, but some uncertainty as to how 
we might be able to craft a product that could meet their need 
given their unfamiliarity with it as a new product in the way 
that people now can go in and buy over-the-counter eyeglasses, 
but it might have been a little bit odd to do so when those 
first came on the market. I was wondering if the FDA might be 
able to--if you could talk a little bit about the concern there 
and what the FDA has done in any research to mitigate that 
concern.
    Dr. Shuren. So, at this point, since we haven't created 
that OTC category, we have not worked through all the issues 
about how patients might be able to appropriately self-diagnose 
and select other technology for them to use.
    So we would go through a public process in crafting that. 
We would look forward to working with, you know, the clinical 
community, the patient community, the industry, and others.
    That is likely to also be an evolving world, as also there 
is more competition in the marketplace. People will compete 
around their ability to provide assessments on hearing loss, 
not just simply the technologies to address hearing loss.
    But all of this, keep in the context of the world today, 
where most people with hearing loss, and they are putting 
themselves at risk, greater risk, for dementia and falling and 
hospitalization, they are just not getting the technology they 
need. So I think whatever we do, there are going to be 
tradeoffs. We have to walk into this with our eyes wide open. 
But the public health challenges today are so great and the 
status quo today is not adequately addressing the needs of the 
majority of patients with hearing loss that an over-the-counter 
hearing aid category could be one way of trying to address 
those concerns if they are done right and ultimately provide 
consumers with more choice.
    Mr. Kennedy. And we have seen some progress already around 
innovation. The FDA did approve an app, if you will, called 
iHear back in 2016, from what I understand, that does--and it 
provides consumers with some ability to discern their needs. Is 
that so?
    Dr. Shuren. That is correct. We will see more of that out 
there, particularly if there is a marketplace for consumers who 
would need testing within an OTC environment.
    Mr. Kennedy. You also touched on a little bit before and 
just now the issue that patients should see a doctor. The 
question goes to whether the loss of hearing might be a 
precursor to a more serious medical condition and that the 
ability to get something, a product, over the counter, might 
delay somebody from going and seeking the more advanced medical 
support that might be able to diagnose such an issue. Can you 
touch on those concerns at all?
    Dr. Shuren. I think the real concern on the medical side 
is, do you have someone with a treatable hearing loss who 
otherwise didn't get medical attention? And then the practical 
reality is that you have only got about 20 percent of the 
people with hearing loss who are going for a hearing aid. And 
then, of those, the anecdotal numbers are anywhere from 60 to 
95 percent of those individuals opt to sign a waiver. So they 
are not even getting a medical evaluation.
    So you have a tiny segment who are getting it. Then, in 
terms of the risky conditions, things like cholesteatoma, 
acoustic neuroma, you add all those up, the really serious 
causes of hearing loss are maybe well under 1 percent. Your 
biggest treatable is probably ear wax, around 1 to 2 percent. 
So you are not likely going to miss many people. And most 
people, they are never going for the evaluation in the first 
place.
    Now, on the flip side, if you had an over-the-counter 
category and we had information out for consumers, we could 
start telling them, ``Look, if you have particular signs of 
symptoms,'' because most of the serious conditions have signs 
and symptoms, ``so if you have drainage from your ear, go see 
your doctor,'' where right now they are not even getting that 
information to notice these. So it is possible, depending upon 
how this is crafted, we might get more people in, at least 
people who should get a medical evaluation, to get one.
    Mr. Kennedy. Thank you, sir.
    And I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Illinois, Mr. 
Shimkus, 5 minutes for questions, please.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Thanks for being here, Dr. Shuren.
    I am going to just kind of focus on this Medical Device 
Servicing Safety and Accountability Act. Can you describe your 
understanding of how medical equipment service providers are 
organized? Do you know how they are organized?
    Dr. Shuren. As an industry or----
    Mr. Shimkus. As an industry, association, et cetera.
    Dr. Shuren. So there are trade associations for third-party 
service providers.
    Mr. Shimkus. Do some of these work for the original 
manufacturers, or do they work for hospitals and clinics, or 
are they independent? Do you know?
    Dr. Shuren. So you have a mix. Some of these are 
independent, and then they may be contracted with by a 
hospital. Some have a very close relationship with the original 
equipment manufacturer. So the industry is somewhat varied.
    Mr. Shimkus. Yes. So, in the second panel, we are going to 
have testimony from Joe Robinson from the Medical Imaging & 
Technology Alliance and then Robert Kerwin from the Association 
of Medical Equipment Remarketers and Servicers, and obviously, 
there is going to be a conflict here between the two.
    Right now, do you believe there is sufficient justification 
for the U.S. to legislate at this time?
    Dr. Shuren. So we haven't taken a position on what, if any, 
is the right course to take. And so part of this dialogue is 
helpful to us.
    Mr. Shimkus. Is there a survey being done or--again, in the 
second panel, in the testimony, you will see some what I think 
anybody would say are egregious photos of quick or maybe not 
even quick repairs to equipment. You don't know if that is a 
one-time snapshot of one piece of equipment, or is that endemic 
of this sector of the healthcare delivery system?
    Dr. Shuren. Right. So what we have at the moment is the 
anecdotes, which you have seen in testimony.
    Mr. Shimkus. Is it anecdote or anecdotes?
    Mr. Shuren. Well, you can comfortably say anecdotes. And 
one of the challenges we face is we don't have reporting 
requirements by third-party services in terms of problems that 
they may encounter or for complaints that they have, adverse 
events that occur, malfunctions, or complaints. And as a 
result, there isn't a great window on exactly what is happening 
out there as opposed to the individual experiences that you may 
get from an equipment manufacturer, from a hospital dealing 
with the service provider. And that is one of the issues of the 
absence of evidence. It doesn't mean the absence of a problem. 
It is just that it is hard to sort of say the state of it 
without having that ability for any kind of postmarket data 
collection.
    Mr. Shimkus. And I think just why I think it is important 
to get information from you all before we move to see how 
endemic this might be as a problem overall because a couple of 
things: In rural America, small facilities, remarketing of 
equipment is very, very important. It is a great use for areas 
that don't have the ability to purchase new. The second thing 
is, obviously, we want these areas to be safe, but we also 
worry about the folks who are servicing those through 
organizations that they don't incur additional costs where, 
then, they don't have the access to those medical device 
technologies in smaller rural areas.
    I would hope that, as we move forward, you could be helpful 
with an analysis to say, yes, it is a huge problem, or, no, it 
is not a huge problem and how we can address this to ensure 
patient safety but also make sure we don't lose access to the 
smaller, more rural communities for the services that can be 
provided.
    So, with that, I think this is a great hearing. These are 
all pretty important bills.
    And I yield back the balance of my time.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentlelady from Michigan, 
Representative Dingell, for 5 minutes of questions.
    The chair recognizes the gentleman from Maryland, Mr. 
Sarbanes, 5 minutes for questions.
    Mr. Sarbanes. I shouldn't take the full 5 minutes.
    Thank you for your testimony. I was just curious, kind of 
as an aside, is the incidence of hearing loss increasing? Is 
there any evidence of that in the population? Not just because 
of an older cohort demographically, but just otherwise.
    Dr. Shuren. We are seeing an increase in hearing loss in 
younger individuals, and that may be due to more people using 
headphones and earplugs.
    Mr. Sarbanes. I am just looking for ammunition for when I 
tell my kids to stop using earphones all the time. So thank you 
for that.
    Dr. Shuren. For ammunition, I would talk to ATF.
    Mr. Sarbanes. I was curious if there are some other 
examples you could give of situations where there was a 
technology and service bundled together in a way that made it 
fairly expensive for people, particularly since there wasn't 
coverage by a private health insurance plan or by Medicare, 
where those, either the bundling has been pulled apart or it 
has led to the kind of over-the-counter solution that we are 
looking at in this particular case, or whether it might have 
led to a reevaluation of whether it ought to be covered by 
Medicare, for example, and then Medicare became a leader on how 
that is handled, in terms of the commercial plans, et cetera. 
Are there any analogies you can point us to that are 
instructive either to the process that you are undertaking or 
generally to our understanding of this particular issue?
    Dr. Shuren. I am not an expert in the area on the bundling 
of payments. So I don't have one offhand that is completely 
analogous. I know some people point to what has happened with 
reading glasses, but there are differences between that 
scenario and hearing aids.
    Mr. Sarbanes. All right. Well, I will save that for another 
panel. Thank you.
    I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from New Jersey, Mr. 
Lance, 5 minutes for questions, please.
    Mr. Lance. Thank you, Mr. Chairman.
    Good morning to you, Dr. Shuren. Regarding the third-party 
medical device servicing industry, do you know, Doctor, how 
many third-party companies are there?
    Dr. Shuren. Offhand, I don't know the exact number.
    Mr. Lance. Thank you. We have a bill, 1736, that tries to 
streamline the communications process during a facility 
inspection between industry and the FDA. If you would, Doctor, 
could you briefly comment on how the proposed changes in the 
bill could improve FDA's ability to oversee device facilities 
and ensure efficient priority resources?
    Dr. Shuren. From the inspection side?
    Mr. Lance. From the inspector side. And do you think that 
it is likely that this would be a significant improvement in 
moving forward?
    Dr. Shuren. So moving forward, for risk-based would be very 
helpful to us. Right now, given where the law is, we try to 
spread our resources around so we have a better sort of window 
on what goes out there. But being just focused on putting our 
resources where they are most needed would just be a smarter 
use of our resources and I think a greater public health bang 
for the buck overall.
    Mr. Lance. Thank you very much.
    And, Mr. Chairman, I yield back the balance of my time.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Missouri, Mr. Long, 
5 minutes for questions.
    Mr. Long. Thank you, Mr. Chairman.
    Doctor, do you believe that there are any safety issues 
introduced in using a contrast agent to image a different part 
of the body than is indicated in the contrast agent label?
    Dr. Shuren. So there are some cases where that may be the 
case. If we are dealing with changes where we now could, like 
under the bill that has been introduced, have the ability to 
now approve some new indications for the use of a contrast 
agent with the medical technology through the device 
presubmission application, I think one of the important 
features is we are able to make that determination based on 
safety and effectiveness, which is what we do, and then the 
ability not to go ahead and approve it if there would be an 
adverse impact on the safety and effectiveness of that contrast 
agent.
    Mr. Long. Are you aware of any examples of the use of 
medical imaging technology with a contrast agent that was 
approved for use in other countries before it was approved for 
use in the U.S.?
    Dr. Shuren. Yes. I don't have offhand, but, yes, there are 
things that occur in other countries that do not necessarily--
--
    Mr. Long. So you are aware that there----
    Dr. Shuren. As I understand. I don't have the----
    Mr. Long. Can you have your folks get with my staff and let 
me know?
    Dr. Shuren. Yes.
    Mr. Long. It is my understanding that the regulatory 
situation for medical imaging devices used with contrast agents 
has gone unresolved for nearly 20 years. What do you think it 
will take for the agency to provide a reasonable regulatory 
pathway for medical imaging devices and contrast agents?
    Dr. Shuren. The challenge we faced is attorneys have 
interpreted that we cannot go ahead and approve a medical 
device with a drug, like a contrast agent in that case, that is 
inconsistent with the drug labeling, for that contrast agent. 
And that has been the problem we have been dealing with all 
these years. We certainly see the value, public health 
benefits, in providing the opportunity for us to now go ahead 
and approve or clear the use of a contrast agent with an 
imaging technology through the device submission and, 
therefore, in the device labeling and maybe inconsistent with 
the drug labeling. And, again, as long as we have the ability, 
which seems to be in the bill, that we wouldn't approve or 
clear if there was an adverse effect on the safety and 
effectiveness of that drug, namely that the inconsistency 
doesn't lead to a problem otherwise in the safety and 
effectiveness of the drug, which that, under the bill, we have 
that ability not to then approve the product in that 
circumstance. This gives us a flexibility that today we don't 
have and gives us the ability to make those approval and 
clearance decisions in a least burdensome manner.
    Mr. Long. OK. Thank you.
    And, Mr. Chairman, I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Oklahoma 5 for 
minutes questions, please.
    Mr. Mullin. I wasn't expecting that. I was expecting 
Bucshon to go next. Your question has been answered?
    Well, thank you so much, Doctor, for being here.
    Thank you, Mr. Chairman, for recognizing me.
    At our last Medical Device User Fee Act hearing, we 
discussed my concerns about the inconsistency that we see 
throughout the agency and especially the inconsistency that we 
see from inspections that happen here versus overseas. Has 
anything changed on that as far as implementing some standard 
operating procedures?
    Dr. Shuren. Well, not since the last hearing.
    Mr. Mullin. Do you think that Mr. Bucshon's bill would help 
this?
    Dr. Shuren. So I think it may not directly address, but the 
opportunities for better interaction/collaboration between the 
inspectors and the firm that is being inspected is a step 
forward, and I think ultimately--and this was a question you 
also had asked the last time--why will it take so long to make 
a change? Because ultimately, the big change that has to be 
made is a change in culture. And that is something the field 
recognizes, but as the head of a center that has been going 
through a culture change, I can tell you it takes a long time. 
Regarding the SOPs, they do plan to change the SOPs for 
conducting inspections so that they are constraining the amount 
of overall time it takes to do a domestic inspection. Right 
now, they have been focused on standing up the organizational 
structure on program alignment, but that will be officially 
launched as of May 15, and then they will be moving on to the 
other things they need to do, like changes in that SOP.
    Mr. Mullin. If you are talking about the culture through 
the agency, how do you change that? I mean, legislation doesn't 
fix that. I was hoping that there would be something that we 
could point to that we could work together. As you and I had 
discussed, we want to work with you. I think my colleague, Mr. 
Bucshon, that is the whole point of this legislation is helping 
to move that process forward to give you authority to build and 
go and implement. I mean, 3 years is what you said at the last 
hearing, that it would take roughly 3 years to implement it. As 
a business owner, I just can't see that. I can't see where it 
would take 3 years. Either people are on board or they are not 
on board; and if they are not on board, then they shouldn't be 
in that position.
    Dr. Shuren. I appreciate that. First off, changes will 
occur in the program. And, again, I am speaking on behalf of 
another part of the agency, but I think people will start 
seeing changes in the program a lot sooner than that. But for 
the full change in the program, quite frankly, to change 
culture, you can't change it overnight. And, honestly, ask any 
company that has been through it, it does take a while.
    Mr. Mullin. Sir, you don't have to ask any company. Ask me. 
I have been through it. We have several businesses. My wife and 
I, we have several hundred employees. I get it. We have 
purchased companies. We brought them in. There has been a 
difference. But when you send out standard operating 
procedures, ``this is our policy,'' they are either on board or 
they are not on board. I understand the personnel, the 
training, and everything else does take time, but implementing 
a policy change shouldn't take 3 years to put in place.
    And we are wanting to work with you. And I think that is 
the whole point of this legislation, is to work with you, but 
we are here to help. So I am not wanting to get in a back-and-
forth with you, but I don't buy the whole thing that it is 
going to take 3 years. Yes, it can take several months. It 
could even take 12 months to completely change because it does 
take time to go through and educate people. Three years, 
though, at some point, they are not interested in doing their 
job. At that point, they are interested in just getting a 
paycheck, and that has to change.
    Dr. Shuren. I appreciate that. And I do think in terms of 
getting to less time spent for domestic inspections, the 
overall time, that is not going to take years. That will take 
significantly less time. Putting the SOP in place, making 
changes, getting people trained up on that, and implementing 
that, I agree with you, is more on the order of a shorter term 
undertaking.
    Mr. Mullin. And you may answer this, and then I will yield 
back after this, but do you support this legislation that my 
colleague is trying to push forward?
    Dr. Shuren. We do see the value in moving to risk-based 
inspections and the importance of having better interaction and 
collaboration between the inspectors and the firms being 
inspected. And we do need, for export certificates, having that 
better streamlined and the resources we need to fully implement 
that and provide the export certificates can be helpful.
    Mr. Mullin. So I am going to take that as a yes.
    Dr. Shuren. [Nonverbal response.]
    Mr. Mullin. All right.
    Mr. Chairman, I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Georgia 5 minutes 
for questions, please.
    Mr. Carter. Thank you, Mr. Chairman.
    Doctor, thank you for being here.
    Some real quick questions, and then we will be done. I just 
want to make sure that we do have indepth studies that we can 
point to, for instance, from the President's Council of 
Advisors on Science and Technology and also from the National 
Academies of Sciences, Engineering, and Medicine, that they 
have noted through indepth studies that the requirement to 
obtain a medical evaluation before getting a hearing aid has 
really provided little usefulness and really become a barrier. 
True?
    Dr. Shuren. True.
    Mr. Carter. Secondly, that there is really no credible 
research that demonstrates that the medical evaluation 
requirement actually leads to the identification and treatment 
of conditions that you wouldn't probably catch anyway.
    Dr. Shuren. So, while there can be value in a medical 
evaluation in select individuals, on a population basis and as 
it is currently applied, we see very little value.
    Mr. Carter. Very little. OK. And then, thirdly, there is 
really no evidence that the required medical evaluation as a 
condition to purchasing a hearing aid is going to improve the 
outcome for a patient seeking hearing health care?
    Dr. Shuren. No. I agree, within the current context of 
today, no, because also most people aren't even coming for the 
medical evaluation, or they are signing a waiver not to do it.
    Mr. Carter. Right. Right. OK. Finally, you are comfortable, 
you are comfortable that making hearing aids available OTC and 
unregulated devices, like the personal sound amplifiers, that 
this is not going to be somehow dangerous to consumers?
    Dr. Shuren. We think that overall for the population of 
patients with hearing loss, this is likely going to be that we 
will receive greater benefit from this approach than harm that 
may occur.
    Mr. Carter. So the benefit outweighs the risk?
    Dr. Shuren. Yes.
    Mr. Carter. Thank you, Mr. Chairman. I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Michigan, Mr. 
Upton, 5 minutes for questions, please.
    Mr. Upton. Thank you. I was sorry I didn't get the door 
opened fast enough. It was stuck when I came in the door, which 
is why it slammed. So I didn't get here in time for the gavel. 
But most of my questions have already been asked. So I just 
want to take this opportunity to again thank you for your help 
on 21st Century Cures. From the beginning, we wanted to make 
sure that the FDA, both on the device side and the 
pharmaceutical side, had the right resources to be able to 
expedite the approval of these, particularly in a domestic way, 
knowing the jobs would stay here. And your participation 
nationwide was extremely helpful and constructive.
    I know that one of the major issues that this subcommittee 
is going to be looking to move with Dr. Burgess' and Chairman 
Walden's support is both the PDUFA and the MDUFA bill. And I 
would hope that we could move those in the next number of weeks 
because we are all concerned that, without those resources, you 
will have to RIF the people that are there in the agency to 
make these various approvals by midsummer or so. So I just want 
to thank you for your good work. We look forward to continuing 
to partner with you and make sure that you have the appropriate 
resources to really benefit Americans as well as folks all 
across the globe.
    So, with that, I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentlelady from Michigan, Mrs. 
Dingell, 5 minutes for questions, please.
    Mrs. Dingell. Thank you, Mr. Chairman. Thank you for 
allowing me to sit on the subcommittee today. I think this is a 
very important hearing, and it, quite frankly, is one of my 
passions, and I am going to confine myself to the OTC hearing 
aid legislation introduced by Mr. Kennedy and thank him for his 
leadership on the issue. It has been one of the issues that I 
have been working on since coming to Congress. So I have my own 
legislation I would love to lobby my colleagues on to ensure 
that Medicare covers hearing aids.
    Many of my questions have been answered, but I think I 
would like to clarify some of the numbers because I think 
people don't understand what the real impact is in society 
today and what is happening to people. Hearing loss is a 
quality of life, plain and simple. Nobody should feel isolated, 
confused, or shut out. And you and I both know, and so many of 
us in this room, that a lot of people are just because they 
can't afford to get the treatment they need; they don't have 
access.
    Because of the groundbreaking research done by my friend, 
Dr. Lin, who we are going to hear from later, we know that 
hearing loss is linked to increased hospitalizations, and now 
we are beginning to see even dementia, early-onset Alzheimer's. 
So, to me, it is clear that we would have potential in reduced 
health costs and improved outcomes by increasing access to 
hearing aids. I think you would agree with me on that?
    Dr. Shuren. Yes.
    Mrs. Dingell. Thank you. So let me just clarify some 
figures because we have been dancing all around it. Dr. Shuren, 
is it correct that the National Academies of Sciences found 
that 30 million Americans today suffer from hearing loss?
    Dr. Shuren. Yes.
    Mrs. Dingell. And is it also correct that the prevalence of 
hearing loss increases with age?
    Dr. Shuren. Yes.
    Mrs. Dingell. Forty-five percent of people age 70 to 74 
have hearing loss, and 80 percent 85 or older is what I am 
told. Is that pretty much what you have been told too?
    Dr. Shuren. That sounds about right.
    Mrs. Dingell. But even though it is a common condition and 
hearing aids have been around for decades, most people don't 
have access, and it has got a negative impact on their overall 
health. Is it correct that 67 to 86 percent of adults who may 
benefit from a hearing aid do not have access to one?
    Dr. Shuren. Yes, that is about right.
    Mrs. Dingell. The National Academies of Sciences I think 
said that only 15 percent of people who need the hearing aids 
of the 30 million may have actual access to them. So would you 
agree that the high cost of hearing aids is a major reason and 
that more people who suffer from hearing loss are not using 
them, and we need to find a way to do that?
    Dr. Shuren. Well, we do need to find a way to have better 
access, and our understanding is that cost is one of the 
drivers.
    Mrs. Dingell. You talked about it in your earlier comments, 
that you issued the guidance not enforcing the FDA regulations 
that mandates the medical evaluation. Do you believe that 
creating an over-the-counter category for hearing aids will 
lower costs? You kind of danced it. You wouldn't commit to it. 
How far are you willing to go today to tell us how you think 
that that might be letting the marketplace work might help?
    Dr. Shuren. We do think that, certainly in other scenarios, 
the marketplace would drive down the cost of those products, 
particularly as they are offered over the counter.
    Mrs. Dingell. And it is important that we continue to put 
patient safety first. Anna and I have been sitting here, my 
colleague and I, for this entire time, but new innovative 
hearing aids are now more safer than ever, I understand. Is it 
correct that FDA did not receive any reports of corrections or 
removals regarding hearing aids between 2011 and 2015, and what 
does that tell us about the safety of products that are already 
on the market?
    Dr. Shuren. I believe that is the case. I will have to go 
back to confirm.
    Mrs. Dingell. And from an FDA workshop. Not that I studied 
the issue or anything. So, to me, it is clear that the current 
market is broken. I thank you for your work and hope we can all 
work together to find a way to really address this hearing 
issue.
    Thank you, Mr. Chairman.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair recognizes the gentlelady from Indiana, Mrs. 
Brooks, 5 minutes for questions, please.
    Mrs. Brooks. Thank you, Mr. Chairman.
    I am very pleased that the committee is examining 
legislation. I worked with my Hoosier colleague, Congressman 
Bucshon, Mr. Peters, and Mr. Butterfield, because the goal of 
H.R. 1736 is to bring more predictability and consistency to 
the device inspection process, and I hope the committee will 
include this bipartisan, bicameral measure in the final user 
fee agreement.
    But I also appreciate the committee's attention to the 
oversight of third-party medical device service providers, 
because concern for patient safety should drive our decisions 
here. And when there are questions around how the work of some 
bad actors can hurt patients, it is our responsibility to 
examine this current system and see how we can improve on it. 
But, further, for those service providers who operate 
responsibly, we must be conscious of the precedent that 
legislation we might consider or might get set under H.R. 2118 
certainly warrants discussion. I appreciate the opportunity we 
have here today.
    Dr. Shuren, maintaining a safe and effective medical 
equipment management program is vital to any hospital or 
healthcare system. And according to industry estimates, a 
medium-size hospital can spend $5 million per year on equipment 
maintenance. An average-size health system can spend up to $50 
million per year on such costs. TriMedx, which is located in my 
district, is the country's largest independent third-party 
service provider of medical equipment. They employ and manage 
almost 1,500 associates, who maintain more than 1.7 million 
pieces of equipment in over 240 hospitals across 32 states.
    Mr. Chairman, I would ask unanimous consent to support 
TriMedx's written statement for the record. Thank you.
    [The information appears at the conclusion of the hearing.]
    Mrs. Brooks. Dr. Shuren, independent third-party service 
providers--and you talked about the importance, especially 
after receiving comments kind of on both sides of this issue--
who deliver this in-house medical equipment service, repair, 
and maintenance, such as TriMedx, act as agents for their 
hospital customers and ensure that their hospital customers 
comply with applicable regs. This includes, of course, 
overseeing or assisting with any internal investigations and 
reporting required. Because hospitals are already required, as 
I understand, to provide this information to the FDA, do you 
consider it redundant to also require third-party service 
providers to deliver the same information to the FDA?
    Dr. Shuren. I think one of the issues is there is different 
information to be provided regarding problems that may be 
occurring with those devices in terms of servicing. For 
example, if there are complaints that are received by the 
third-party servicer, how are those being handled? Are they 
being followed up on? Are there records of them?
    And you raised an important point. From what we understand 
in the marketplace, third-party servicers, the quality of what 
they provide runs the gamut. You have some exceptional firms 
who provide excellent servicing, and you have some that, from 
what we can tell, do not provide the same level of quality. 
There is sort of a discrepancy within the marketplace.
    Mrs. Brooks. But the third-party service providers, their 
customer is the hospital. And when you say there is different 
information, is that information that could be provided to the 
FDA by the hospital if the hospital required it of the third-
party providers?
    Dr. Shuren. So some of that information wouldn't be 
information that a hospital otherwise would be required to 
report to the FDA.
    Mrs. Brooks. But the hospital does have a number of 
requirements, of course, that it is required to provide. And so 
would that be an expansion of hospital requirements, because I 
don't think a patient--and certainly, this is not always based 
on patient issues, but the technicians and other issues. Anyone 
would go to the hospital, would they not, with issues with 
respect to equipment in their own hospitals?
    Dr. Shuren. No. So they may have equipment that is used on 
them, and they may complain to the original manufacturer, may 
complain to their doctor, any number of places where they may 
complain. And for the hospital's device user facilities, there 
is authority for sort of limited reporting to the FDA, which is 
different from the fuller spectrum of requirements that could 
apply--do not have to apply--to manufacturers, such as third-
party servicers.
    Mrs. Brooks. And all of the items when you gave your 
opening testimony that you listed as issues about third-party 
service providers or that the third-party service providers had 
about the manufacturers, is there a way, in your opinion, to 
remedy that nonsharing of information between the manufacturers 
and the independent service providers?
    Dr. Shuren. There may be a way to do that. I mean, we 
certainly have in cases where there is high risk, higher risk, 
we have required that information on servicing and maintenance 
is made available with the technology. So we have done that, 
for example, with laser products.
    Mrs. Brooks. Thank you. I am sorry. My time is up.
    I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    Dr. Shuren, we do thank you for being here. Ranking Member 
Green and I each had one follow-up observation or question, and 
I am going to go to Mr. Green first for his question.
    Mr. Green. Thank you, Mr. Chairman.
    Dr. Shuren, can you discuss the rules and requirements that 
currently apply to third-party service providers? For example, 
are they required to register with the FDA, label products they 
have repaired or remanufactured, or submit adverse event 
reports associated with their work?
    Dr. Shuren. So, in our regulation on quality systems, we 
had made clear that third-party servicers are manufacturers, 
but they have been subject to enforcement discretion. We have 
not enforced those requirements.
    Mr. Green. OK.
    Thank you, Mr. Chairman.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    Dr. Shuren, we are going to hear testimony in just a few 
minutes from the Medical Imaging & Technology Alliance. And in 
that testimony, in the written testimony that was provided to 
the subcommittee, they talked about December 2009, the FDA 
released a guidance document entitled, ``Guidance for Industry 
for New Contrast Imaging Indication Considerations.''
    And that guidance was apparently part of an agreement under 
the medical device user fee amendments of 2007. I was here in 
2007 on this committee. I sat way down in the front row on the 
minority side. You were not at the agency in 2007, were you? Do 
I recall that correctly?
    Dr. Shuren. I was at the agency, but in a different 
position.
    Mr. Burgess. In a different role. So I guess my observation 
or where you could be helpful to this subcommittee is, 
obviously, we want to get this done. And you heard Chairman 
Upton talk about the timeliness being important, and certainly 
everyone on this subcommittee feels that.
    At the, same time, when I am reading this paragraph from 
the testimony from one of our next witnesses, Mr. Robinson, it 
occurs to me that language we put forward in this user fee 
agreement, I mean, here it is 10 years later, from 2007 to 
2017. And I guess my request to you was, we so want to get this 
done, but we also want to get it done correctly, and we don't 
want to leave the burden in 10 years' time to another Congress 
to deal with problems that we have created that turned out to 
be insurmountable without another user fee agreement. Do you 
understand what I am asking of you?
    Dr. Shuren. I do. And I think the guidance that was put out 
in 2009 went as far as the agency was able to go under current 
law. So it has not addressed the concerns that we are seeing 
from the imaging technology makers and also by the contrast 
makers too, who have come together, I know, with a proposal.
    So the bill, the value on the bill, we can see the 
potential public health value of now addressing situations that 
we could not address under the current law but may make sense 
to do for public health purposes.
    Mr. Burgess. Very well. I thought we were through with 
questions, but I see the gentlelady from Tennessee is here. Let 
me yield to her 5 minutes for questions.
    Mrs. Blackburn. Well, thank you so much. And I am not going 
to use 5 minutes. I apologize. I had to skip to a meeting.
    I want to echo what Mr. Green said about the SOFTWARE Act 
and your work there with us. We were pleased to get that across 
the finish line in 21st Century Cures.
    And on the over-the-counter hearing aid, I honestly believe 
this is something that does answer a problem. And for my 
colleagues, I give you a great example. I have a 92-year-old 
mother who is a pistol, and she is into everything. She is a 
busybody. They told her she needed a hearing aid, and she 
didn't like that. So she doesn't wear the hearing aid because 
she needs to go back to the doctor to get it fixed. Now, 
somebody like my mother, who is a DIY aficionado, if she can't 
fix it herself, it is just going to have to wait because she 
doesn't have time for it. This is the kind of person who would 
buy it at the pharmacy, would go read it, and then would be 
able to use it because she has got one over here she can't use 
because it means she has to set an appointment and interrupt 
her day and get to the doctor and get back. And I think that is 
where, you know, for someone that has a mild or moderate 
hearing loss and knows it and is aware of it, this is an item 
of convenience. And just as readers have been a boon for baby 
boomers because you need a little bit of help reading, but you 
don't have any serious problems, or shoe inserts--look at how 
that has helped for people with orthopedic issues--or bandages 
or wraps or Benadryl cream, any of those other things that have 
moved to over the counter.
    So I do see it as being consumer-friendly and something 
that, as you do have a generation of baby boomers coming along, 
will move people in the right direction for getting the health 
care they need. How many times have we heard people say, 
``Well, I have outgrown my readers. So I need to go and get a 
different''--oh, Billy Long, I know that is you. You are 
outgrowing your readers there.
    So, anyway, I just want to thank you for that. I do know 
that from what you have said--you have already answered the 
question that I have--is that you rely on the research from the 
National Academies and the guidance from the National 
Academies. So I thank you for that.
    I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    And, Dr. Shuren, this will conclude the question portion of 
this hearing. And we want to thank you for spending so much 
time with us this morning, and thank you for your thoughtful 
answers to the questions from the committee.
    We are not going to recess. We are just going to go 
directly into our second panel.
    So, Dr. Shuren, you are excused.
    And we will get our second panel seated and immediately 
transition into opening statements from the second panel.
    We do want to thank the witnesses on the second panel for 
taking time to be here today, taking time to testify before the 
subcommittee. As a reminder, each witness will have the 
opportunity to give an opening statement, and then this will be 
followed by questions from members.
    We will wait for the second panel to be seated, and I will 
introduce them.
    Again, we thank our second panel for being with us today. 
Introducing down the witness table, starting with Dr. Thomas 
Powers of Powers Consulting; Dr. Frank Lin, Associate Professor 
of Otolaryngology, Johns Hopkins University; Mr. Joe Robinson, 
Senior Vice President of Health Systems Solutions, Philips 
North America; Mr. Robert Kerwin, General Counsel, 
International Association of Medical Equipment Remarketers and 
Services; and Ms. Patricia Shrader, Vice President of Global 
Regulatory affairs at Medtronic. We appreciate all of you being 
here today.
    I will begin the panel with Dr. Powers. You are recognized 
for 5 minutes for a summary of your opening statement, please.

  STATEMENTS OF THOMAS POWERS, PH.D., POWERS CONSULTING, LLC; 
FRANK LIN, M.D., PH.D., ASSOCIATE PROFESSOR OF OTOLARYNGOLOGY, 
 HEAD AND NECK SURGERY, GERIATRIC MEDICINE, MENTAL HEALTH, AND 
 EPIDEMIOLOGY, JOHNS HOPKINS UNIVERSITY; JOE ROBINSON, SENIOR 
    VICE PRESIDENT, HEALTH SYSTEMS SOLUTIONS, PHILIPS NORTH 
    AMERICA; ROBERT KERWIN, GENERAL COUNSEL, INTERNATIONAL 
ASSOCIATION OF MEDICAL EQUIPMENT REMARKETERS AND SERVICERS; AND 
 PATRICIA SHRADER, VICE PRESIDENT, GLOBAL REGULATORY AFFAIRS, 
                           MEDTRONIC.

               STATEMENT OF THOMAS POWERS, PH.D.

    Mr. Powers. Chairman Burgess, Ranking Member Green, and 
members of the subcommittee, thank you for inviting me today. 
My name is Thomas Powers. I am currently a consultant to the 
hearing health industry. I received my doctorate in audiology 
from Ohio University and was in an audiology-based private 
practice and spent 35 years working in the hearing health 
field.
    I am speaking today on behalf of the Hearing Industries 
Association, which is the national association of hearing aid 
manufacturers. These companies spend over $600 million per year 
on research and development for hearing aids which are at the 
cutting edge of hearing technology. HIA is supportive of 
efforts to enhance hearing affordability and accessibility.
    We note that the market is already adapting to expand 
access and affordability. Big-box stores, such as Costco and 
Sam's Club, now account for more than 10 percent of the market. 
In addition, CVS last week announced its major entry into the 
hearing aid market. All of these channels include professional 
testing, fitting, and follow-up.
    NAS has recommended the creation of an OTC category of 
hearing aids, and we agree that such a category should be 
regulated by FDA, to ensure such products are safe and 
effective. As with existing hearing aids, OTC hearing aids 
should be required to demonstrate effectiveness through FDA's 
review process, as are other medical devices. Also, FDA should 
clearly differentiate hearing aids from unregulated personal 
sound amplifiers.
    There are no studies to demonstrate that a person with 
hearing loss can accurately self-diagnose the degree and cause 
of their hearing loss. However, we believe that an OTC option 
may still provide a gateway to the hearing health treatment for 
many, if that option were promoted carefully and with the risks 
minimized.
    When people finally address their hearing loss, often after 
many years of delay, if an OTC device promoted as a solution 
fails to meet the expectations, this may lead to frustration, 
further treatment delay, and even abandonment of efforts to 
address their hearing loss. Such treatment failure leaves the 
individual at greater risk of isolation, depression, falls, 
dementia, and other conditions related to untreated hearing 
loss. Given this risk, it is critical that OTC hearing aids be 
recommended for people with mild hearing loss, where the risks 
of failure and further delay of treatment are reduced. H.R. 
1652, as drafted, would mandate the FDA recommend OTC hearing 
aids for people with moderate hearing loss as well.
    Mild hearing loss is marked by having difficulty hearing 
soft speech sounds. Professionally fit hearing aids would 
certainly benefit this group. Mild hearing loss, as we have 
heard, impacts two-thirds of all Americans with hearing loss, 
although only 12 percent of these individuals currently use 
hearing aids. And, firstly, about 50 percent of individuals 
with moderate hearing loss use hearing aids. The degree of 
hearing loss is measured via an audiogram, using a decibel 
scale, and is classified by the FDA in five ranges, according 
to normal to profound. And I would like to enter this chart 
from the FDA into the record.
    Mr. Burgess. Without objection, so ordered.
    [The information appears at the conclusion of the hearing.]
    Mr. Powers. Mild hearing loss ranges from 20 to 40 decibels 
loss; and moderate loss ranges from 40 to 70. A moderate 
hearing loss is not an insignificant condition. From my 35 
years of experience in audiology, simple amplification is not 
ideal for people with a moderate hearing loss, as they may have 
more complicated audiometric configurations, such as high-
frequency loss or hearing loss in the middle or low 
frequencies.
    In addition, as the hearing loss progresses to the moderate 
category, the ability to understand speech may decrease 
significantly. Simply providing amplification across the range 
of speech frequencies may not provide the anticipated benefits 
and could lead to frustration with the process.
    We do believe that FDA should create strict labeling 
requirements for the OTC hearing aids. Given this reliance on 
labeling, we believe it is more important that Congress and FDA 
only recommend OTC hearing aids for people with mild loss. 
People who have had their hearing loss diagnosed at a moderate 
level should be discouraged from self-treatment options. Output 
limits proposed in this legislation should be configured to set 
the gain levels appropriate for mild loss.
    Access and affordability are important goals, but creating 
a new OTC hearing aid category should be done with care. 
Focusing on people with mild hearing loss would minimize the 
risks while at the same time providing an option for the vast 
majority of people with hearing loss who have not yet entered 
the hearing healthcare system.
    Thank you very much.
    [The prepared statement of Mr. Powers follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. The chair thanks the gentleman.
    Dr. Lin, you are recognized for 5 minutes for an opening 
statement, please.

              STATEMENT OF FRANK LIN, M.D., PH.D.

    Dr. Lin. Chairman Burgess, Ranking Member Green, and 
members of the subcommittee, thank you for inviting me here 
today. My name is Frank Lin, and I am an associate professor in 
the Johns Hopkins School of Medicine and the Johns Hopkins 
Bloomberg School of Public Health. From a clinical perspective, 
I am a board-certified otolaryngologist with fellowship 
training in otology and an expert in the medical and surgical 
management of hearing loss and other conditions affecting the 
ear. From a research perspective, I am a public health expert 
on the impact that hearing loss has on older adults and 
society. My interest in and testimony on the Over-the-Counter 
Hearing Aid Act stems directly from this background.
    The OTC hearing aid bill, which we have been discussing, 
introduced by Representatives Kennedy, Carter, and Blackburn, 
directly reflects the early recommendations made by two expert 
committees: the President's Council of Advisors on Science and 
Technology, or PCAST, in 2015; and a National Academies of 
Sciences, Engineering, and Medicine consensus study in 2016. I 
advised PCAST on their report and was also a member of the 
National Academies' expert committee.
    Both of these expert bodies concluded that the creation of 
an FDA regulatory classification for OTC hearing aids for mild 
to moderate hearing loss would immediately benefit public 
health and Americans. The importance of the present bill 
instructing the FDA to carry out this recommendation is immense 
for public health. Over the past several years, research from 
Johns Hopkins as well as other academic institutions has 
clearly demonstrated that hearing loss, while being a usual 
process of aging for all Americans, is not without consequence. 
These studies have demonstrated that individuals with hearing 
loss are at a greater risk of developing dementia, having 
falls, and having greater healthcare costs. These research 
studies also clearly suggest that hearing loss treatments, such 
as using hearing aids, potentially decrease these risks and 
lead to real and tangible benefits for society.
    And yet, currently, less than 20 percent of nearly 38 
million Americans with hearing loss currently have access to 
hearing aids. The reason for this low rate of use stems largely 
in part from the current regulatory framework that only allows 
for a one-size-fits-all model of obtaining hearing care; that 
is, for an average American nowadays to obtain hearing aids, he 
or she has to make repeated trips back and forth to a licensed 
hearing professional, who basically serve as the gatekeepers 
now to consumers being able to obtain hearing aids. While this 
model is clearly appropriate for people with more severe 
hearing losses and more complex hearing losses, this model is 
extremely expensive, and it is clearly not needed by every one 
of the 38 million Americans with hearing loss. At present, the 
average cost of obtaining two hearing aids is about $4,700, 
which, when put into perspective, means that, for the average 
American, a pair of hearing aids could be their third largest 
material purchase in life after a house and a car.
    The passage of the OTC hearing aid bill would allow for 
hearing aids meeting explicit performance standards that would 
ensure safety and effectiveness for mild-to-moderate hearing 
loss to be directly available to consumers. Based on the 
scientific literature, the best studies we have to date, such 
devices could safely provide levels of amplification that would 
be effective for individuals with mild to moderate hearing 
loss. Both established hearing aid manufacturers as well as 
consumer technology companies that have economies of scale in 
manufacturing would then be able to enter the marketplace to 
sell devices directly to consumers that will come at a lower 
cost as many more are sold.
    Importantly, the availability of OTC hearing aids for mild 
to moderate hearing loss does not in any way preclude the 
invaluable services in counseling, education, device 
programming that a hearing professional could provide. One 
would expect--and we already see this, actually--that many 
adults would, in fact, still want to seek out a hearing 
professional to learn how to use the devices and customize the 
device to their hearing needs, while others may learn to use 
these devices on their own, much like any other consumer 
electronic.
    The important point is that the availability of OTC hearing 
aids for mild-to-moderate hearing loss would bring hearing 
technology out from under the explicit control of hearing 
professionals, such as me, and allow consumers to choose what 
level of hearing care best meets their own needs and 
priorities.
    I should note that some critics of OTC hearing aids 
commonly raise concerns about the safety of these devices to 
consumers, the risk of children using these devices, and 
whether these devices should only be for mild hearing losses. 
While, as a medical and surgical expert on hearing loss, I can 
appreciate where these concerns are coming from; these concerns 
are misguided and more often than not are being raised by 
parties who are more interested in preserving the status quo 
rather than truly improving the lives of Americans with hearing 
loss and advancing public health. These latter priorities are 
what mainly concern me as an academic as well as a physician, 
but also concern PCAST and the National Academies in their 
recommendations that serve as the direct basis of the wording 
of the over-the-counter hearing aid bill.
    I provide a more extensive discussion of these concerns in 
my written testimony, and I am also more than happy to address 
further in questions from any of the subcommittee members. 
Thank you for allowing me to share my views with you.
    [The prepared statement of Dr. Lin follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes Mr. Robinson 5 minutes for questions, 
please.

                   STATEMENT OF JOE ROBINSON

    Mr. Robinson. Thank you, Chairman Burgess, Ranking Member 
Green, and distinguished members of the subcommittee. Thank you 
for the opportunity to appear before you today to discuss 
improvements to the regulation of medical technologies.
    I am Joe Robinson, senior vice president of Health Systems 
Solutions at Philips North America and the chair of the MITA 
board of directors. I am here today to testify on behalf of the 
Medical Imaging & Technology Alliance in support of H.R. 2009, 
the Fostering Innovation in Medical Imaging Act, and H.R. 2118, 
the Medical Device Servicing and Accountability Act.
    Before I get started, I want to also indicate MITA's 
support for H.R. 1736, also the subject of the hearing, to make 
improvements to the FDA's inspection process. And I will tell 
you that, after listening to my colleagues here on the panel, I 
very much support your hearing aid bill as well.
    Let me start with contrast, H.R. 2009. Contrast agents may 
be prescribed by physicians for use with diagnostic imaging 
equipment to enhance imaging, allowing for improved 
visualization and characterization of organs and tissue. The 
use of contrast agents has become an essential part of the 
clinical practice for a variety of imaging modalities. The FDA 
has not been willing to approve or clear imaging devices or 
enhancements for use with current approved contrast agents if 
they are not also labeled for that use, as Dr. Shuren had 
mentioned earlier. FDA believes that their regulations prevent 
them from doing so.
    The purpose of H.R. 2009 is to provide clarification to the 
agency on an appropriate clearance approval pathway for imaging 
devices with contrast agents. Neither physicians nor patients 
benefit from the current situation, as new innovations are 
being held up at the agency, I believe you referenced earlier, 
since 2007, which was part of our submission. This legislation 
would allow patients to move in the U.S. to have more rapid 
access to new imaging technologies that involve the use of 
contrast agents.
    MITA and CORAR have been working collaboratively with the 
FDA for decades to find a reasonable solution to the issue. In 
fact, the topic was addressed, as, again, I referenced just a 
moment ago, in MDUFA II, the agreement of 2007.
    Mr. Chairman, you brought that up yourself.
    Ten years later, the problem has yet to be resolved and 
continues to hinder the agency's goals of fostering innovation, 
improving patient safety, and promoting public health. This 
legislation builds on the 2017 user fee agreements, reduces 
unnecessary regulatory hurdles, and allows patients in all 
communities to access cutting-edge innovation and diagnostic 
imaging that helps physicians detect disease earlier when it is 
more treatable.
    To address service, H.R. 2118. As medical imaging device 
manufacturers, we are not only responsible for making the 
devices, but we also often provide servicing activities for 
devices, both our own devices and manufactured by other 
companies. There are also a number of non-manufacturer 
independent service organizations who repair and maintain 
medical devices. In what is probably a surprise to many, 
currently only service activities performed by a manufacturer 
are regulated by the FDA. Service activities performed by a 
third-party independent service organization do not have the 
same oversight or quality, safety, and regulatory requirements. 
Third parties are not even required to register with the FDA--I 
believe that came up earlier in some of the questions--creating 
an enormous blind spot. Unfortunately, unregulated third 
parties have caused a number of patient safety issues in their 
attempts to repair medical devices. We have raised these 
concerns with the FDA and included examples in my written 
testimony, which I believe all of you received. In raising 
these issues, some have questioned our motives, accusing us of 
wanting to overburden third-party service providers. I want to 
emphatically state that our only goal is to ensure that all 
service and maintenance always results in safe and effective 
operation of medical devices. This is a patient safety issue, 
pure and simple.
    H.R. 2118 takes an important first step toward the 
accomplishment of this goal by requiring that all independent 
service organizations step out of the dark and register with 
the FDA, file adverse event reports, and maintain a complaint 
handling system. That is it; that is what we are asking for 
here today. These are reasonable, basic requirements which 
device manufacturers already meet, by the way, 80 percent of 
which are small businesses with fewer than 20 employees. These 
are minimum requirements that will give the agency information 
about how many businesses are engaging in servicing medical 
equipment and we hope will help get a better handle on adverse 
events to ensure that they never happen again. From a patient 
safety and adverse event avoidance perspective, this is the 
very least we can do for patients.
    Patients and doctors have enough to worry about. H.R. 2118 
seeks to protect patients and ensure effective device 
performance, to increase visibility and accountability for the 
medical device servicers. MITA urges Congress to include both 
H.R. 2009 and H.R. 2118 in the MDUFA IV reauthorization. 
Passage of both of these bills will protect the patient safety 
and ensure timely access to the most innovative technologies.
    I want to thank you for the opportunity to testify and 
present my views in front of you today. I am happy to answer 
questions.
    [The prepared statement of Mr. Robinson follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. The chair thanks the gentleman.
    Mr. Kerwin, you are recognized for 5 minutes for an opening 
statement.

                   STATEMENT OF ROBERT KERWIN

    Mr. Kerwin. Thank you, Mr. Chairman, Ranking Member Green, 
and members of the subcommittee, for this opportunity.
    On behalf of the International Association of Medical 
Equipment Remarketers--we call ourselves IAMERS--we wish to 
express our thanks to the committee in permitting IAMERS to 
testify on behalf of the independent service organizations and 
small-business owners in our diagnostic imaging association. 
IAMERS members sell and service diagnostic imaging. We are not 
in the dark. We sell MRIs, CT, ultrasound, nuclear medicine, 
and general radiography. They are often alumni of OEM training 
programs who have gone on their own and service equipment at a 
much lower price in regional and rural hospitals. And we also 
assist the manufacturers, who may find a need for their 
assistance on multivendor programs.
    Without further ado, we wanted to offer the top five 
reasons why this legislation should not be supported.
    Reason No. 5: This is a solution for which there has been 
no evidence of a problem. As with the auto industry, not every 
repair needed go to a dealer or manufacturer. We are speaking 
of manufacturers as the largest companies in the world. Our 
small- and medium-size businesses have been safely serving and 
servicing without registration with the FDA for many years. 
While some can present anecdotal stories of bad workmanship--
and we, in turn, can present some on behalf of the manufacturer 
should that have any merit, and we think not--there has been no 
evidence to support a systemic problem. I am sure the hospitals 
would be contacting this body if such were happening, but don't 
take our word.
    The respected scientific research institute, ECRI, after 
reviewing FDA MAUDE reports, has concluded there is no evidence 
to date that a patient safety problem exists.
    The American College of Clinical Engineering also weighed 
in and commented that there is no real-world evidence needed to 
support further regulation.
    The Joint Commission commented, ``No knowledge of any 
statistically significant level of safety problems resulting 
from activities of any kind of maintenance/service providers.''
    Penn State Health commented: very little evidence of 
systemic problems existing.
    Reason No. 4: Independent service organizations offer their 
services at a significantly lower cost than manufacturers--$150 
to $200 per hour versus $500 to $600 per hour, with a 4-hour 
minimum in some cases. Although, once competition is in the 
marketplace, we sometimes hear that, in fact, the manufacturers 
do lower their price. Our people are important for 
manufacturing competition.
    Registration, however, with the FDA, as this legislation 
would require, is, respectfully, a changed equilibrium and much 
more than filing a piece of paper. The act is burdensome and a 
costly process and would seek to impose many of the 
requirements currently imposed on a manufacturer for quality 
system service.
    Reason No. 3: With the extra paperwork comes significant 
additional cost to be shouldered by the small- and medium-size 
business owners or passed on to the owners or possibly not 
continue. As detailed specifically or more specifically in my 
written statement, the complaint management system, the 
staffing, the training, the assessment costs, the outside 
auditors, there are significant additional costs that this 
legislation would require compliance with 21 CFR 820.198. This 
section basically requires every repair that is done to be 
cataloged, documented, and processed. In an area of smart 
regulation, this seems to be at odds.
    Reason No. 2: This legislation will hurt rural and regional 
health care. The National Rural Health Care Association reports 
on its Web site that more than 75 rural hospitals have closed 
and 673 are vulnerable. Some of our members, indeed, service 
rural America. These are the small hospitals with dedicated 
staff but not all the resources of the larger facilities, and 
they depend on independent service organizations. Imposing 
these extra costs will require dealing with it somehow, some 
way, and perhaps passing those costs on. We are not seeing the 
corresponding benefit in either adding the cost or potentially 
having independent servicing less accessible. If this was such 
a significant problem, we again say, why have we not heard the 
hospitals clamoring for this?
    Reason No. 1: Put aside all the reasons for the moment. 
There is a body of information--the chairman referred to it--
which may be tapped from the 177 comments to the FDA public 
record and the 2 days of an FDA workshop on this issue last 
year, in October of this last year. This information in its 
totality will not support passage of this act. And I ask 
respectfully--and I believe Dr. Shuren may have referenced it--
if the transcript of the 2 days of proceedings, October 27 and 
28, before the FDA may be entered into this record as perhaps 
the comments provided to the FDA on its electronic docket.
    Mr. Burgess. Without objection, so ordered.
    Mr. Kerwin. The conclusion is that we think if this was a 
significant problem, we would have heard the hospitals 
clamoring. At a time of rising healthcare costs and the demand 
for smart regulation, adding to the regulatory burden, which 
only serves to burden the small business, this is troubling and 
shouldn't be supported. This is an opportunity for industry 
collaboration, especially as independents do not always receive 
the passwords, the equipment manuals, and training from the 
original equipment manufacturer at reasonable cost. It is truly 
a time together to work for patient safety. Thank you.
    [The prepared statement of Mr. Kerwin follows:]
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    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes Ms. Shrader 5 minutes for your opening 
statement, please.

                 STATEMENT OF PATRICIA SHRADER

    Ms. Shrader. Thank you, Chairman Burgess, Ranking Member 
Green, and members of the committee, for the opportunity to 
testify today.
    My name is Pat Shrader. I am the Vice President for global 
regulatory affairs at Medtronic.
    Today, I am pleased to testify on behalf of AdvaMed, the 
Advanced Medical Technology Association. We believe we are on 
the right track with FDA's device center and that recent 
progress, combined with the provisions of the new user fee 
agreement, promise to keep things heading in the right 
direction to strengthen the med tech innovation ecosystem. We 
appreciate this committee's commitment to reauthorizing this 
important program, and we urge Congress to act as a whole to 
promptly reauthorize the Medical Device User Fee Program.
    We also appreciate the committee's work in holding this 
hearing to consider additional measures that would improve the 
regulation of medical devices by advancing commonsense policies 
that will continue to improve the agency's operation.
    We are speaking today in strong support of H.R. 1736, 
introduced by Representatives Bucshon, Peters, Brooks, and 
Butterfield, to improve the medical device inspections process. 
The current inspection process is plagued by challenges that 
lead to significant inefficiencies for both manufacturers and 
the FDA. There are great discrepancies in inspections between 
facilities in the U.S. as well as between facilities of the 
same company within the U.S. and outside. These discrepancies 
result in facilities being held to different standards.
    I do want to be clear about the next point. H.R. 1736 does 
not in any way limit or restrict FDA's authority to inspect 
medical device facilities at any time.
    Medtronic, like other companies in our industry, 
understands the robust FDA inspections serve an important 
oversight function to ensure the public that we are succeeding 
in producing safe and high-quality medical devices.
    What H.R. 1736 will do is improve the device inspection 
process to increase consistency, predictability, and 
transparency and to ensure that both FDA and industry resources 
are best targeted to public health needs.
    H.R. 1736 has three main provisions: First, it establishes 
a risk-based inspection schedule for device facilities based on 
the risk profile of the facility. This commonsense shift to the 
risk-based approach to device inspections would ensure that FDA 
is inspecting where the risk to patients is greatest and is not 
utilizing important resources to repeatedly inspect facilities 
with good compliance profiles.
    Second, the bill proposes standardized and enhanced 
processes including communications between FDA and the facility 
prior to, during, and after inspections. It is important to 
note that standardizing processes and enhancing communications 
have played a key role in the improvements in the premarket 
review process leading to reduced review times. These will have 
a similar impact on FDA inspections. Timely communication can 
also help speed corrective action by companies being inspected 
where a correction is needed.
    The last provision of the bill involves the lack of 
transparency that currently exists in the export certification 
process. In order to market medical devices in many countries, 
there is a requirement for documentation that devices are 
legally marketed in the U.S. and are in compliance with U.S. 
law. This documentation is called a certificate to foreign 
governments, or CFG. Due to an unclear interaction between 
FDA's inspection process and the CFG process, device companies 
can be caught in bureaucratic red tape that results in devices 
being lawfully marketed in the U.S. being denied certification 
for marketing in other countries. Clarifying this process would 
enable device manufacturers to continue to market our products 
to other parts of the world, thus strengthening our economy.
    Again, we strongly support 1736 and urge the committee to 
pass this important legislation. I would like to note that we 
support a number of the other proposals that we believe would 
help improve the medical device regulatory process: H.R. 2144, 
which builds on 21st Century Cures to provide a streamlined 
procedural mechanism for reclassification of device 
accessories. We support 2118, an important step to assure that 
FDA has visibility into third-party servicing companies to 
ensure that devices in service remain safe and effective in 
use. And, finally, I would note that several AdvaMed member 
companies also support H.R. 2009.
    In conclusion, I appreciate the committee's work in 
considering these measures that enhance and complement the 
underlying user fee agreement to improve the regulation of 
medical devices. We look forward to continuing to work with you 
on these important issues and on timely reauthorization of the 
user fee program. Thank you.
    [The prepared statement of Ms. Shrader follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Burgess. The chair thanks the gentlelady and all of our 
witnesses for their testimony today.
    We will go to the question portion of the hearing. And I 
will recognize the gentleman from Illinois 5 minutes for 
questions, please.
    Mr. Shimkus. Thank you, Mr. Chairman.
    Just two questions. This one goes to Mr. Robinson, Mr. 
Kerwin. Obviously, there is a dispute here and which might 
likely cause this bill not to be included unless you all get 
together and work something out that seems to be helpful.
    These people who repair the equipment are trained how, Mr. 
Robinson?
    Mr. Robinson. As an OEM, we have--and I can speak for 
Philips in my case--we have Philips supply training, you know, 
based on factory protocols and engineers and----
    Mr. Shimkus. So, if there is an independent person, they 
still have to be trained by you on your equipment. Is that 
correct?
    Mr. Robinson. We offer training--and, again, I am speaking 
for Philips----
    Mr. Shimkus. That is fine. I am assuming most people are 
probably going to be similar.
    Mr. Robinson. There are certain types of training that we 
offer to third parties as well.
    I would also add that Philips and all the member companies, 
as Mr. Kerwin had mentioned as well, we leverage and utilize 
third-party service a lot ourselves and, in many cases, are 
third-party servicers----
    Mr. Shimkus. Right.
    Mr. Robinson [continuing]. Of other folk's equipment. So we 
actually have to send people for training on other equipment as 
well and organizations that do that.
    Mr. Shimkus. Right.
    Mr. Kerwin.
    Mr. Kerwin. Congressman, many times, however, the equipment 
manufacturer, if you don't have a contractual relationship with 
them, will withhold the training. And we are always concerned 
about this because, from time to time, they will cite uneven 
levels of performance, and, yet, when we ask to have members 
trained, unless you have a contractual relationship, more often 
than not it is declined. I look at it by the football analogy 
of knocking someone down on the field with a hard hit and then 
claiming later there might be a delay of game.
    Mr. Shimkus. Well, this is a very similar debate that we 
have had in this committee to the automobile manufacturers and 
the independent repair folks who always there is a debate about 
getting the data, being able to hook up to the computer module 
or also what type of equipment to replace. So it seems like the 
similar type of dispute that we have had.
    And I guess I would just say there are--also, part of the 
discussion was cost incurred to--and I said is this in my 
opening--in the opening round of questions, the projected costs 
incurred to small, rural, or regional hospitals. So, Mr. 
Robinson, do you accept that as part of the concern?
    Mr. Robinson. First of all, I want to be clear. What we are 
requesting here is the registration and a complaint system. 
That is it. That is the request----
    Mr. Shimkus. But Mr. Kerwin said there would be--every 
repair, visit, would require additional--a filing of what 
occurred. Is that correct?
    Mr. Robinson. I don't think that is the case for a 
complaint filing. You file a complaint when there is a problem 
or an adverse event. That is when that occurs.
    Now, what they would incur, as I think Dr. Shuren implied, 
under the current regulation, there is a registration fee to 
register with the FDA. I am not sure of the exact amount of 
fee. I think it is a few thousand dollars. It would be required 
by everybody who registers, but I think it would also be in the 
discretion of the FDA if they wanted to waive that fee as a 
point if that were burdensome to the small business. But that 
is not our request.
    Mr. Shimkus. I am going to stop on this. I am going to just 
for the hearing aid debate, and I think it is just helpful 
because a lot of us aren't practitioners in the field. So 
hearing loss is classified in mild, moderate, moderately 
severe, severe, profound, and deaf. Is that correct?
    So the only dispute that you all have is between mild and 
moderate while we still have moderately severe, severe, 
profound, and deaf. Is that correct?
    Mr. Powers. Yes. I would agree. I think that there is also 
a small difference in defining mild, moderate, and then 
moderately severe, how many categories you really have, and 
where does it extend? I think the concern comes from the 
current definition used within FDA, up to 720 dB hearing loss, 
which is a significant hearing loss, and those folks in many 
cases may require the services of a professional. So our view 
is that the mild hearing loss is certainly one that should be 
promoted through the OTC category for the vast majority of 
people have mild hearing loss and would benefit the most from.
    Mr. Shimkus. And Dr. Lin, in your testimony, you think that 
OTC could also comply with the moderate hearing loss?
    Dr. Lin. Yes, absolutely. From the clinical perspective, 
mild to moderate is on a natural continuum. There are no sharp 
barriers. We see right now moderate hearing loss affects about 
30 percent of everyone with a hearing loss. So you are talking 
about cutting out 30 percent of the marketplace, and consumers 
could benefit from the mild to moderate. But from a clinical 
perspective, there is no such thing right now as a hearing aid 
only for mild hearing loss or hearing only for moderate hearing 
loss. Right now, it is the same thing, basically. So, by trying 
to limit to mild hearing loss, we are essentially limiting the 
functionality of that hearing at eventually to 30 percent of 
the people with hearing loss out there, saying, ``I am sorry, 
but you will have to go through the standard channels and pay 
$4,500.''
    More from a research perspective, the best clinical trial 
to date funded by the NIH, completely independent academic 
medical center, demonstrably showed that treatment of mild to 
moderate hearing loss with over-the-counter hearing aids is 
effective. So that is a scientific perspective.
    Now, more important, I think from a larger perspective, I 
think it is easy to frame this as an either/or. You have to 
either get an over-the-counter hearing aid, or you have to go 
see a clinician. There is nothing in between. It is just not 
true. It is a very much an ``and'' phenomenon.
    And already what we are seeing right now with availability 
of and more attention paid to over-the-counter devices is that 
more patients are coming to my clinic now and seeing my 
colleagues saying, ``I have heard of this an over-the-counter 
device. Would this be relevant for me? Could I use this?'' So, 
in many cases, you may have someone with a moderate hearing 
loss. They try a device. They think it works. It may not be 
great. It drives them to see the clinician. The clinician can 
help them. It is not an either/or phenomenon.
    By limiting it to mild hearing loss, that means when a 
patient goes to see, let's say, an audiologist, then the 
audiologist can't even help them anymore with the over-the-
counter device because there is a cap placed on how much 
benefit could be obtained from it. It comes under safety, and 
it comes under efficacy. I think both have already been well 
established both clinically. I think it is a testament to the 
American Doctors of Audiology, the leading audiology group for 
private practice audiologists, already coming on full support 
of this as well as multiple medical organizations.
    Mr. Shimkus. Excellent. Thank you.
    I yield back.
    Mr. Burgess. The chair thanks the gentleman. The gentleman 
yields back.
    The chair recognizes the gentleman from Texas, Mr. Green, 5 
minutes of questions, please.
    Mr. Green. Thank you, Mr. Chairman.
    And, Dr. Lin, I know you have been involved in research 
that led to recommendations by two expert committees, both of 
which concluded that the creation of an FDA regulatory 
classification for OTC hearing aids would benefit the public. 
Can you elaborate on this work? I think you did that in your 
testimony and some other--it would help, obviously, for the 
cost, but it also may drive people to a professional because 
they find out that the over-the-counter may not work. It is 
like my colleague's reading glasses that he bought at the 
drugstore.
    Dr. Lin. Yes. So very much I think that is the case, 
Representative Green. I think what we are seeing right now is 
already, with increased attention paid to hearing loss over-
the-counter devices, it is driving people to ask about their 
hearing, to come in to get evaluated, and then they may still 
go and get an over-the-counter device, but a lot of times under 
the guidance or advice.
    I think the tendency is to think, well, if you have an 
over-the-counter device, all of the sudden, people are going to 
want to avoid doctors; they are going to want to avoid 
audiologists. It is exactly the opposite. As we have a regular 
over-the-counter category, which is broadly applicable to the 
vast majority of Americans with hearing loss, it drives someone 
to ask more questions about hearing loss. It drives more people 
to go to their physicians and say, ``I have heard these devices 
are available. Would you help me decide?'' It is a very much 
the opposite, I think, in terms of what would actually be 
projected to happen by some people in the industry.
    Mr. Green. Thank you.
    Mr. Robinson, we know certain types of medical devices and 
types of technology often require servicing and maintenance and 
repair. Hospitals and health systems have a right to rely on 
any of the original or a third-party service entity to fulfill 
that maintenance decision. The bill that we are considering 
today, H.R. 2118, would require third-party service entities to 
register and report certain adverse events and malfunctions to 
the FDA.
    In your understanding, is that all this bill does?
    Mr. Robinson. Yes. That is all this bill does. And the 
other thing I would point out: it excludes hospital-owned in-
house service----
    Mr. Green. So if you are an employee of the hospital, you 
know where the responsibility is?
    Mr. Robinson. Right. Exactly.
    Mr. Green. Can you discuss briefly why you feel legislation 
in this area is needed and the types of issues associated with 
third-party servicing that your company is aware of?
    Mr. Robinson. Can you repeat the question, sir?
    Mr. Green. Since you support the legislation, what types of 
issues associated with third-party servicing that your company 
has become aware of?
    Mr. Robinson. Oh. Well, as MITA, we submitted a big 
document of a number of adverse events that have been 
documented by member companies when they have been encountered 
and not being serviced by them. There are over 30 examples that 
are in there.
    In terms of complaints in general or adverse effects in 
general, I know the ECRI study claims that there is nothing 
wrong here; so why should we do anything? There is nobody 
reporting. So what I would suggest is maybe a good place to 
look is the FDA's own database around adverse complaints that 
are reported by the manufacturers who are required to do that.
    Mr. Green. Under current law, the FDA rules and regulations 
are on manufacturers that perform servicing are required to 
comply with it. And what FDA rules and regulations are third-
party service entities required to comply with?
    Mr. Robinson. None that I am aware of.
    Mr. Green. OK. In your opinion, does H.R. 2118 help to 
address the service issues witnessed by your company?
    Mr. Robinson. Yes. I think it would help. I think it would 
help the industry in general and the FDA as you work and track 
complaints.
    You know, as an example, if we have a piece of equipment, 
whether it is Philips or General Electric, any member company, 
and it is not being serviced by us and there have been a number 
of issues that occur that become redundant and common that we 
are not seeing, we don't know to address them. You know, so a 
common complaint handling system would escalate and elevate 
that.
    Mr. Green. Under current law, what FDA regulations are the 
manufacturers that perform servicing required to comply with?
    Mr. Robinson. I can't cite the exact law, but there is one, 
and we are all required to have quality management systems. And 
they are inspected and audited on--I think it is a biannual 
basis. And we report proactively, complaint handling system 
that rolls up.
    Mr. Green. Thank you, Mr. Chairman. I have run out of time 
unless you want to give me 5 minutes more.
    Mr. Burgess. No. That would be a no. The chair thanks the 
gentleman. The gentleman does yield back.
    The chair recognizes the gentlelady from Tennessee 5 
minutes for questions, please.
    Mrs. Blackburn. Thank you, Mr. Chairman.
    And thank you to each of you for being here today. I am 
happy to see so much love and support for over-the-counter 
hearing aids. We appreciate that.
    Mr. Robinson, I thank you that you have come in line saying 
you even support, even though----
    Mr. Robinson. I have aged in-laws that suffer with this.
    Mrs. Blackburn. You can relate to the story of----
    Mr. Robinson. I can relate to the story.
    Mrs. Blackburn. Yes, absolutely.
    Ms. Shrader, we thank you for your presence in Tennessee. 
We appreciate that Medtronic is one of our companies there and 
your presence in Memphis, and that one out of every four jobs 
in Memphis, Tennessee, is a medical-device-related job. So we 
appreciate that presence.
    Dr. Lin, I think that you have pretty much stated why this 
is important having the over-the-counter hearing aids, and I 
appreciate that.
    Let's look for just a minute, though. One more thing I want 
to touch on very quickly, state laws and why we may need to 
preempt those state laws as we look at the availability, 
especially in underserved areas. So just a couple of seconds on 
that, and then, after he finishes, Mr. Chairman, I will yield 
back.
    Dr. Lin. Thank you, Representative Blackburn. Right now as 
the act you help coauthor clearly states, there is a very 
narrow preemption of state law specifically for this over-the-
counter class of hearing aids. And this follows in line with 
what the National Academies and PCAST recommended, is we want 
to make these devices broadly available to 38 million Americans 
with hearing loss. We don't want some states saying, ``Well, 
this can't be given over the counter.'' So it does call for a 
very, very narrow preemption only for this one specific class 
of hearing aids.
    Right now, all States have on their books that hearing aids 
cannot be sold over the counter, and those regulations evolved 
40 years ago when the hearing aids back then could not be 
safely given over the counter. But clearly now, with the 
purpose of this act, it would create a narrow regulatory 
classification for a safe and effective hearing aid that could 
be given over the counter and, hence, the need for a very 
narrow limited set of state preemption for this.
    Mrs. Blackburn. I appreciate it.
    I yield back.
    Mr. Burgess. The chair thanks the gentlelady. The 
gentlelady yields back.
    The chair now recognizes the gentleman from North Carolina, 
Mr. Butterfield, for 5 minutes of questions, please.
    Mr. Butterfield. Thank you very much, Chairman Burgess. 
Thank you for holding this hearing today and including H.R. 
1736 in the list of bills that we are considering today. I am 
proud of bipartisan legislation that I introduced with my 
friends and colleagues, Dr. Bucshon, Mrs. Brooks, and Mr. 
Peters. This bipartisan legislation will improve patient safety 
by ensuring that the FDA is making the best use of its 
inspection resources. And so this may be the beginning of more 
bipartisanship in this Congress, and that is a good thing.
    This legislation, Mr. Chairman, will provide much-needed 
consistency and transparency in the routine inspections process 
by establishing rules of the road--rules of road for FDA 
inspectors, including inspecting device facilities and regular 
communications between FDA inspectors and the facility both 
before and during and after the inspection.
    Importantly, nothing in this bill takes away or limits the 
FDA's ability to inspect. It directs the FDA to focus its 
inspection resources on the more significant risk to public 
health.
    My clock is not running, Mr. Chairman. Thank you. You must 
have known I had a birthday last week.
    Mr. Burgess. The gentleman's time has expired.
    Mr. Butterfield. No. I am just going to have one or two 
questions momentarily. I won't take up the full time. I am 
proud to work with my colleagues and thank the witnesses for 
their testimony.
    Ms. Shrader, I will just do one or two questions with you 
and call it a day. I have heard from other companies based in 
North Carolina that, when FDA comes to inspect a facility, it 
is an all-hands-on-deck situation and that, with FDA inspectors 
coming and going with no regular schedule, not communicating to 
the facility when they will be back, it creates a problem.
    Can you speak to that, please?
    Ms. Shrader. Certainly. And thanks for the question. You 
described very well what happens in some of the less pleasant 
FDA inspections where we can't be sure from day to day whether 
the investigator or investigators will be on the premises or 
not, and where they are not willing to share their concerns 
with us.
    As you mentioned, we can have 100 people on call for an FDA 
inspection in order to answer all the questions that might be 
asked with the appropriate level of expertise, pull documents, 
make copies, et cetera, to ensure that the inspection goes very 
smoothly.
    Obviously, when the investigators are willing to share 
concerns with us, we can have a discussion about those concerns 
and, in many cases, we can take immediate corrective action.
    Mr. Butterfield. That leads me into my next question----
    Ms. Shrader. OK.
    Mr. Butterfield [continuing]. About the timeframe. What 
happens when an FDA inspector does find a shortcoming during 
the inspection that a company needs to address? Is there a 
timeframe that companies are required to get their correction 
back to the FDA?
    Ms. Shrader. By FDA policy, we typically have 15 days from 
the end of the inspection until a written response to any 
inspection or observations is required.
    If we don't respond within that period of time, we are at 
risk of receiving a warning letter from FDA. At the same time, 
I would note that there is no specified period of time for FDA 
to review our response and give us feedback if they feel that 
the response hasn't been adequate.
    Mr. Butterfield. I know this is time-consuming for the 
companies, but are there costs associated with waiting for FDA 
to get back with their decision, financial costs?
    Ms. Shrader. Yes, there certainly are. Of course, the cost 
of delay translates into, perhaps, manufacturing delays while 
we wait to hear whether----
    Mr. Butterfield. It is the uncertainty. It is the 
uncertainty. Am I right about it?
    Ms. Shrader. Right. Exactly.
    Mr. Butterfield. Thank you, Mr. Chairman. As promised, I 
yield back.
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes the gentleman from Indiana, Mr. 
Bucshon, for questions, please.
    Mr. Bucshon. Thank you, Mr. Chairman.
    Mr. Robinson, I have a question for you. Wouldn't you agree 
that it would be imperative that whoever is servicing or 
maintaining medical equipment must have access to the 
materials, tools, and support necessary to properly service and 
maintain the equipment in accordance with state and federal 
law? That would seem like that----
    Mr. Robinson. Yes. And we do that today.
    Mr. Bucshon. So if you have equipment that is serviced by a 
third party and they need information, you provide that?
    Mr. Robinson. We supply information to the owner of the 
equipment. So it can be a hospital, a doctor's office, whoever.
    Mr. Bucshon. OK. So then they would be able to through 
that----
    Mr. Robinson. And they would access it.
    Mr. Bucshon. Do you think that is an industrywide approach? 
Do you know?
    Mr. Robinson. I think so. I think that that is the common 
practice.
    Actually, Bob, you might know better than me if that is a 
common practice.
    Mr. Bucshon. Mr. Kerwin, you can comment on that.
    Mr. Kerwin. We have approached the FDA many times over the 
years because, sadly, it is not a common practice. Though we 
believe, since 1973, there have been regulations in place, 
which require delivery of the AIAT and other information, sir.
    Mr. Robinson. So we are required by law, and as Philips, we 
fulfill the requirement.
    Mr. Bucshon. Yes. Because it would seem to me, if a 
hospital or third-party provider under a contractual 
relationship agreed to protect their proprietary information, 
for example, which there is proprietary information on these 
products and/or pay for it, there shouldn't be any reason why 
they shouldn't be able to get that information?
    Mr. Robinson. Yes.
    Mr. Bucshon. Great. Thank you.
    Ms. Shrader, first of all, thank you for your support of 
the legislation, and I think you pretty much answered the 
question with some of your comments, 1736. But just to further 
clarify, it sounds like that you feel and your company feels 
that it would provide meaningful improvement to the FDA 
inspections with less delay to do it that way?
    Ms. Shrader. That is correct, yes.
    Mr. Bucshon. Yes. And Dr. Shuren pretty much talked about 
how the vast numbers of inspections--I think 25,000 a year or 
something in that area--and, hence, the reason we put together 
this bipartisan legislation, because we want them to be able to 
focus on areas where it is most needed and people that have 
been in long-term compliance not to be as much of the focus. So 
I appreciate your support.
    And, Mr. Chairman, I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from Massachusetts, Mr. 
Kennedy, for 5 minutes of questions.
    Mr. Kennedy. Thank you, Mr. Chairman.
    Dr. Lin, thank you for your testimony and your advocacy on 
behalf of hearing health. Thank you for some of the questions 
that you answered earlier with regards to H.R. 1652.
    I want to flesh out a little bit, in your testimony you 
talked to this, and I know there is some questions about it too 
about the value of crafting that legislation from mild and 
moderate hearing loss versus just mild hearing loss. I was 
hoping that you could just flesh out for me the medical 
difference between mild and moderate in terms of the causes and 
in terms of treatment to start.
    Dr. Lin. So, from a clinical medical perspective, there is 
no difference. It is on a natural continuum. People progress 
from mild to moderate. That currently encompasses, again, about 
95 percent of people with hearing loss have a range from mild 
to moderate. From a clinical perspective now, when you see an 
audiologist, they don't necessarily distinguish a different 
device for mild versus moderate. It is the same device; you 
just program it a little differently. That was very much the 
basis for the National Academies' recommendations that I served 
on as well as PCAST, recognizing there is a broad base of 
hearing loss that is very much treated the same way, and, 
hence, if we can have devices that are over the counter that 
are safe and effective for that broad range, why are we 
purposely handicapping it? So we say 30 percent of the people 
with hearing loss, they have to go through the traditional 
model. I think it is a little paternalistic from a medical 
point of view to say that.
    Now, I think importantly too, as I mentioned before, it is 
not an either/or phenomenon. Already what we are seeing is 
people who have access or learn about over-the-counter devices 
are coming to the physician a lot of times asking, you know, 
``What I should I do? What should I get?'' So, in many cases, 
you can imagine--and I think this is where the American Doctors 
of Audiology sees this going--is it is just another avenue of a 
way to help patients that come to see you, is that I can 
recommend to you my services. I can recommend to you a custom-
fitted, super customized hearing aid, or I can help you use an 
over-the-counter hearing aid. So to purposely limit it to a 
mild hearing loss only handicaps the clinicians who are out 
there to help the patients, basically, and, hence, a broad need 
to address mild-to-moderate in this classification.
    Mr. Kennedy. And why would not requiring for a professional 
visit be safe for those with mild loss but unsafe for those 
with moderate loss?
    Dr. Lin. I can think of none. From a medical and surgical 
standpoint, there is no distinction between the two. If it is 
safe for mild, it would be safe for moderate too as well as 
effective. I think as you go to more severe forms of moderate 
hearing loss, it is not that it becomes not effective. It 
gradually diminishes. You might need more assistance. But, 
again, this is why it is not an either/or phenomenon. That is 
when you would go see a clinician, and they could help you use 
that over-the-counter device, help you program it to adapt it 
to your lifestyle.
    Mr. Kennedy. Great.
    Mr. Chairman, I also ask unanimous consent to submit two 
studies for the record: one from the National Academies of 
Sciences, Engineering, and Medicine, and the other, as 
referenced by the witness, the President's Council of Advisors 
in Science and Technology, both studies.
    Mr. Burgess. Without objection, so ordered.
    Mr. Kennedy. Thank you. And I yield back.
    Mr. Burgess. The gentleman yields back. The chair thanks 
the gentleman.
    The chair recognizes the gentleman from New York, Mr. 
Engel, 5 minutes for questions.
    Mr. Engel. Thank you very much, Mr. Chairman.
    And thanks to our witnesses for being here and sharing your 
expertise.
    At some point or another, every one of us is going to use a 
medical device without even realizing it. I keep getting asked 
when I go through to take an airplane trip, if I have any 
medical devices on me. I guess it is with age that comes along.
    But some need devices to go about their daily activities 
more comfortably, and some may depend on one for their very 
survival; therefore, we all have a stake in the issue. And it 
is important, of course, that we assure medical devices are 
effective, safe, and readily accessible to those who need them. 
And I think that is a principle that we can agree on.
    Let me ask you, Dr. Lin. I have a few questions for you. 
During your testimony, you mentioned some of the concerns that 
have been raised with respect to over-the-counter hearing aids. 
You also noted that less than one-fifth of the nearly 38 
million Americans with substantial hearing loss presently have 
access to hearing aids. Could you elaborate, please, on how the 
potential risks of over-the-counter hearing aids stack up in 
comparison to the risks of unaddressed hearing loss?
    Dr. Lin. So I think that is exactly the question. I think 
anything we ever do policywise is a balance of benefits versus 
risks. And I think the benefits here now, now that we know from 
research that hearing loss is linked with things like dementia, 
higher healthcare costs, falls, is that anything we can do to 
address hearing loss to increase usage could only benefit 
public health. So those are clear, tangible, real benefits for 
our parents, for our seniors, for society right now.
    The risks, on the other hand, I would say are minute. When 
you talk about hearing loss in older adults, two out of every 
three adults over 70 have a hearing loss. As FDA described 
before, again, not every person needs to be medically 
evaluated. The vast majority of hearing loss that is of a 
``dangerous nature'' from a surgical perspective, things like 
cholesteatoma, tumors, things like that, invariably in almost 
all cases have warning signs--either it is only a unilateral 
hearing loss, not in both ears, it is one hearing in the ear, 
you have pain, you have drainage, you have dizziness, you have 
vertigo--all of which would be clearly labeled at the outset in 
the labeling of these devices.
    So I think the minute chances of an undetected condition 
that do have not presenting symptoms are very, very, very small 
and clearly outweighed by several orders of magnitude of the 
benefits of allowing the 80 percent of people who do not have 
hearing treatment now to get some form of help.
    Mr. Engel. Dr. Lin, late last year, FDA actually signaled 
that it might create a category of over-the-counter hearing 
aids. And, similarly, I understand that FDA released guidance 
in December outlying its decision not to enforce a requirement 
that adults undergo a doctor's exam or sign a waiver for 
purchasing hearing aids. As an expert in hearing loss and as a 
medical professional, do you feel these are sound decisions on 
the part of FDA?
    Dr. Lin. I am sorry. The last one? Do I agree with these 
decisions?
    Mr. Engel. Yes.
    Dr. Lin. Yes. No, I fully agree, and that is coming from my 
perspective as having served on the National Academies, 
advising PCAST, as well as my own role of, again, 
otolaryngologist and otologist at an academic medical center.
    Mr. Engel. Thank you. And, finally, how does this bill 
affect consumer protections regarding the safety and 
effectiveness of hearing aids? And by that, in your 
professional opinion, is there any reason to believe that 
consumers would be less safe as a result of legislation before 
us today?
    Dr. Lin. No. And I think, as I mentioned before, I think 
they are actually far safer in fact. I think the reason why 
that is, is because, as you have an over-the-counter regulated 
class that is broadly applicable to the 95 percent of people 
with hearing loss out there, it drives interest and it drives 
questions. It causes consumers and patients to ask more about 
hearing loss, to ask their physicians about hearing loss, to go 
see an audiologist to get their advice. It doesn't drive people 
away from hearing care; it drives people toward hearing care by 
offering them an avenue that they can now approach on their own 
terms.
    Mr. Engel. Thank you very much.
    I yield back.
    Mr. Burgess. The chair thanks the gentleman.
    The chair recognizes himself for 5 minutes for questions.
    Dr. Lin, I really do appreciate your testimony and your 
forthright answers to all the questions. Just so I am clear on 
this, are there any illnesses that would present with mild 
hearing loss that would be different from illnesses that would 
present with moderate hearing loss?
    Dr. Lin. No, absolutely not. From the clinical and medical 
perspective, it is on a natural continuum from one to another. 
There is no difference between the two in terms of how 
necessarily manage it with existing devices.
    Mr. Burgess. And I thank you for your written testimony. 
You actually addressed some of the concerns I had about 
children and the screening tests done at birth and the school 
testing done. In your opinion, is that going to be an adequate 
catchment for those individuals?
    Dr. Lin. Absolutely. Fortunately, the way we manage 
pediatric care in most of this country is actually very well 
done. We have universal newborn screening. Every state has some 
degree of school-based screening. If you are low income, 
Medicaid in all 50 states covers hearing aids and services for 
children. So the medical system for hearing loss and kids is 
completely different in many ways, fortunately. So I do not see 
virtually any risk of these being inadvertently or improperly 
used in children. There is no reason to.
    Mr. Burgess. Very well.
    Mr. Kerwin, Mr. Robinson, I want to talk about the devices. 
Mr. Robinson, someone mentioned about anecdotes. I think we 
have established in this committee that the plural of anecdote 
is not data. But, nevertheless, you had the plural of anecdote 
in your testimony.
    When I first started looking through that, I thought, the 
world isn't like that. And then I looked at some of the 
examples and saw tape on the equipment, and I thought, oh, that 
totally happens. You see that, unfortunately, all the time.
    So I guess, Mr. Kerwin, you said there is no evidence to 
support a problem with the servicing of medical equipment. Mr. 
Robinson has provided some compelling visual data that suggests 
otherwise.
    Shouldn't each entity that is hired to fix or refurbish 
equipment be equally responsible for documenting and submitting 
adverse-related problems that may be connected to their work?
    Mr. Kerwin, that is to you.
    Mr. Kerwin. Mr. Chairman, I believe that we are 
responsible. Our members, we have contractual obligations to 
the hospital. The hospitals have the ability to vote with their 
feet if we do not satisfy those obligations, notwithstanding we 
have long-term relationships. We voluntarily report adverse 
events. And in the ECRI study that Mr. Robinson referred to, 
they had analyzed 137,000 MAUDE reports, and there was only a 
total of 0.1 percent of total events: 241 incidents in the ECRI 
study. And I recognize that was a little while ago.
    But we say, Mr. Chairman, that the enormous amount of 
resources that would be dedicated toward reporting for, 
perhaps, 0.1 percent of total events, when it will create a sea 
change in the manner in which the rural and regional hospitals 
deal with the independents, and we feel, on balance, we do 
report, and we do have energetic internal trade association 
programs on medical devices, on adverse events, on UDI, on best 
practices for all of the events. And we recognize patient 
safety is our paramount interest.
    Mr. Burgess. Just so I am clear, Mr. Robinson, for the 
original equipment manufacturer, are you required to report 
adverse events to the Food and Drug Administration?
    Mr. Robinson. We are required. And if volunteer were good 
enough, maybe we should request the FDA to make it all 
voluntary, but I don't think there would be an interest in 
doing that.
    Mr. Burgess. And I was going to say that there are probably 
not many constituents clamoring for that. So I guess that is a 
question that I have at the end of this lengthy hearing. And, 
again, I do appreciate all of you putting so much time in with 
us today. If you are each doing the same servicing work, why 
the different treatment by the Food and Drug Administration?
    Mr. Robinson. I couldn't answer that for you. And I think, 
actually, Dr. Shuren had made a reference to there were some 
guidelines in place that there was, I think his words were, 
``lacks enforcement of.'' So there seems to be something in 
place, but there is not a requirement to implement it. That is 
my take from his comment, but I am not 100 percent sure.
    Mr. Burgess. Mr. Kerwin, you look like you wanted to say 
something.
    Mr. Kerwin. Mr. Chairman, this was examined 20 years ago. 
And, again, it is being examined today. And during this entire 
time of 20 years, we have not heard of the reporting of adverse 
events or the underreporting of adverse events. I understood 
that Dr. Shuren was referring to laparoscopic issues, and I had 
seen some publications relative to this. I have not heard, with 
respect to diagnostic imaging, anything of this nature. And it 
would seem that if we had followed the report from ECR, that if 
we are looking at a total of 0.1 percent of total events, is it 
really, in our era of having smart regulation, appropriate to 
now create a change in the manner in which all of these 
hospitals, particularly these rural hospitals, do business?
    Mr. Robinson. The good news is there is no new regulation. 
We are simply asking for the distribution of the existing 
regulation to the independent services.
    Mr. Burgess. And I appreciate that it is infrequent, but we 
know, as you look at some of these pictures that were provided 
to us, would I want a family member to be utilizing that 
equipment----
    Mr. Robinson. I would not.
    Mr. Burgess [continuing]. Would I be perfectly comfortable 
with, honestly, some of it is quite sophisticated, like the 
cooling mechanism for the magnet in an MRI, but some of it is 
fairly mundane, like cracks in the plastic--or the rubberized 
guard on a patient mat on a gurney.
    Mr. Kerwin. Mr. Chairman, if I may speak to that?
    Mr. Burgess. Turn your mike on.
    Mr. Kerwin. Mr. Chairman----
    Mr. Burgess. Is your microphone on?
    Mr. Kerwin. My apologies.
    Mr. Burgess. Thank you.
    Mr. Kerwin. In preparation for our hearing today, we 
contemplated, would we bring our pictures? Would we show areas 
where we have taken over for the manufacturer? And I have been 
assured by several companies that, if necessary, we, too, can 
produce. But we thought the attribution to nameless 
independents paints an entire industry and perhaps unfairly. 
And we would like to focus on the collegiality.
    At one point in 1997, FDA assisted in the collaboration 
with AME and with all the stakeholders working toward an 
industry solution relative to this. Let's turn over the 
passwords, equipment manuals, and training; let's cooperate 
relative to the reporting. And, unfortunately, the person at 
AME who was coordinating much of that departed, and we did not 
reach closure. We called for a collaborative effort during the 
October 27, 28 meeting before FDA. We think this belongs with 
industry, particularly where there is no real-world evidence to 
back this up. And I still await attribution of these nameless 
independents for whom we have pictures. And if the committee 
wishes, we can bring pictures, but we don't think that is the 
ultimate solution.
    Mr. Burgess. Mr. Robinson, what about that? What about the 
sharing of data and passwords?
    Mr. Robinson. Yes, we comply with all the laws. And every 
one of the member companies, to the best of my ability, 
complies with those laws and regulations. We supply the 
servicing and preventive maintenance manuals to the owners of 
the equipment, as required.
    What I would tell you is, in general, no industry is 
perfect. The people who repair machines are people. The people 
who build machines are people. And that is why they break. And 
that is why companies like ours do service. And the OEMs, in 
terms of pictures or adverse events, are an open book. We have 
to report it to the FDA. All we are asking for is the same open 
book. Let's not have it in nameless pictures. Let's have 
everyone report the same way, and that is all we are requesting 
in this.
    Mr. Burgess. Well, obviously, that does not conclude this 
discussion, but it concludes our hearing.
    Mr. Robinson. But thank you for your time and attention.
    Mr. Kerwin. Thank you for your time.
    Mr. Burgess. Well, seeing that there are no further members 
wishing to ask questions, I do want to thank our witnesses for 
being here today.
    We have received outside feedback from a number of 
organizations on these bills. So there are statements to submit 
for the record from AARP, from the International Hearing 
Society, from the American Speech-Language-Hearing Association, 
from the Academy of Doctors of Audiology, from the American 
Academy of Otolaryngology-Head, and Neck Surgery, Consumer 
Technology Association, Aramark, Consumers Union, Repair.org.
    Without objection, so ordered. Those will be entered into 
the record.
    [The information appears at the conclusion of the hearing.]
    Mr. Burgess. Pursuant to committee rules, I remind members 
they have 10 business days to submit additional questions for 
the record.
    And I ask the witnesses to submit their responses within 10 
business days upon receipt of those questions.
    And, without objection, the subcommittee is adjourned.
    [Whereupon, at 12:39 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
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