[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Rules and Regulations]
[Pages 34845-34847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-14790]



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  Federal Register / Vol. 76, No. 115 / Wednesday, June 15, 2011 / 
Rules and Regulations  

[[Page 34845]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2011-N-0361]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
the Wireless Air-Conduction Hearing Aid

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is classifying the 
wireless air-conduction hearing aid into class II (special controls). 
The Agency is classifying the device into class II (special controls) 
in order to provide a reasonable assurance of safety and effectiveness 
of the device.

DATES: This rule is effective July 15, 2011. The classification was 
effective on March 31, 2011.

FOR FURTHER INFORMATION CONTACT: Vasant Dasika, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, rm. 2443, Silver Spring MD 20993-0002, 301-796-5365.

SUPPLEMENTARY INFORMATION: 

I. Background

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 360c(f)(1)), devices that were not 
in commercial distribution before May 28, 1976 (the date of enactment 
of the Medical Device Amendments of 1976), generally referred to as 
postamendments devices, are classified automatically by statute into 
class III without any FDA rulemaking process. These devices remain in 
class III and require premarket approval, unless and until the device 
is classified or reclassified into class I or II, or FDA issues an 
order finding the device to be substantially equivalent, in accordance 
with section 513(i) of the FD&C Act, to a predicate device that does 
not require premarket approval. The Agency determines whether new 
devices are substantially equivalent to predicate devices by means of 
premarket notification procedures in section 510(k) of the FD&C Act (21 
U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
    Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C Act 
for a device that has not previously been classified may, within 30 
days after receiving an order classifying the device into class III 
under section 513(f)(1), request FDA to classify the device under the 
criteria set forth in section 513(a)(1). FDA will, within 60 days of 
receiving this request, classify the device by written order. This 
classification will be the initial classification of the device. Within 
30 days after the issuance of an order classifying the device, FDA must 
publish a notice in the Federal Register announcing this 
classification.
    In accordance with section 513(f)(1) of the FD&C Act, FDA issued an 
order on September 13, 2010, classifying the CLEAR 440 Series of 
hearing aids into class III, because it was not substantially 
equivalent to a device that was introduced or delivered for 
introduction into interstate commerce for commercial distribution 
before May 28, 1976, or a device that was subsequently reclassified 
into class I or class II. On October 13, 2010, Widex Hearing Aid Co. 
submitted a petition requesting classification of the CLEAR 440 Series 
of hearing aids under section 513(f)(2) of the FD&C Act. The 
manufacturer recommended that the device be classified into class II 
(Ref. 1).
    In accordance with section 513(f)(2) of the FD&C Act, FDA reviewed 
the petition in order to classify the device under the criteria for 
classification set forth in section 513(a)(1). FDA classifies devices 
into class II if general controls by themselves are insufficient to 
provide reasonable assurance of safety and effectiveness, but there is 
sufficient information to establish special controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use. After review of the information submitted in the 
petition and information submitted during interactive review, FDA 
determined that the device can be classified into class II with the 
establishment of special controls. FDA believes these special controls 
will provide reasonable assurance of the safety and effectiveness of 
the device.
    The device is assigned the generic name wireless air-conduction 
hearing aid, and it is identified as a wearable sound-amplifying 
device, intended to compensate for impaired hearing, that incorporates 
wireless technology in its programming or use.
    FDA has identified the following risks to health associated with 
this type of device and the measures required to mitigate these risks:

------------------------------------------------------------------------
             Identified risk                     Required measures
------------------------------------------------------------------------
Degradations in device function due to    Electromagnetic compatibility
 electromagnetic interference (EMI).       (EMC) testing; labeling.
Degradations in device function due to    Wireless technology design,
 wireless technology disruption such as    description, and testing;
 slow-down, lost or corrupted              performance testing;
 information, security issues including    labeling.
 potential cross-talk or control by
 other users with a similar medical
 device.
Exposure to non-ionizing radiation        Wireless technology design,
 emitted by wireless technology can        description, analysis, and
 potentially induce tissue heating.        testing; labeling.
------------------------------------------------------------------------

    FDA believes that the following special controls, in addition to 
general controls, address the risks to health and provide reasonable 
assurance of the safety and effectiveness of the device: (1) 
Appropriate analysis/testing should validate EMC and safety of exposure 
to non-ionizing radiation; (2) Design, description, and performance 
data

[[Page 34846]]

should validate wireless technology functions; and (3) Labeling should 
specify appropriate instructions, warnings, and information relating to 
EMC and wireless technology and human exposure to non-ionizing 
radiation. Therefore, on March 31, 2011, FDA issued an order to the 
petitioner classifying the device into class II. FDA is codifying the 
classification of the device by adding Sec.  874.3305.
    Following the effective date of this final classification rule, any 
firm introducing a wireless air-conduction hearing aid into interstate 
commerce in the United States will need to comply with the special 
controls named in the regulation. However, the firm need only show that 
its device meets the recommendations of the special controls or in some 
other way provides equivalent assurance of safety and effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class 
II device from the premarket notification requirements under section 
510(k) if FDA determines that premarket notification is not necessary 
to provide reasonable assurance of the safety and effectiveness of the 
device. For this type of device, FDA has determined that premarket 
notification is not necessary to provide reasonable assurance of the 
safety and effectiveness of the device. Therefore, this device type is 
exempt from premarket notification requirements.

II. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Order 12866 directs Agencies to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). The Agency 
believes that this final rule is not a significant regulatory action 
under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because reclassification of this device from class 
III to class II will relieve manufacturers of the device of the cost of 
complying with the premarket approval requirements of section 515 of 
the FD&C Act (21 U.S.C. 360e), and may permit small potential 
competitors to enter the marketplace by lowering their costs, the 
Agency certifies that the final rule will not have a significant 
economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and Tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. Section 4(a) of the Executive order 
requires Agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.'' Federal law includes an express preemption provision 
that preempts certain state requirements ``different from or in 
addition to'' certain Federal requirements applicable to devices. (See 
section 521 of the FD&C Act (21 U.S.C. 360k); See Medtronic v. Lohr, 
518 U.S. 470 (1996); Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). 
The special controls established by this final rule create 
``requirements'' for specific medical devices under 21 U.S.C. 360k, 
even though product sponsors have some flexibility in how they meet 
those requirements. (See Papike v. Tambrands, Inc., 107., 107 F.3d 737, 
740-42 (9th Cir. 1997).)

V. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no new collections of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 
3501-3520) is not required.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Widex Hearing Aid Co., dated October 13, 2010.

List of Subjects in 21 CFR Part 874

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for 21 CFR part 874 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Section Sec.  874.3305 is added to subpart D to read as follows:


Sec.  874.3305   Wireless Air-Conduction Hearing Aid.

    (a) Identification. A wireless air-conduction hearing aid is a 
wearable sound-amplifying device, intended to compensate for impaired 
hearing that incorporates wireless technology in its programming or 
use.
    (b) Classification: Class II (special controls). The special 
controls for this device are:
    (1) Appropriate analysis/testing should validate electro magnetic 
compatibility (EMC) and safety of exposure to non-ionizing radiation;
    (2) Design, description, and performance data should validate 
wireless technology functions; and
    (3) Labeling should specify appropriate instructions, warnings, and 
information relating to EMC and wireless technology and human exposure 
to non-ionizing radiation.
    (c) Premarket notification. The wireless air-conduction hearing aid 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to Sec.  874.9.


[[Page 34847]]


    Dated: June 9, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-14790 Filed 6-14-11; 8:45 am]
BILLING CODE 4160-01-P