[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Rules and Regulations]
[Pages 57610-57612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23464]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. FDA-2019-N-4328]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying 
the self-fitting air-conduction hearing aid into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the self-fitting air-conduction hearing aid's classification. We are 
taking this action because we have determined that classifying the 
device into class II (special controls) will provide a reasonable 
assurance of safety and effectiveness of the device. We believe this 
action will also enhance patients' access to beneficial innovative 
devices, in part by reducing regulatory burdens.

DATES: This order is effective October 28, 2019. The classification was 
applicable on October 5, 2018.

FOR FURTHER INFORMATION CONTACT: Cherish Giusto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2432, Silver Spring, MD 20993-0002, 301-796-9679, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the self-fitting air-conduction 
hearing aid as class II (special controls), which we have determined 
will provide a reasonable assurance of safety and effectiveness. In 
addition, we believe this action will enhance patients' access to 
beneficial innovation, in part by reducing regulatory burdens by 
placing the device into a lower device class than the automatic class 
III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in commercial distribution prior to the date of 
enactment of the Medical Device Amendments of 1976, which amended the 
Federal Food, Drug, and Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act to a predicate device that does not require 
premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new 
device is substantially equivalent to a predicate by means of the 
procedures for premarket notification under section 510(k) of the FD&C 
Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act (21 U.S.C. 360c(f)(2)). Section 207 of the Food and Drug 
Administration Modernization Act of 1997 established the first 
procedure for De Novo classification (Pub. L. 105-115). Section 607 of 
the Food and Drug Administration Safety and Innovation Act modified the 
De Novo application process by adding a second procedure (Pub. L. 112-
144). A device sponsor may utilize either procedure for De Novo 
classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a

[[Page 57611]]

determination of substantial equivalence, that person requests a 
classification under section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically within 
class III, the De Novo classification is considered to be the initial 
classification of the device.
    We believe this De Novo classification will enhance patients' 
access to beneficial innovation, in part by reducing regulatory 
burdens. When FDA classifies a device into class I or II via the De 
Novo process, the device can serve as a predicate for future devices of 
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a 
result, other device sponsors do not have to submit a De Novo request 
or premarket approval application in order to market a substantially 
equivalent device (see 21 U.S.C. 360c(i), defining ``substantial 
equivalence''). Instead, sponsors can use the 510(k) process, when 
necessary, to market their device.

II. De Novo Classification

    On May 11, 2018, Bose Corp. submitted a request for De Novo 
classification of the Bose Hearing Aid. FDA reviewed the request in 
order to classify the device under the criteria for classification set 
forth in section 513(a)(1) of the FD&C Act.
    We classify 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 that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on October 5, 2018, FDA issued an order to the requester 
classifying the device into class II. FDA is codifying the 
classification of the device by adding 21 CFR 874.3325. We have named 
the generic type of device self-fitting air-conduction hearing aid, and 
it is identified as a wearable sound amplifying device that is intended 
to compensate for impaired hearing and incorporates technology, 
including software, that allows users to program their hearing aids. 
This technology integrates user input with a self-fitting strategy and 
enables users to independently derive and customize their hearing aid 
fitting and settings.
    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

  Table 1--Self-Fitting Air-Conduction Hearing Aid Risks and Mitigation
                                Measures
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             Identified risks                    Mitigation measures
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Diminished hearing due to over-             Software verification,
 amplification caused by:                    validation, and hazard
 Excessively high sound output       analysis;
 levels in the ear canal                    Electroacoustic performance
 Device malfunction                  testing; and
 Interference with or from other    Electromagnetic
 devices                                     compatibility (EMC)
                                             testing.
Listening fatigue or failure to provide     Clinical data;
 sound awareness due to over- or under-     Usability testing;
 amplification caused by:                   Software verification,
 Poor fitting                        validation, and hazard
 Device malfunction                  analysis;
 Use error                          Electroacoustic performance
 Interference with or from other     testing;
 devices                                    EMC testing; and
                                            Labeling
Tissue heating due to exposure to non-      Wireless technology
 ionizing radiation emitted by wireless      evaluation; and
 technology                                 Labeling.
Tissue trauma/damage in the ear canal or    Usability testing;
 other patient contacting areas due to:     Electrical and thermal
                                             safety testing; and
                                             Labeling.
     Excessively long ear piece
     Device malfunction
     Use error
Missed or delayed medical diagnosis or      Labeling.
 treatment due to failure to self-identify
 correct population and condition
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. In order for a device to fall 
within this classification, and thus avoid automatic classification in 
class III, it would have to comply with the special controls named in 
this final order. The necessary special controls appear in the 
regulation codified by this order. This device is subject to premarket 
notification requirements under section 510(k) of the FD&C Act.

III. Analysis of 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. These collections of information are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections 
of information in the guidance document ``De Novo Classification 
Process (Evaluation of Automatic Class III Designation)'' have been 
approved under OMB control number 0910-0844; the collections of 
information in 21 CFR part 820, regarding quality system regulation, 
have been approved under OMB control number 0910-0073; the collections 
of information in 21 CFR part 814, subparts A through E, regarding

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premarket approval, have been approved under OMB control number 0910-
0231; the collections of information in part 807, subpart E, regarding 
premarket notification submissions, have been approved under OMB 
control number 0910-0120; and the collections of information in 21 CFR 
part 801, regarding labeling, have been approved under OMB control 
number 0910-0485.

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 part 874 continues to read as follows:

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


0
2. Add Sec.  874.3325 to subpart D to read as follows:


Sec.  874.3325   Self-fitting air-conduction hearing aid.

    (a) Identification. A self-fitting air-conduction hearing aid is a 
wearable sound amplifying device that is intended to compensate for 
impaired hearing and incorporates technology, including software, that 
allows users to program their hearing aids. This technology integrates 
user input with a self-fitting strategy and enables users to 
independently derive and customize their hearing aid fitting and 
settings.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) Clinical data must evaluate the effectiveness of the self-
fitting strategy.
    (2) Electroacoustic parameters, including maximum output limits, 
distortion levels, self-generated noise levels, latency, and frequency 
response, must be specified and tested.
    (3) Performance data must demonstrate the electromagnetic 
compatibility (EMC), electrical safety, and thermal safety of the 
device.
    (4) Software verification, validation, and hazard analysis must be 
performed.
    (5) If the device incorporates wireless technology:
    (i) Performance testing must validate safety of exposure to non-
ionizing radiation;
    (ii) Performance data must validate wireless technology functions; 
and
    (iii) Labeling must specify instructions, warnings, and information 
relating to wireless technology and human exposure to non-ionizing 
radiation.
    (6) Usability testing must demonstrate that users can correctly use 
the device as intended under anticipated conditions of use.
    (7) Patient labeling must include the following:
    (i) Information on how a patient can self-identify as a candidate 
for the device;
    (ii) Information about when to seek professional help;
    (iii) A warning about using hearing protection in loud 
environments;
    (iv) A warning about staying alert to sounds around the user of the 
device;
    (v) Technical information about the device, including information 
about EMC; and
    (vi) Information on how to correctly use and maintain the device.

    Dated: October 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23464 Filed 10-25-19; 8:45 am]
 BILLING CODE 4164-01-P