81 FR 89469 - Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 238 (December 12, 2016)

The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids.'' FDA is issuing this guidance to communicate to consumers, hearing aid dispensers, hearing aid manufacturers, and hearing health professionals that FDA does not intend to enforce certain conditions for sale of hearing aid devices that are required per FDA regulation. Specifically, FDA does not intend to enforce the medical evaluation or recordkeeping requirements prior to the dispensing of certain hearing aid devices to individuals 18 years of age and older.

[Federal Register Volume 81, Number 238 (Monday, December 12, 2016)]
[Notices]
[Pages 89469-89470]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29724]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3466]


Immediately in Effect Guidance Document: Conditions for Sale for 
Air-Conduction Hearing Aids; Guidance for Industry and Food and Drug 
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Immediately in Effect 
Guidance Document: Conditions for Sale for Air-Conduction Hearing 
Aids.'' FDA is issuing this guidance to communicate to consumers, 
hearing aid dispensers, hearing aid manufacturers, and hearing health 
professionals that FDA does not intend to enforce certain conditions 
for sale of hearing aid devices that are required per FDA regulation. 
Specifically, FDA does not intend to enforce the medical evaluation or 
recordkeeping requirements prior to the dispensing of certain hearing 
aid devices to individuals 18 years of age and older.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-D-3466 for ``Immediately in Effect Guidance Document: 
Conditions for Sale for Air-Conduction Hearing Aids.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Immediately in Effect Guidance Document: Conditions for Sale for Air-
Conduction Hearing Aids'' to the Office of the Center Director, 
Guidance and Policy Development, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed 
adhesive label to assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Srinivas Nandkumar, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2436, Silver Spring, MD 20993-0002, 301-
796-6480.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to communicate to consumers, hearing 
aid dispensers, hearing aid manufacturers, and hearing health 
professionals that FDA does not intend to enforce certain conditions 
for sale of hearing aid devices that are required per FDA regulation. 
Specifically, FDA does not intend to enforce the medical evaluation 
(Sec.  801.421(a) (21 CFR 801.421(a)) or recordkeeping (Sec.  
801.421(d))

[[Page 89470]]

requirements prior to the dispensing of certain hearing aid devices to 
individuals 18 years of age and older.
    This guidance applies to the subset of hearing aids that are 
regulated as class I air-conduction hearing aids under Sec.  
874.3300(b)(1) (21 CFR 874.3300(b)(1)) and class II wireless air-
conduction hearing aids under Sec.  874.3305, where hearing aid means 
``any wearable instrument or device designed for, offered for the 
purpose of, or represented as aiding persons with or compensating for, 
impaired hearing,'' as defined in Sec.  801.420(a)(1). This guidance 
does not apply to class II bone-conduction hearing aids as identified 
in Sec.  874.3300(b)(2). Also, hearing aids labeled for prescription 
use only, e.g., those that are inserted deep in the ear canal by a 
hearing health professional, should continue to be sold only as 
directed.
    This guidance is being implemented without prior public comment 
because the Agency has determined that prior public participation is 
not feasible or appropriate (see section 701(h)(1)(C)(i) of the FD&C 
Act (21 U.S.C. 371(h)(1)(C)(i)) and Sec.  10.115.(g)(2) (21 CFR 
10.115(g)(2))). FDA believes that immediate implementation of the 
guidance is needed to assist in addressing a significant public health 
issue. Further, FDA has determined that this guidance document presents 
a less burdensome policy that is consistent with public health. 
Although this guidance is immediately in effect, FDA will consider all 
comments received and revise the guidance document as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (Sec.  10.115). The guidance represents the 
current thinking of FDA on conditions for sale for air-conduction 
hearing aids. It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Immediately in Effect 
Guidance Document: Conditions for Sale for Air-Conduction Hearing 
Aids'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 16041 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. 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 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; and the collections of 
information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

    Dated: December 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29724 Filed 12-9-16; 8:45 am]
 BILLING CODE 4164-01-P