G/TBT/N/USA/1791/Add.1  
 
23 August 2022  
(22-6359) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English  
 
 
NOTIFICATION  
Addendum  
The following communication , dated  23 August 2022, is being circulated at the request of the 
delegation of the United States of America . 
 
_______________  
 
 
Title:  Medical Devices; Ear, Nose, and Throat Devices; Establishing Over -the-Counter Hearing Aids  
 
Reason for Addendum:  
[ ] Comment period changed - date:   
[ ] Notified measure adopted - date:  
[X] Notified measure published - date: 17 August 2022  
[X] Notified measure enters into force - date: 17 October 2022  
[X] Text of final measure available from1:  
https://www.govinfo.gov/content/pkg/FR -2022-08-17/html /2022 -17230.htm  
https://www.govinfo.gov/content/pkg/FR -2022-08-17/pdf/2022 -17230.pdf  
https://members.wto.org/crnattachments/2022/TBT/USA/final_measure/22_5728_00_
e.pdf 
[ ] Notified measure withdrawn or revoked - date:  
Relevant symbol if measure re -notified:   
[ ] Content or scope of notified measure changed  and text available from1:  
New deadline for comments (if applicable):   
[ ] Interpretive guidance issued and text available from1:  
[ ] Other:  
 
Description:  TITLE: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over -the-Counter 
Hearing Aids  
AGENCY: Food and Drug Administration, Department of Health and Human Services (HHS)  
ACTION: Final rule  
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory 
category for over -the-counter (OTC) hearing aids and making related am endments to update the 
regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish 
applicable requirements; amend existing rules for consistency with the new OTC category; repeal 
the conditions for sale applicable to heari ng aids; amend the existing labeling requirements for 
hearing aids; and update regulations relating to decisions on applications for exemption from Federal 
 
1 This information can be provided by including a website address, a pdf attachment, or other 
information on where the text of the final /modified  measure and/or interpretive guidance can be obtained.  G/TBT/N/USA/1791/Add.1  
 
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  preemption that will become obsolete as a result of changes to the hearing aid requirements. In 
creating a regulatory category for OTC hearing aids and amending existing rules, we intend to 
provide reasonable assurance of safety and effectiveness for these devices as well as foster access 
to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.  
DATES: Effective date: This rule is effective 17 October 2022.  
Compliance dates: For hearing aids that have been legally offered for sale prior to 17 October 2022, 
including hearing aids that already have a 510(k) clearance , compliance with the new or revised 
requirements must be achieved by 14 April 2023. For hearing aids that have not been offered for 
sale prior to 17 October 2022, or have been offered for sale but are required to submit a new 510(k) 
due to changes unrelat ed to this rule, compliance with the new or revised requirements applicable 
to the hearing aid, and obtaining 510(k) clearance if applicable, must be achieved before marketing 
the device on or after 17 October 2022.  
Incorporation by reference: The incorpor ation by reference of certain material listed in this rule is 
approved by the Director of the Federal Register as of 17 October 2022.  
This final rule and the proposed rule notified as G/TBT/N/USA/1791  are identified by Docket Number 
FDA-2021-N-0555. The Docket Folder is available on Regulations.gov at 
https://www.regulations.gov/docket/FDA -2021-N-0555/document  and provides access to primary 
and supporting documents as well as comments received. Documents are also accessible from 
Regulations.gov  by searching the Docket Number.  
GUIDANCE DOCUMENT - Regulatory Requirements for Hearing Aid Devices and Personal Sound 
Amplification Products; Guidance for Industry and Food and Drug Administration Staff  
AUGUST 2022: https://www.fda.gov/regulatory -information/search -fda-guidance -
documents/regulatory -requirements -hearing -aid-devices -and-personal -sound -amplification -
products  
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) 
on this topic. 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. To discuss an alternative approach, contact the FDA staff or Office responsible for this 
guidance as listed on the title page at https://www.f da.gov/media/87330/download . 
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