G/TBT/N/USA/1791  
21 October 2021  
(21-7962) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  UNITED STATES OF AMERICA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Food and Drug Administration (FDA), Health and Human Services 
(HHS) [1820]  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the not ification shall be indicated if different from above:   
Please submit comments to: USA WTO TBT Enquiry Point, Email: usatbtep@nist.gov  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [X], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Hearing 
aids; Hearing aids (excl. parts and accessories) (HS 902140); Quality (ICS 03.120), Aids 
for deaf and hearing impaired people (ICS 11.180.15)  
5. Title, number of pages and language(s) of the notified document:  Medical Devices; 
Ear, Nose, and Thro at Devices; Establishing Over -the-Counter Hearing Aids (42 page(s), 
in English)  
6. Description of content:  Proposed rule - The Food and Drug Administration (FDA, we, 
or the Agency) is  proposing to establish a regulatory category for over -the-counter (OTC)  
hearing aids and to make related amendments to update the regulatory framework for 
hearing aids. Specifically, we propose to define OTC hearing aids and establish applicable 
requirements; amend existing rules for consistency with a new OTC category; repea l the 
conditions for sale applicable to hearing aids; amend the existing labeling requirements 
for hearing aids; and update regulations relating to decisions on applications for 
exemption from Federal preemption that would become obsolete as a result of ch anges 
to the hearing aid requirements. This action, if finalized, would more clearly define 
prescription hearing aids; however, it would not change the classification of existing 
device types. In creating a regulatory category for OTC hearing aids and amen ding 
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.  
7. Objective and ratio nale, including the nature of urgent problems where 
applicable:  Consumer information, labelling; Prevention of deceptive practices and 
consumer protection; Protection of human health or safety; Quality requirements  G/TBT/N/USA/1791  
 
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  8. Relevant documents:   
86 Federal Register (FR) 58150,  20 October 2021; Title  21 Code of Federal Regulations 
(CFR) Parts 800, 801, 808, and 874:  
https://www.govinfo.gov/content/pkg/FR -2021-10-20/html/2021 -22473.htm  
https://www.govinfo.gov/content/pkg/FR -2021-10-20/pdf/2021 -22473.pdf  
This proposed rule is 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. WTO Members and their stakeholders are asked to submit comments 
to the USA TBT Enquiry Point . Comments received by the USA TBT Enquiry Point from 
WTO Members and their stakeholders will be shared with the regulator and will also be 
submitted to the Docket  on Regulations.gov if received within the comment period.  
Food and Drug Administration (FDA), Health and Human Services (HHS)  Guidance: 
Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification 
Products; Notice of Availability:  
https://www.govinfo.gov/content/pkg/FR -2021-10-20/html/2021 -22612.htm   
https://www.govinfo.gov/content/pkg/FR -2021-10-20/pdf/2021 -22612.pdf  
9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  To be determined  
10. Final date for comments:  18 January 2022  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://members.wto.org/crnattachments/2021/TBT/USA/21_6684_00_e.pdf