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HHS/FDA RIN: 0910-AI21 Publication ID: Fall 2021 
Title: Medical Devices; Ear, Nose and Throat Devices; Establishing Over-the-Counter Hearing Aids and Aligning Other Regulations 

FDA is proposing to establish an over-the-counter category of hearing aids to promote the availability of additional kinds of devices that address mild to moderate hearing loss, and proposing related amendments to the current hearing aid regulations, the regulations codifying FDA decisions on State applications for exemption from preemption, and the hearing aid classification regulations.

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 800    21 CFR 801    21 CFR 808    21 CFR 874   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331 to 334    21 U.S.C. 351 and 352    21 U.S.C. 360    21 U.S.C. 360c to 360e    Pub. L. 115-52, 131 Stat. 1065-67    21 U.S.C. 360i to 360k    21 U.S.C. 360l    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 381    ...   
Legal Deadline:
Action Source Description Date
NPRM  Statutory    08/18/2020 

Statement of Need:

Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. However, only about one-fifth of people who could benefit from a hearing aid seek intervention. Several barriers likely impede the use of hearing aids, and FDA is proposing rules to address some of these concerns.

Summary of the Legal Basis:

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) establishes a comprehensive system for the regulation of devices intended for human use, and hearing aids are subject to those provisions. Furthermore, the FDA Reauthorization Act of 2017 (Pub. L. 115-52, 131 Stat. 1005, 1066) directs FDA to establish by regulation a category of over-the-counter hearing aids. This rulemaking establishes requirements for the safe and effective use of hearing aids, including for the over-the-counter category of hearing aids.  


FDA must establish the category of over-the-counter hearing aids as well as requirements that provide for reasonable assurance of safety and effectiveness of these hearing aids. However, FDA will consider different specific options to maximize the health benefits to hearing aid users while minimizing the economic burdens of the final rules.

Anticipated Costs and Benefits:

FDA expects benefits of the rule to include cost savings to consumers who wish to buy lower-cost hearing aids, in part by enabling consumers to cross-compare and purchase the devices more easily. Other benefits may include improving health equity, especially for Americans living in rural areas, those with limited mobility, or those with limited means. Individual benefits may include improved health outcomes, and therefore improved social and economic participation. FDA expects costs to include those costs to manufacturers for changing labeling and updating existing processes.



Action Date FR Cite
NPRM  10/20/2021  86 FR 58150   
NPRM Comment Period End  01/18/2022 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: State 
Small Entities Affected: No  Federalism: Yes 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Ian Ostermiller
Regulatory Counsel, Center for Devices and Radiological Health
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 66, Room 5454,
Silver Spring, MD 20993
Phone:301 796-5678