Regulatory Counsel, Center for Devices and Radiological Health

0910-AI21 202110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No 21 CFR 800 21 CFR 801 21 CFR 808 21 CFR 874 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 ... Statutory NPRM 08/18/2020 Yes

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.

]]>

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.

]]>

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.

]]>

None

]]> NPRM 10/20/2021 86 FR 58150 NPRM Comment Period End 01/18/2022 Undetermined No State Yes No No Ian Ostermiller Regulatory Counsel, Center for Devices and Radiological Health 0910 Food and Drug Administration FDA 301 796-5678 ian.ostermiller@fda.hhs.gov 10903 New Hampshire Avenue, WO 66, Room 5454, Silver Spring MD 20993