Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
fda-device · Food and Drug Administration · Rule · Published 2022-08-17 · Effective 2022-10-17 · 87 FR 50698
Document
Document number
2022-17230
Federal Register citation
87 FR 50698
CFR reference
21 CFR 800
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2022-08-17
Effective date
2022-10-17
HHS docket
Docket No. FDA-2021-N-0555
Abstract
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 amendments 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 hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal 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.