# Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
> **Food and Drug Administration** · Final rule. · Published 2022-08-17 · Effective 2022-10-17 · 87 FR 50698
## Document
- **Document number:** 2022-17230
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 87 FR 50698
- **CFR reference:** 21 CFR 800
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids)
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