Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
Information
Type
Rule
Regulated products
Medical Devices
Published
August 17, 2022
Last updated
August 17, 2022
Description
Document number 2022-17230. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)