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FDA: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids

Federal Register
Oct 20, 2021
Notice of proposed rule from the Food and Drug Administration (FDA) proposing to establish a regulatory category for over-the-counter (OTC) hearing aids to improve access to hearing aid technology for people 18 years old or older. This notice is also proposing related amendments to update the regulatory framework for hearing aids. Includes considerations for hearing aid access in rural and underserved communities. Comments on the proposed rule are due by January 18, 2022. Comments on the information collection are due by November 19, 2021.
Tagged as
Access · Hearing impairment · Legislation and regulations · Pharmacy and prescription drugs