Final Rule: Medical Devices; Ear, Nose & Throat Devices; Establishing Over-The-Counter Hearing Aids

On August 17, 2022 the U.S. Food and Drug Administration (FDA) published this final rule regarding medical devices, specifically ear, nose, and throat devices and establishing over-the-counter hearing aids. The Food and Drug Administration (FDA) 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, the rule defines OTC hearing aids and establish applicable requirements; amends existing rules for consistency with the new OTC category; repeals the conditions for sale applicable to hearing aids; amends the existing labeling requirements for hearing aids . . .