Over-the-Counter Hearing Aids Final Rule Released

The Food and Drug Administration (FDA) released today the final rule, “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.” The rule is available in the Federal Register, and the FDA has issued a press release. The effective date for the final rule is 60 days following publication in the Federal Register. 

The Academy’s OTC Task Force is reviewing the rule, and analysis will be forthcoming to the members through a variety of communications. Continue to check the Academy’s over-the-counter hearing aid resource page.