OTC Hearing Aid Rules Released

On Tuesday, August 16, 2022, the U.S. Food and Drug Administration (FDA) released its [final rule] regarding over-the-counter (OTC) hearing aids. The move will allow those with mild to moderate hearing loss to directly purchase hearing aids from retailers. After considering over 1,000 responses during the public comment period, the FDA decided to make changes to the original October 20, 2021, proposed rule, some of which aligned with Illinois & International's recommendations.  See Illinois' Jan 16th Letter to the FDA [here].

The final rule also includes performance specifications and device design requirements specific to OTC hearing aids. The effective date for the final rule is 60 days after the publication in the Federal Register, with FDA reporting it expects OTC hearing aids to be available as soon as mid-October. You may find more information on this topic on the International Hearing Society's Advocacy Page [here].