FDA Posts Draft Guidance on Differences Between Hearing Aids, Personal Sound Amplification Products

The Food and Drug Administration posted a draft guidance on hearing aid devices and personal sound amplification products (here). Once finalized, the guidance will clarify for industry and staff the differences between hearing aids and personal sound amplification products, as well as the regulatory controls that apply to each, FDA said. Hearing aids are defined as medical devices, and are more heavily regulated by FDA than personal sound amplification products, it said. Comments on FDA’s draft guidance are due by Feb. 5.