Making Hearing Aids, Or Are They PSAPs? US FDA Offers Revised Draft Guidance To Help

20 Oct 2021

• By Shawn M. Schmitt

Revised draft guidance document explains difference between hearing aids, regulated as medical devices, and personal sound amplification products, which aren’t. Guidance published with draft to allow hearing aids to be sold OTC.

Miniature businessmen chooses between two wooden block paths to success. — • Source: Alamy

The US Food and Drug Administration has revised a draft guidance to explain the difference between hearing aids, which are regulated as medical devices, and personal sound amplification products (PSAPs), which aren’t.

“FDA is aware of confusion in the marketplace over what FDA considers a hearing aid and what it considers a...