Not Sure If You’re Making Hearing Aids Or PSAPs? FDA’s New Draft Guidance Should Help

20 Oct 2021

• By Shawn M. Schmitt

A guidance document proposed by the US agency on 20 October explains the difference between hearing aids, which are regulated as medical devices, and personal sound amplification products – or PSAPs – which aren’t.

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

The US Food and Drug Administration on 20 October issued a revised draft guidance document that explains the difference between hearing aids, which are regulated as medical devices, and personal sound amplification products (PSAPs), which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...