Last updated on Sep 14, 2018
“Personal sound amplifying products or PSAPs, a new category of product that were recently developed. They are nonmedical devices, more like electronic devices, intended for normal hearing people to amplify sounds such as if they’re at a sporting event or listening to birds.
I liken them to binoculars for the ears. They’re not medical devices and the FDA specifically precludes those companies from marketing to seniors or other people with hearing loss.
Hearing loss is a medical condition and it should be treated in a medical context by seeing a physician and using a FDA registered class one medical device such as a MD Hearing Aid product.”