File 003 · AgeTech
Record 125 · Health · 2021
21.125.HBose SoundControl
Bose / Lexie Hearing
“The first FDA-cleared self-fitting hearing aid, sold like consumer audio.”
A hearing aid from a headphone company.
Bose SoundControl (later in the Lexie/Bose line) proved you could self-fit a hearing aid with an app. It prefigured the 2022 OTC rule.
Opened self-fit hearing as a regulated consumer product.
Filed notes
- FDA self-fitting hearing aid
- App-based fit
- Audio-brand distribution
SIC
3842
Orthopedic, Prosthetic, and Surgical Appliances and Supplies
NAICS
334510
Electromedical and Electrotherapeutic Apparatus Manufacturing
