OSM

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Product code

OSM

Device name

Hearing Aid, Air-Conduction With Wireless Technology, Prescription

Device class

Class 2

21 CFR

21 CFR 874.3305

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. This is a prescprition hearing aid.

Definition text from the FDA device classification database (U.S. federal government work, public domain).