Hearing Aid, Air-Conduction With Wireless Technology, Prescription
OSM · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3305
Classification
FDA Product Code
OSM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 874.3305
Review panel
EN
Medical specialty
Ear, Nose, Throat
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.