Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
QUG · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3305
Classification
FDA Product Code
QUG
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 an over the counter hearing aid. For information on the final rule Establishing Over-the-Counter Hearing Aids, please see 87 FR 50698, available at https://www.govinfo.gov/content/pkg/FR-2022-08-17/pdf/2022-17230.pdf.