QUG

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Product code

QUG

Device name

Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter

Device class

Class 2

21 CFR

21 CFR 874.3305

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K) Exempt

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 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.

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