QUH

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Product code

QUH

Device name

Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Device class

Class 2

21 CFR

21 CFR 874.3325

Medical specialty

Ear, Nose, Throat

Marketing pathway

510(K)

510(k) clearances (last 3 years)

5

Summaries archived here

5 (direct download)

510(k) clearances (all years, FDA)

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

FDA classification definition

A self-fitting air-conduction hearing aid is a wearable sound amplifying device that is intended to compensate for impaired hearing and incorporates technology, including software, that allows users to program their hearing aids. This technology integrates user input with a self-fitting strategy and enables users to independently derive and customize their hearing aid fitting and settings. 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).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-06-25.

5 summaries are archived here for direct download.