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QUHClass II

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

21 CFR 874.3325 / Ear, Nose, Throat
FDA source (opens on fda.gov)

QUH is the FDA product code for Self-Fitting Air-Conduction Hearing Aid, Over The Counter, a class II device type, regulated under 21 CFR 874.3325. FDA's definition for this code reads: "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...". As of , FDA records hold 10 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QUH
Device name
Self-Fitting Air-Conduction Hearing Aid, Over The Counter
FDA 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.
Regulation
21 CFR 874.3325
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
10
Ingested recalls
0

Clearances, product code QUH

By decision year
10 clearances under product code QUH with a decision year between 2022 and 2026, 2023 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code QUH by decision year
YearClearances
20222
20235
20242
20261

Applicants with the most clearances

Product code QUH
Applicants holding the most 510(k) clearances under product code QUH
ApplicantClearances
Concha Labs1
Eargo Inc1
GN Hearing A/S1
Hearx SA (Pty), Ltd.1
Huizhou Jinghao Medical Technology Co., Ltd1
Nuheara Inc.1
Sonova AG1
Soundwave Hearing, LLC1
Tuned, Ltd.1
Wsaud A/S1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order