FDA product code QUH: Self-Fitting Air-Conduction Hearing Aid, Over The Counter
QUH is the FDA product code for self-fitting air-conduction hearing aid, over the counter. It is a Class II device, regulated under 21 CFR 874.3325 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 10 510(k) submissions under QUH, 10 in the last five years, from 10 different applicants. The average 510(k) review took 202 days (median 174); 150 days on average over the last three years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Self-Fitting Air-Conduction Hearing Aid, Over The Counter |
| Device class | Class II |
| Regulation | 21 CFR 874.3325 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) |
510(k) clearances per year for QUH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 2 | 196 |
| 2023 | 5 | 242 |
| 2024 | 2 | 112 |
| 2026 | 1 | 188 |
Compare with all 510(k) review times · Search every QUH clearance
Top QUH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| GN Hearing A/S | 1 | 2026-06-25 |
| Concha Labs | 1 | 2024-03-15 |
| Wsaud A/S | 1 | 2024-02-09 |
| Soundwave Hearing, LLC | 1 | 2023-10-26 |
| Huizhou Jinghao Medical Technology Co., Ltd. | 1 | 2023-09-25 |
5 more applicants have QUH clearances. See the full list in Caduvo.
Most recent QUH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254108 | GN Hearing A/S | Jabra Enhance Select Self-fit (Jabra Enhance Select 550) | 2026-06-25 | 188 |
| K233747 | Concha Labs | Concha Sol Hearing Aids (CL-1001) | 2024-03-15 | 114 |
| K233464 | Wsaud A/S | WSA Self-Fitting Hearing Aid Gen 2 | 2024-02-09 | 109 |
| K231550 | Soundwave Hearing, LLC | Sontro® OTC Hearing Aids (AI) | 2023-10-26 | 149 |
| K221052 | Huizhou Jinghao Medical Technology Co., Ltd. | Self-Fitting hearing aids | 2023-09-25 | 532 |
Recalls for QUH devices
openFDA lists no recalls for product code QUH.
Frequently asked questions
What is FDA product code QUH?
QUH is the FDA product code for self-fitting air-conduction hearing aid, over the counter. It is a Class II device, regulated under 21 CFR 874.3325 and reviewed by the Ear, Nose and Throat panel.
What device class is QUH?
Class II, regulation 21 CFR 874.3325. Typical premarket route: 510(k).
How long does a 510(k) take for product code QUH?
Across 10 cleared submissions the average was 202 days from receipt to decision (median 174).
Which companies have the most QUH clearances?
GN Hearing A/S (1); Concha Labs (1); Wsaud A/S (1); Soundwave Hearing, LLC (1); Huizhou Jinghao Medical Technology Co., Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QUH
- Run a recall and safety report across every QUH manufacturer
- Watch product code QUH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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