FDA product code QUF: Hearing Aid, Air-Conduction, Over The Counter
QUF is the FDA product code for hearing aid, air-conduction, over the counter. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel. Devices under QUF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. 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 | Hearing Aid, Air-Conduction, Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 874.3300 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Recalls for QUF devices
openFDA lists no recalls for product code QUF.
Frequently asked questions
What is FDA product code QUF?
QUF is the FDA product code for hearing aid, air-conduction, over the counter. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel.
What device class is QUF?
Class I, regulation 21 CFR 874.3300. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code QUF
- Run a recall and safety report across every QUF manufacturer
- Watch product code QUF 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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