# Hearing Aid, Air-Conduction, Over The Counter
> **Product code: QUF** · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.3300
## Classification
- **FDA Product Code:** QUF
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 874.3300
- **Review panel:** EN
- **Medical specialty:** Ear, Nose, Throat
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 77
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QUF)
---
*AI Analytics · CC0 1.0*