# Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
> **Product code: QUG** · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3305
## Classification
- **FDA Product Code:** QUG
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 874.3305
- **Review panel:** EN
- **Medical specialty:** Ear, Nose, Throat
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use.  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:** 82
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QUG)
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