# Hearing Aid, Air-Conduction With Wireless Technology, Prescription
> **Product code: OSM** · Class II — Moderate Risk (510(k) clearance required) · Ear, Nose, Throat · 21 CFR 874.3305
## Classification
- **FDA Product Code:** OSM
- **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 a prescprition hearing aid.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 76
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OSM)
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