# Hearing Aid, Air-Conduction, Prescription
> **Product code: ESD** · Class I — Low Risk (general controls) · Ear, Nose, Throat · 21 CFR 874.3300
## Classification
- **FDA Product Code:** ESD
- **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 a prescription hearing aid.

## Market data
- **Cleared 510(k) submissions:** 1367
- **Registered establishments:** 99
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=ESD)
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