Product code
ESD: Hearing aid, air-conduction, prescription
FDA product code · Class I · Ear Nose & Throat
Key facts
| Product code | ESD |
|---|---|
| Device | Hearing aid, air-conduction, prescription |
| Device class | Class I |
| Regulation number | 874.3300 |
| Review panel | Ear Nose & Throat |
| Medical specialty | Ear Nose & Throat |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 1,000+ 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1,000+ UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database