# OAF · Implant, Hearing, Active, Middle Ear, Totally Implanted

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/OAF

## Overview

- **Product Code:** OAF
- **Device Name:** Implant, Hearing, Active, Middle Ear, Totally Implanted
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Identification

Intended to provide useful hearing to persons with sensorineural hearing loss. Indicated for adults with mild to severe sensorineural hearing loss who have a speech discrimination score greater than or equal to 60%.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P090018](/device/P090018.md) | ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM | Envoy Medical Corporation | Mar 17, 2010 | APPR |

## Top Applicants

- Envoy Medical Corporation — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/OAF](https://fda.innolitics.com/productcode/OAF)

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