Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3302](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3302) → MAH — Hearing Aid, Bone Conduction, Implanted

# MAH · Hearing Aid, Bone Conduction, Implanted

_Ear, Nose, Throat · 21 CFR 874.3302 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH

## Overview

- **Product Code:** MAH
- **Device Name:** Hearing Aid, Bone Conduction, Implanted
- **Regulation:** [21 CFR 874.3302](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3302)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **Implant:** yes

## Identification

A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.

## Classification Rationale

Class II.

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K203807](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K203807.md) | Ponto Bone Anchored Hearing System, MONO Surgery Kit | Oticon Medical AB | Mar 3, 2021 | SESE |
| [K182116](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K182116.md) | BA310 Abutment, BIA310 Implant/Abutment | Cochlear Americas | Dec 19, 2018 | SESE |
| [K152820](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K152820.md) | Ponto Bone Anchored Hearing System | Oticon Medical AB | Jan 22, 2016 | SESE |
| [K152067](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K152067.md) | Ponto bone anchored hearing system | Oticon Medical AB | Nov 23, 2015 | SESE |
| [K150555](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K150555.md) | BA400 14mm Abutment | Cochlear Americas | Jul 15, 2015 | SESE |
| [K142678](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K142678.md) | Ponto Bone Anchored Hearing system/ Abutment, 14mm. Ponto Bone Anchored Hearing System / Wide implant, 4mm, with abutment, 14 mm | Oticon Medical AB | Jan 21, 2015 | SESE |
| [K121317](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K121317.md) | COCHLEAR BAHA IMPLANT SYSTEM | Cochlear Americas | Oct 12, 2012 | SESE |
| [K121228](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K121228.md) | PONTO BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | Sep 7, 2012 | SESE |
| [K112053](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K112053.md) | OBC BONE ANCHORED HEARING SYSTEM | Oticon Medical AB | Nov 18, 2011 | SESE |
| [K080363](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K080363.md) | BAHA CORDELLE II | Cochlear Bone Anchored Systems AB | Apr 10, 2008 | SESE |
| [K984162](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K984162.md) | BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE | Nobelpharma USA, Inc. | Jun 28, 1999 | SESE |

## Top Applicants

- Oticon Medical AB — 6 clearances
- Cochlear Americas — 3 clearances
- Nobelpharma USA, Inc. — 1 clearance
- Cochlear Bone Anchored Systems AB — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH)

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