← Product Code [MAH](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH) · K150555

# BA400 14mm Abutment (K150555)

_Cochlear Americas · MAH · Jul 15, 2015 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K150555

## Device Facts

- **Applicant:** Cochlear Americas
- **Product Code:** [MAH](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH.md)
- **Decision Date:** Jul 15, 2015
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 874.3302
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K150555](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/MAH/K150555)

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