← Product Code [LXB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB) · K881382

# XOMED AUDIANT BONE CONDUCTOR (K881382)

_Xomed, Inc. · LXB · Jun 21, 1988 · Ear, Nose, Throat · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K881382

## Device Facts

- **Applicant:** Xomed, Inc.
- **Product Code:** [LXB](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB.md)
- **Decision Date:** Jun 21, 1988
- **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/LXB/K881382](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/LXB/K881382)

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