← Product Code [NIX](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NIX) · DEN020003

# RETROX (DEN020003)

_Auric Hearing Systems, Inc. · NIX · Aug 20, 2002 · Ear, Nose, Throat · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NIX/DEN020003

## Device Facts

- **Applicant:** Auric Hearing Systems, Inc.
- **Product Code:** [NIX](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NIX.md)
- **Decision Date:** Aug 20, 2002
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 874.3950
- **Device Class:** Class 2
- **Review Panel:** Ear, Nose, Throat

## Regulatory Identification

A transcutaneous air conduction hearing aid system is a wearable sound-amplifying device intended to compensate for impaired hearing without occluding the ear canal. The device consists of an air conduction hearing aid attached to a surgically fitted tube system, which is placed through soft tissue between the post auricular region and the outer ear canal. A transcutaneous air conduction hearing aid system is subject to the requirements in § 801.422 of this chapter.

## Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Transcutaneous Air Conduction Hearing Aid System (TACHAS); Guidance for Industry and FDA.” See § 874.1 for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NIX/DEN020003](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NIX/DEN020003)

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