Browse hierarchy: [Ear, Nose, Throat (EN)](/submissions/EN) → [Subpart D — Prosthetic Devices](/submissions/EN/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 874.3950](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3950) → NIX — Hearing Aid, Air Conduction, Transcutaneous System

# NIX · Hearing Aid, Air Conduction, Transcutaneous System

_Ear, Nose, Throat · 21 CFR 874.3950 · Class 2_

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

## Overview

- **Product Code:** NIX
- **Device Name:** Hearing Aid, Air Conduction, Transcutaneous System
- **Regulation:** [21 CFR 874.3950](/submissions/EN/subpart-d%E2%80%94prosthetic-devices/874.3950)
- **Device Class:** 2
- **Review Panel:** [Ear, Nose, Throat](/submissions/EN)
- **Implant:** yes

## 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.

## Classification Rationale

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.

## 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.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K040996](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NIX/K040996.md) | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | Gyrus Ent LLC | Aug 20, 2004 | SESE |
| [DEN020003](https://fda.innolitics.com/submissions/EN/subpart-d%E2%80%94prosthetic-devices/NIX/DEN020003.md) | RETROX | Auric Hearing Systems, Inc. | Aug 20, 2002 | DENG |

## Top Applicants

- Gyrus Ent LLC — 1 clearance
- Auric Hearing Systems, Inc. — 1 clearance

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

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