NIX · Hearing Aid, Air Conduction, Transcutaneous System
Ear, Nose, Throat · 21 CFR 874.3950 · Class 2
Overview
| Product Code | NIX |
|---|---|
| Device Name | Hearing Aid, Air Conduction, Transcutaneous System |
| Regulation | 21 CFR 874.3950 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 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 | RETROX TITANIUM TUBE SYSTEM FOR THE RETROX TRANSCUTANEOUS AIR CONDUCTION HEARING AID SYSTEM | Gyrus Ent LLC | Aug 20, 2004 | SESE |
| DEN020003 | RETROX | Auric Hearing Systems, Inc. | Aug 20, 2002 | DENG |
Top Applicants
- Gyrus Ent LLC — 1 clearance
- Auric Hearing Systems, Inc. — 1 clearance
