RETROX
Device Facts
| Record ID | DEN020003 |
|---|---|
| Device Name | RETROX |
| Applicant | Auric Hearing Systems, Inc. |
| Product Code | NIX · Ear, Nose, Throat |
| Decision Date | Aug 20, 2002 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 874.3950 |
| Device Class | Class 2 |
Regulatory Classification
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.
