21 CFR 874.3950 — Hearing Aid, Air Conduction, Transcutaneous System
Ear, Nose, Throat (EN) · Part 874 Subpart D—Prosthetic Devices · § 874.3950
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| NIX | Hearing Aid, Air Conduction, Transcutaneous System | 2 | 2 | Implant |
Special Controls
NIX — Hearing Aid, Air Conduction, Transcutaneous System
*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.
eCFR
NIX — Hearing Aid, Air Conduction, Transcutaneous System
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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