---
kind: "section"
citation: "21 C.F.R. § 874.3950"
title: "21"
number: "874.3950"
heading: "Transcutaneous air conduction hearing aid system."
url: "https://uscodex.org/cfr/21/874.3950"
---

# §874.3950. Transcutaneous air conduction hearing aid system.

- (a) **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](/cfr/21/801.422.md) of this chapter.
- (b) **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](/cfr/21/874.1.md) for the availability of this guidance document.

## Notes

### Amendments

[67 FR 67790, Nov. 7, 2002, as amended at 87 FR 50762, Aug. 17, 2022]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.

### Amendments

[67 FR 67790, Nov. 7, 2002, as amended at 87 FR 50762, Aug. 17, 2022]