21 CFR § 874.3950 - Transcutaneous air conduction hearing aid system.

---
identifier: "/us/cfr/t21/s874.3950"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.3950 - Transcutaneous air conduction hearing aid system."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.3950"
section_name: "Transcutaneous air conduction hearing aid system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 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 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 for the availability of this guidance document.

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