21 CFR 874.3950
§ 874.3950 Transcutaneous air conduction hearing aid system.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3950, § 874.3950 Transcutaneous air conduction hearing aid system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90232
- Permanent ID
ys:prov:90232@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.