21 CFR 874.3400
§ 874.3400 Tinnitus masker.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3400, § 874.3400 Tinnitus masker, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90217
- Permanent ID
ys:prov:90217@1- SHA-256
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Full text
(a) Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.
(b) Classification. Class II. The special control for this device is patient labeling regarding:
(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.