21 CFR 874.3302
§ 874.3302 Bone-conduction hearing aid.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.3302, § 874.3302 Bone-conduction hearing aid, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90208
- Permanent ID
ys:prov:90208@1- SHA-256
a3901909cf10fac6d6e5a3706b3c92bcb3834a6b28c292b7dd28241a6614a73c
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Full text
(a) Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.
(b) Classification. Class II.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.