21 C.F.R. · Food and Drugs
21 C.F.R. § 874.3302

Bone-conduction hearing aid.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 874.3302 — Bone-conduction hearing aid.

§ 874.3302 Bone-conduction hearing aid. (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. [87 FR 50762, Aug. 17, 2022]

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21 C.F.R. § 874.3302
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The regulatory text of 21 C.F.R. § 874.3302 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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