Bone-conduction hearing aid.

21 C.F.R. § 874.3302
in effectEffective: 2024-07-01
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(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.

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