21 C.F.R. § 874.3302

Current through September 30, 2024
Section 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.

21 C.F.R. §874.3302

87 FR 50762, Aug. 17, 2022
87 FR 50762, 10/17/2022