§874.3302. Bone-conduction hearing aid.
21 C.F.R. § 874.3302
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.
Classification. Class II.
Notes, amendments, and revision history
Amendments
[87 FR 50762, Aug. 17, 2022]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
Amendments
[87 FR 50762, Aug. 17, 2022]