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§874.3302. Bone-conduction hearing aid.

21 C.F.R. § 874.3302

(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.
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]