874.3300 Hearing Aid.§ 874.3300 Hearing Aid.
(a) Identification. A hearing aid is wearable sound-amplifying device that is intended to compensate for impaired hearing. This generic type of device includes the air-conduction hearing aid and the bone-conduction hearing aid, but excludes the group hearing aid or group auditory trainer (§ 874.3320), master hearing aid (§ 874.3330), and tinnitus masker (§ 874.3400).
(b) Classification. (1) Class I (general controls) for the air-conduction hearing aid. The air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.
(2) Class II for the bone-conduction hearing aid.[51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000]