(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 (Sec. 874.3320), master hearing aid (Sec. 874.3330), and tinnitus masker (Sec. 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 Sec. 874.9.
(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 Sec. 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]