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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.
Code of Federal Regulations
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