Wireless air-conduction hearing aid.

21 C.F.R. § 874.3305
in effectEffective: 2024-07-01
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(a) Identification. A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. A wireless air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. (b) Classification. Class II (special controls). The special controls for this device are: (1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device; (2) Performance testing must validate safety of exposure to non-ionizing radiation; and (3) Performance data must validate wireless technology functions. (c) Premarket notification. The wireless air-conduction hearing aid is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.

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