Section 874.3305 - Wireless air-conduction hearing aid(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 . 76 FR 34846 , June 15, 2011, as amended at 87 FR 50762 , Aug. 17, 2022