21 CFR §874.3305

1. (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.
2. (b)Classification. Class II (special controls). The special controls for this device are:
   1. (1)Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device;
   2. (2)Performance testing must validate safety of exposure to non-ionizing radiation; and
   3. (3)Performance data must validate wireless technology functions.
3. (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.