§874.3305. Wireless air-conduction hearing aid.
21 C.F.R. § 874.3305
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.
Classification. Class II (special controls). The special controls for this device are:
Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device;
Performance testing must validate safety of exposure to non-ionizing radiation; and
Performance data must validate wireless technology functions.
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.
Notes, amendments, and revision history
Amendments
[76 FR 34846, June 15, 2011, as amended at 87 FR 50762, Aug. 17, 2022]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
Amendments
[76 FR 34846, June 15, 2011, as amended at 87 FR 50762, Aug. 17, 2022]