§ 874.3305. Wireless air-conduction hearing aid.
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/us/cfr/t21/s§ 874.3305·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]
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§ 874.3305
Wireless air-conduction hearing aid.
Fed. Reg.×2
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