(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.
(b) Classification: Class II (special controls). The special controls for this device are:
(1) Appropriate analysis/testing should validate electro magnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;
(2) Design, description, and performance data should validate wireless technology functions; and
(3) Labeling should specify appropriate instructions, warnings, and information relating to EMC and wireless technology and human exposure to non-ionizing radiation.
(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]
Title 21 published on 2012-04-01
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