21 CFR 874.3305 - Wireless air-conduction hearing aid.

§ 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.

(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]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 10-May-2017 03:43

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 874 after this date.

  • 2016-10-24; vol. 81 # 205 - Monday, October 24, 2016
    1. 81 FR 73028 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective October 24, 2016. The classification was applicable on September 16, 2016.
      21 CFR Part 874