21 C.F.R. · Food and Drugs
21 C.F.R. § 874.3320

Group hearing aid or group auditory trainer.

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 874.3320 — Group hearing aid or group auditory trainer.

§ 874.3320 Group hearing aid or group auditory trainer. (a) Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9. [51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]

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21 C.F.R. § 874.3320
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The regulatory text of 21 C.F.R. § 874.3320 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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