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Code · CFR · Title 21 — Food and Drugs · Part 874 — Ear, Nose, and Throat Devices · § 874.3310

§ 874.3310. Hearing aid calibrator and analysis system.

121 words·~1 min read·/us/cfr/t21/s§ 874.3310·

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(a)Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.
(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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