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e-CFR data is current as of February 26, 2021

Title 21Chapter ISubchapter HPart 874Subpart D → §874.3310


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart D—Prosthetic Devices


§874.3310   Hearing aid calibrator and analysis system.

(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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