Electronic Code of Federal Regulations
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e-CFR data is current as of July 9, 2020 |
Title 21 → Chapter I → Subchapter H → Part 874 → Subpart D → §874.3330 |
Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart D—Prosthetic Devices
§874.3330 Master hearing aid.
(a) Identification. A master hearing aid is an electronic device intended to simulate a hearing aid during audiometric testing. It has adjustable acoustic output levels, such as those for gain, output, and frequency response. The device is used to select and adjust a person's wearable hearing aid.
(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]