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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 874 - EAR, Nose, and Throat Devices |
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Subpart D - Prosthetic Devices |
§ 874.3330 - Master hearing aid.
Latest version.
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§ 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]