Title 21: Food and Drugs
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/ PART 874 - EAR, NOSE, AND THROAT DEVICES
/ Subpart D - Prosthetic Devices / § 874.3330 Master hearing aid.
§ 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.