21 C.F.R. § 874.3330

Current through October 31, 2024
Section 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 .

21 C.F.R. §874.3330

51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813 , Dec. 30, 2019