§874.3330. Master hearing aid.
21 C.F.R. § 874.3330
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.
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.
Notes, amendments, and revision history
Amendments
[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 51 FR 40389, Nov. 6, 1986, unless otherwise noted.
Amendments
[51 FR 40389, Nov. 6, 1986, as amended at 84 FR 71813, Dec. 30, 2019]