21 C.F.R. § 874.3330
Master hearing aid.
Cite as 21 C.F.R. § 874.3330 (2026)
(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]
- Cross-references to the CFR
- 874.9.