21 C.F.R. § 874.3330

Master hearing aid.

Last amended: 2019Year: 2026Length: 93 wordsSubsections: 2Official source

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.
21 C.F.R. § 874.3330: Master hearing aid. | Justis AI