21 C.F.R. § 874.1120

Current through September 30, 2024
Section 874.1120 - Electronic noise generator for audiometric testing
(a)Identification. An electronic noise generator for audiometric testing is a device that consists of a swept frequency generator, an amplifier, and an earphone. It is intended to introduce a masking noise into the non-test ear during an audiometric evaluation. The device minimizes the non-test ear's sensing of test tones and signals being generated for the ear being tested.
(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. §874.1120

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