21 C.F.R. § 874.1070

Short increment sensitivity index (SISI) adapter.

Last amended: 2016Year: 2026Length: 88 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 874.1070 (2026)

(a) Identification. A short increment sensitivity index (SISI) adapter is a device used with an audiometer in diagnostic hearing evaluations. A SISI adapter provides short periodic sound pulses in specific small decibel increments that are intended to be superimposed on the audiometer's output tone frequency. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 FR 2315, Jan. 14, 2000]
Cross-references to the CFR
874.9.
21 C.F.R. § 874.1070: Short increment sensitivity index (SISI) adapter. | Justis AI