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e-CFR data is current as of February 26, 2021

Title 21Chapter ISubchapter HPart 874Subpart B → §874.1070


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart B—Diagnostic Devices


§874.1070   Short increment sensitivity index (SISI) adapter.

(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]

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