21 CFR 874.1070
§ 874.1070 Short increment sensitivity index (SISI) adapter.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.1070, § 874.1070 Short increment sensitivity index (SISI) adapter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90194
- Permanent ID
ys:prov:90194@1- SHA-256
aadbbcb4ca3eb32232335f309c9486bc73926765abc5b40328de77b2708317b7
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.