{"data":{"id":"us/21-cfr-874.1070","jurisdiction":"us","citation":"21 CFR 874.1070","heading":"Short increment sensitivity index (SISI) adapter.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 874—EAR, NOSE, AND THROAT DEVICES","Subpart B—Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"4826366ef0c49ac52e43e78f9755124c86d193a3ff1386cb01f960ca79cac424","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.1060","next":"us/21-cfr-874.1080"},"notice":"GroundRules: Original legal text. Not legal advice."}