{"data":{"id":"us/21-cfr-874.1100","jurisdiction":"us","citation":"21 CFR 874.1100","heading":"Earphone cushion for audiometric testing.","body":"(a) Identification. An earphone cushion for audiometric testing is a device that is used to cover an audiometer earphone during audiometric testing to provide an acoustic coupling (sound connection path) between the audiometer earphone and the patient's ear.\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":"f61aa9913a82267fa68573033ad5e1da4eb6c80becb9f6be8d6831d2ab42b2e5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.1090","next":"us/21-cfr-874.1120"},"notice":"GroundRules: Original legal text. Not legal advice."}