{"data":{"id":"us/21-cfr-874.3310","jurisdiction":"us","citation":"21 CFR 874.3310","heading":"Hearing aid calibrator and analysis system.","body":"(a) Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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 D—Prosthetic 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":"a2bfae2a76b80a19bca937892cd964d296c49e144b071df5583f315ae0bf64d0","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.3305","next":"us/21-cfr-874.3315"},"notice":"GroundRules: Original legal text. Not legal advice."}