{"data":{"id":"us/21-cfr-874.3302","jurisdiction":"us","citation":"21 CFR 874.3302","heading":"Bone-conduction hearing aid.","body":"(a) Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.\n(b) Classification. Class II.","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":"5899614e906e9407fab8d87fa9bef09c2a8c86a0f4a701d2b4019324ca6e24be","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.3300","next":"us/21-cfr-874.3305"},"notice":"GroundRules: Original legal text. Not legal advice."}