{"data":{"id":"us/21-cfr-874.3305","jurisdiction":"us","citation":"21 CFR 874.3305","heading":"Wireless air-conduction hearing aid.","body":"(a) Identification. A wireless air-conduction hearing aid is a wearable sound-amplifying device, intended to compensate for impaired hearing that incorporates wireless technology in its programming or use. A wireless air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable.\n(b) Classification. Class II (special controls). The special controls for this device are:\n(1) Performance data must demonstrate the electromagnetic compatibility (EMC), electrical safety, and thermal safety of the device;\n(2) Performance testing must validate safety of exposure to non-ionizing radiation; and\n(3) Performance data must validate wireless technology functions.\n(c) Premarket notification. The wireless air-conduction hearing aid 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 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":"79e3d665eba9b6740d0d179b77b5ad2f54fdeb2f579a9cf9407c4be9fa78a2e7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.3302","next":"us/21-cfr-874.3310"},"notice":"GroundRules: Original legal text. Not legal advice."}