title: Medical devices; ear, nose, and throat devices; classification of the wireless air-conduction hearing aid. Final rule.
abstract: The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence*; D004869:Equipment Safety / Q000145:classification*; D006310:Hearing Aids / Q000009:adverse effects / Q000145:classification*; D006801:Humans; D011840:Radiation, Nonionizing / Q000009:adverse effects; D014481:United States; D059015:Wireless Technology / Q000145:classification* / Q000295:instrumentation / Q000331:legislation & jurisprudence