title: Medical Devices; Ear, Nose, and Throat Devices; Classification of   the Tympanic Membrane Contact Hearing Aid. Final order.
abstract: The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid's classification. 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 / Q000145:classification*; D006801:Humans; D010036:Otolaryngology / Q000145:classification* / Q000295:instrumentation*; D014432:Tympanic Membrane; D014481:United States; D014486:United States Food and Drug Administration