Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus

Official abstract: The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the combined acoustic and electrical external stimulation device for the relief of tinnitus. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.