§ 874.3410 Combined acoustic and electrical external stimulation device for the relief of tinnitus.

(a) Identification. A combined acoustic and electrical external stimulation device for the relief of tinnitus is a device that provides acoustic stimulation in the ear and external, electrical stimulation of sensory nerves to relieve tinnitus. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must demonstrate performance as intended under anticipated conditions for use including the following: (i) Evaluation of tinnitus symptoms using a validated method; and (ii) Evaluation of all adverse events. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Verification of specified electrical stimulation parameters; and (ii) Verification of specified acoustic stimulation parameters, including maximum output limits, distortion levels, and frequency response. (3) Performance data must demonstrate the electromagnetic compatibility, battery safety, and electrical safety of the device. (4) Software verification, validation, and hazard analysis must be performed. (5) The patient-contacting components of the device must be demonstrated to be biocompatible. (6) Human factors testing must demonstrate that users can successfully use the device in the intended use environment based solely on its labeling and instructions for use. (7) Labeling must include the following: (i) A statement that the device is intended to be prescribed by a healthcare professional with expertise in the evaluation and management of tinnitus; (ii) Information regarding emotional, psychological, and physical considerations for patient selection; and (iii) Device specifications, including the materials of patient-contacting components of the device, electrical output waveform, stimulation peak voltage and current, pulse duration, frequency, maximum current density, maximum phase charge, and power source.