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Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief to patients suffering from tinnitus as part of a tinnitus management program. The target population is the adult population (>18yrs). Tinnitus SoundSupport is targeted for licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing losses. The fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.

Oticon's Tinnitus SoundSupport consists of a software module added to the company's class II, 510(k)-exempt wireless air conduction hearing instruments legally marketed under 21 C.F.R. 874.3305. Tinnitus SoundSupport is fitted to the patient by the Hearing Care Professional using Oticon fitting software. Tinnitus SoundSupport provides the option of relief sounds based on white, pink or red noise. The relief sounds can be limited in frequency by high pass or low pass filters. Tinnitus SoundSupport also provides the option of amplitude modulation, a volume control and automatic level steering. The design of Tinnitus SoundSupport is based on the controls of the Occupational Safety and Health Administration (OSHA). Compliance with OSHA controls is achieved through (1) output limitation and (2) professional labeling and (3) patient labeling. Tinnitus SoundSupport must be used as part of a tinnitus management program.