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The HyperSound Timitus Module is indicated for patient home use in the temporary relief of tinnitus symptoms. The device is available in HyperSound Clear 500P audio systems to generate and deliver personalized sound output to timitus patients with or without hearing loss and with or without hearing aids. Any fitting of the device must be done by a hearing care professional. The target population is primarily adults (18 years or older).

The HyperSound Tinnitus Module is a tool to a cleared device that provides the means to create personalized sound output to provide temporary relief to patients suffering from tinnitus. It is available as a firmware option embedded in the commercially available over the counter HyperSound Clear 500P system ("500P"), a Class II, 510(k)- cleared group hearing aid (K133352). The 500P consists of an amplifier and one or two emitters (directed audio speakers) and accompanying mains power supply. Like the 500P, the HyperSound Tinnitus Module may be used by individuals with or without hearing loss and with or without hearing aids. As part of the prescription activation of the HyperSound Tinnitus Module option, a hearing care professional ("HCP") programs a Tinnitus EQ setting for the patient which may be a standard flat EQ or a custom EQ to fit to a patient's hearing loss and/or to shape frequency output to the user's tinnitus therapy preferences. The activation and programming by the HCP is accomplished using the HyperFit fitting software tool only available to HCPs for use with the 500P. The user may select amongst relief sounds, fine-tune up to nine EQ bans to their liking and adjust common audio settings on the 500P device such as volume and balance (left and right speaker).