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The Sanuthera's Serenity device is indicated to provide a mean of sound enrichment therapy that is programmed by a hearing health care professional familiar with diagnosis and management of tinnitus as part of a personalized tinnitus management program to provide temporary relief from the tinnitus symptoms. The target population is primarily the adult population over 18 years of age.

Sanuthera's Serenity is a device utilizing sound therapy as a means to mitigate the symptoms associated with tinnitus. The Serenity device works as a plug-in device to the uDirect2 bridge device, manufactured by a hearing- aid company Unitron and can be customized to a patient's tinnitus profile and then adjusted to his/her preference to play a number of sounds aimed at obscuring the ringing in the patient's ear and/or re-train patients to avoid focusing on the ringing, essentially “habituating” them away from the disease. The process of providing tinnitus therapy occur a number of ways although the most popular are Tinnitus Retraining Therapy (TRT) and Tinnitus Masking (TM). In either case, the patient is provided with the Serenity device which is custom programmed. The patient is then taken through a process of multiple protocols to set filter and volume parameters via an onboard processing unit and an onboard digital band pass filter to slowly assist in the habituation to the tinnitus. Associated Accessories: • The Software that is utilized by an audiologist to customize, per patient's preference during the device fitting process, the sounds aimed at obscuring the ringing in the patient's ear and/or re-train patients to avoid focusing on the ringing. • The Unitron's commercially available neck-worn uDirect2 bridge device with Unitron's Moxi Kiss Behind-the-Ear family hearing aids (K130494). • The battery charger to simultaneously charge in parallel the batteries of the Serenity and the uDirect2 bridge device.