A Novel Technology to Treat the Underlying Cause of Tinnitus

Project Summary / Abstract Tinnitus is the pervasive and often debilitating perception of ringing, buzzing, or hissing sounds in the absence of external stimuli. Sufferers face significant challenges that diminish quality of life, including sleep disturbances, cognitive difficulties, and reduced productivity. Additionally, the prevalence of mental health conditions, including anxiety, depression, and somatic symptom disorders, is significantly higher in patients suffering from tinnitus. Veterans suffering from tinnitus also have a higher likelihood of screening positive for PTSD. In the United States, up to 50 million people have tinnitus, among whom 20 million are chronic sufferers actively seeking relief. About 3 million veterans receive tinnitus disability compensation annually making it the number one service-connected disability for the Department of Veterans Affairs. Despite the overwhelming need for an effective treatment, today’s options are unsatisfactory to most patients; 20% report receiving no help when visiting their general practitioner for tinnitus, over 66% receive no tinnitus care or management after being discharged by ear, nose, and throat (ENT) specialists, and 40% of those discharged return to their general practitioner seeking further help. The major limitation of today’s treatment options is their failure to address the underlying pathology of tinnitus – dysregulated neural synchrony. Common treatments such as hearing aids and sound masking devices do not take this into consideration, instead treating tinnitus as if it were simply an ear disorder. As a result, these treatments can exacerbate symptoms in some patients. Auricle’s novel medical device is the first in-home neuromodulatory device that treats the root cause of tinnitus. Our internationally-patented technology is based on a strong body of peer-reviewed literature. The system applies auditory stimuli at tinnitus frequencies with precisely timed somatosensory stimuli in the neck or face to suppress the tinnitus-generating neurons that cause auditory symptoms. Our technology is supported by 33 peer-reviewed publications and has repeatedly been demonstrated to be safe and effective in clinical trials. Through this SBIR project, the validated technology will be refined for ease-of-ease and scalability, preparing it for commercialization in order to bring transformative relief to tinnitus sufferers.