Noninvasive therapeutic hypothermia for tinnitus

Restorear Devices, Llc, Bozeman MT

Investigators

Linked publications, trials & patents

Abstract

Project Summary Tinnitus is a common medical symptom that is debilitating and life-changing for a significant population with the primary risk factors that involve peripheral hearing loss, ototoxic medication, otological diseases, and head injury. It is estimated to affect between 10 to 20% of adults worldwide. While many patients cope with tinnitus, nearly 1 in 10 (or more) experience severe symptoms leading to significant decrease in quality of life and socioeconomic burden to the society. Despite significant health burden presented by tinnitus there exists no cure and there are no short term/acute therapies for reducing tinnitus loudness. The proposed project aims to test whether the non- invasive, non-pharmaceutical delivery of mild therapeutic hypothermia (MTH) targeting multiple cellular and molecular pathways in the inner ear provides symptomatic relief of tinnitus and reduces tinnitus severity. RestorEar’s long-term goals are to develop localized therapeutic hypothermia as a non-invasive intervention for symptomatic relief of tinnitus and to manage tinnitus severity, providing acute relief to patients with chronic tinnitus. We have already shown that using our novel device ReBoundTM, MTH can be applied quickly following onset of trauma to modulate protective mechanisms in the cochlea. Here, this approach will be extended to a group of patients suffering from tinnitus. We will measure the effects of this experimental intervention using standard and validated psychometric and audiometric functional assessments. With strong results collected during this Phase I project, we aim to show that MTH delivered to the inner ear will mitigate tinnitus severity and lead to a new approach for acute and chronic tinnitus management. This approach carries high potential for rapid translation to the clinic. We will test and optimize this treatment in a randomized clinical study. These results are expected to lead to a larger multi-site study in Phase 2. Combined with the commercialization of FDA cleared, patient-ready devices (“ReBoundRx”), the clinical studies proposed will establish a novel therapy for symptomatic relief and management of tinnitus.