This week, a new RestorEar-sponsored clinical trial titled “Noninvasive Therapeutic Hypothermia for Tinnitus” received Institutional Review Board approval to begin recruitment. RestorEar and our collaborators at the University of Miami were awarded a Small Business Innovation Research (SBIR) Grant from the National Institute on Deafness and Other Communication Disorders (NIDCD) earlier this spring to complete this year-long project studying tinnitus symptom management with therapeutic hypothermia. This wonderful news comes as we begin the second year of another study, “Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss”, which explores the use of ReBound-delivered cooling for the prevention of noise-induced hearing loss in firefighters. 

Using preliminary research from RestorEar co-founder Dr. Suhrud Rajuguru’s lab as well as pilot studies at the University of Miami Division of Audiology, this new Phase 1 study will expand on past findings with in-human applications of external cooling for patients with chronic tinnitus (ringing in the ears). Tinnitus impacts 15% to 20% of people, particularly those with frequent loud noise exposure, and is linked to increased risk of anxiety, depression, sleep problems, and worse quality of life. Though there are some treatments aimed at reducing severity, there is no cure for tinnitus, and many options are impractical or ineffective for individuals.

The RestorEar team is excited to see the launch of this new clinical trial that offers the potential to fill the gaps in tinnitus care. For updates on the research, visit our Clinical Page, check out clinicaltrials.gov, and subscribe to our newsletter.