We are excited to announce that RestorEar Devices has been awarded a Small Business Innovation Research Grant (SBIR) from the National Institutes of Health (NIH)/National Institute on Deafness and Other Communication Disorders (NIDCD) for our latest study titled “Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss”.

In collaboration with clinical colleagues at the University of Miami School of Medicine and the Department of Otolaryngology, this Phase II human clinical trial will investigate the efficacy of a clinical version of ReBound, a first of its kind hearing health device, for post noise exposure hearing loss prevention in a group of noise exposed firefighters. This study marks the next step in our efforts to combat noise-induced hearing loss (NIHL) in a high-risk population.

NIHL is a global public health risk and is an impairment resulting from irreversible damage caused to the sensitive structures and neural elements in the cochlea. A Center for Disease Control and Prevention report highlights that 24% of adults and 17% of teenagers in the United States experience hearing loss in one or both ears from exposure to occupational or recreational loud sound. NIHL has a high prevalence among firefighters who are occupationally at-risk. Globally, occupational noise exposure is responsible for 16% of disabling hearing loss (over 600 million people) with significant lifetime costs per person in the US alone. 

In the upcoming study, our collaborators will test the safety and efficacy of ReBound-delivered mild therapeutic hypothermia treatment in mitigating noise-induced hearing loss in firefighters. In collaboration with the University of Miami and South Florida fire services, we will enroll up to 116 firefighters and non-firefighter controls to undergo hypothermia treatment after several 24-hour shifts in which significant noise exposure is expected. Subjective and functional assessments of hearing function repeated over time will be performed to evaluate the protective effects of mild therapeutic hypothermia following noise exposure. 

Updates about recruitment and data collection for this study can be found on our Clinical Page and at www.clinicaltrials.gov. Sign up for our newsletter to stay up-to-date on the progress of this study and all of our research. 
If you have any questions about our therapy or our upcoming studies, please connect with us by email at info@restorear.com.