University of Miami Miller School of Medicine researchers have begun enrolling participants in two clinical trials evaluating the potential of cooling devices to prevent hearing loss. Funded by the National Institutes of Health (NIH), the studies explore the use of targeted hypothermia to protect vulnerable parts of the ear in cochlear implant patients and firefighters exposed to high levels of occupational noise.
The first study focuses on patients undergoing cochlear implantation. "Hypothermia therapy has been shown to be very effective in neural preservation, and Dr. Rajguru, with his team, have applied this regimen to preservation of residual natural hearing during cochlear implantation surgery," said Fred Telischi M.D., the James R. Chandler Chair of the Department of Otolaryngology-Head and Neck Surgery. The trial aims to determine if cooling the cochlea during surgery can preserve existing hearing abilities in patients receiving cochlear implants. The study has both safety and efficacy arms. The safety arm will involve six patients to assess the safety of hypothermia during and after cochlear implant surgery. The efficacy arm will enroll 48 patients to evaluate whether hypothermia preserves residual hearing.
The second trial investigates the use of a different cooling device in firefighters, who are routinely exposed to loud noises. According to study principal investigator Hillary Snapp, Au.D., Ph.D., chief of audiology, this study will provide critical information on the effectiveness of hypothermia in at-risk populations. The research team plans to enroll more than 120 firefighters and compare hearing outcomes between those who receive hypothermia treatment after noise exposure and those who do not. The device, resembling over-the-ear headphones, delivers therapeutic cooling to the temple bone behind the ear.
Cooling Technology and Trial Design
The cooling technology, developed by Dr. Suhrud Rajguru, founder and chief scientific officer of RestorEar Devices, LLC, is based on the principle that therapeutic cooling can protect delicate inner ear structures from damage. Dr. Rajguru holds patents on hypothermia technologies to preserve hearing and is recipient and lead for NIH Small Business Innovation Research (SBIR) grants that funded these studies. The cochlear implant study will assess both the safety and efficacy of the cooling intervention. Six patients will be enrolled in a safety arm to evaluate any potential adverse effects of hypothermia during and after surgery. A larger efficacy arm will then enroll 48 patients to determine if the cooling treatment effectively preserves residual hearing compared to standard cochlear implantation procedures.
Significance and Potential Impact
Hearing loss affects millions of people worldwide and can significantly impact quality of life. Current treatments, such as hearing aids and cochlear implants, can help restore some hearing function, but do not always prevent further hearing loss. These trials represent a novel approach to hearing preservation by exploring the therapeutic potential of targeted cooling. If successful, these interventions could offer a non-pharmacological option for protecting hearing in vulnerable populations. Michael Hoffer, M.D., professor of otolaryngology and neurological surgery at the Miller School, added that the model has applicability for use in all types of ear trauma, including blasts, explosives and gun shots to which members of the military and police are exposed.
