Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss

Launched by RESTOREAR DEVICES LLC · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device that uses mild cooling treatment, called therapeutic hypothermia, to help protect firefighters from hearing loss caused by loud noises during their work. The main goals are to find out if this device is safe and how long it should be used after a shift to help reduce any hearing damage. Participants will wear the cooling device after their shifts for a year, and researchers will compare their hearing results to those who do not use the device.

To join this trial, you need to be an adult between 18 and 55 years old and speak English. Some people may not be eligible, such as those with certain ear conditions or significant past exposure to loud noise that could affect hearing. If you participate, you can expect to wear the device regularly and help contribute to important research that could benefit firefighters and others exposed to loud noises in their jobs.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 18-55 years old at the time of signing the consent form
• • Fluency in English
• Exclusion Criteria:
• • Abnormal tympanometric findings
• • Abnormal pure tone audiometry from 500-8,000 Hz (Non-firefighters only)
• • Significant history of noise exposure (Non-firefighters only)
• • Temporomandibular joint disorder
• • Otologic pathologies (including, but not limited to): acoustic neuroma/vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity
• • Current recipients of medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions
• • Active hearing aid users
• • Adults unable to consent