Using mild cooling to protect hearing after noise exposure
Official title: Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Run by Restorear Devices LLC · NCT06729632 · Data updated 2026-11-12
This study is testing whether a mild cooling device can help firefighters keep their hearing safe after being exposed to loud noise on the job.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Restorear Devices LLC Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | December 19, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | July 23, 2026 |
| Trial ID | NCT06729632 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-55 who are firefighters and fluent in English.
✕Probably not a fit
Patients with significant prior noise exposure or existing otologic conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study investigates the use of a non-invasive mild therapeutic hypothermia device to preserve hearing in individuals exposed to loud noise, specifically targeting firefighters. Participants will wear the device after their shifts for a year, and researchers will compare their hearing outcomes to a control group receiving no therapy. The study aims to establish the safety and optimal duration of the device's use while assessing its effectiveness in reducing noise-induced hearing loss. This innovative approach leverages established neuroprotective benefits of mild hypothermia to potentially safeguard cochlear structures.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of noise-induced hearing loss among at-risk populations.
How similar studies have gone: While the application of mild therapeutic hypothermia for hearing preservation is novel, prior research has shown its potential in neuroprotection.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of Miami
Miami, Florida, United States Recruiting
Study contacts
- Principal investigator: Suhrud M Rajguru, PhD — RestorEar Devices
- Study coordinator: Suhrud M Rajguru, PhD
- Email: srajguru@restorear.com
- Phone: 801-641-8180
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.