Noninvasive ear cooling for tinnitus
Official title: Noninvasive Therapeutic Hypothermia for Tinnitus
Run by Restorear Devices LLC · NCT07071480 · Data updated 2026-11-12
This trial will try a noninvasive mild ear cooling device called ReBound to see if a single 30-minute session plus up to six months of home use reduces chronic subjective tinnitus in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Restorear Devices LLC Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Status | Recruiting |
| Started | November 24, 2025 |
| Main results expected | November 30, 2026 |
| Study ends | May 31, 2027 |
| Registry record updated | July 9, 2026 |
| Trial ID | NCT07071480 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with chronic subjective tinnitus audible at least 75% of waking hours and a Tinnitus Handicap Inventory score of 18 or higher who can read English or Spanish and attend the Miami clinic are ideal candidates.
✕Probably not a fit
People with pulsatile or intermittent tinnitus, conductive hearing loss, certain otologic diseases (e.g., Meniere's disease, acoustic neuroma), severe anxiety, temporomandibular joint disorder, or catastrophic tinnitus are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized interventional trial compares a 30-minute in-clinic application of the ReBound mild therapeutic hypothermia device to a sham device, followed by six months of at-home device use and online symptom surveys. Both objective and subjective tinnitus outcomes will be measured, including the Tinnitus Handicap Inventory and clinical assessments. Adults with chronic subjective tinnitus who meet hearing and symptom-duration criteria are randomized to active or sham therapy. Safety, repeatability, and symptom changes over six months will be tracked to determine if noninvasive inner-ear cooling provides symptomatic relief.
Why it matters
Potential benefit: If successful, the device could offer a fast, noninvasive, repeatable option to reduce tinnitus severity and improve daily functioning.
How similar studies have gone: Applying mild hypothermia to the inner ear for tinnitus is a relatively novel approach with limited prior clinical evidence, although hypothermia has been explored experimentally for inner-ear protection.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 years or older at the time of signing the consent form * Fluency in English or Spanish * Chronic subjective tinnitus for more than 30 days defined as audible at least 75% of waking hours * At least mild tinnitus, score ≥18 on the Tinnitus Handicap Inventory (THI) Exclusion Criteria: * Severe anxiety, score ≥ 15 on the Generalized Anxiety Disorder-7 (GAD-7) * Tinnitus described as non-auditory or pulsatile in nature * Catastrophic tinnitus, score ≥78 on the THI * Tinnitus that is intermittent in nature * Abnormal tympanometric findings * Presence of conductive component as characterized by air-bone gaps ≥15 dB at two or more consecutive frequencies * Otologic pathologies (including, but not limited to): acoustic neuroma/ vestibular schwannoma, chronic ear disease, Meniere's disease, documented fluctuating hearing loss, or ototoxicity * Temporomandibular joint disorder * Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions. * Active hearing aid use * Dizziness at the time of signing the consent form or at the time of starting the study protocol treatment * Adults unable to consent * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
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: Kristine Harris
- Email: keh129@med.miami.edu
- Phone: 305-243-4611
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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This trial tests whether real-time neurofeedback training can reduce distress from tinnitus in adults with bothersome symptoms.
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External mild-cooling therapy for chronic tinnitus
This test will see if wearing a mild external cooling device for 30 minutes can reduce symptoms in adults 18–55 with constant subjective tinnitus.
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This trial tests TRTL-913 versus placebo in healthy adults and in adults with tinnitus to see if it is safe, tolerable, and potentially helpful for tinnitus patients.
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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.