Noninvasive ear cooling for tinnitus
Noninvasive Therapeutic Hypothermia for Tinnitus
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Restorear Devices LLC Industry-sponsored |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07071480 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Miami, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.