Noninvasive Therapy for Tinnitus
Restorear Devices LLC · with University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD) · NCT07071480
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 40
- US sites recruiting
- 1
- Study start
- November 24, 2025
- Record last updated
- July 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The goal of this interventional clinical study is to establish mild therapeutic hypothermia, delivered non-invasively to the structures of the inner ear, as a safe and repeatable therapeutic method for symptomatic relief of tinnitus. The study will assess both objective and subjective measures to address two main aims:
- Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
- Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
Participants will wear the ReBound hypothermia device for 30 minutes in a single session. Researchers will compare results from those receiving the therapy to those from a control group (sham therapy). Participants will also use the device in-home for 6 months and monitor their symptoms with online surveys.
Being studied: Cold pack-delivered mild therapeutic hypothermia; Sham device
Conditions: Tinnitus; Tinnitus, Subjective
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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
Recruiting US locations
University of Miami
Miami, FL 33136
Site contact: Suhrud M Rajguru, PhD · 801-641-8180 · srajguru@restorear.com
Study contacts (from the official record)
- Kristine Harris · 305-243-4611 · keh129@med.miami.edu
- Suhrud M Rajguru, PhD · 801-641-8180 · srajguru@restorear.com