Noninvasive Therapy for Tinnitus

Launched by RESTOREAR DEVICES LLC · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new, non-invasive treatment to help people who have chronic tinnitus, which is a persistent ringing or buzzing sound in the ears. The treatment uses a device called ReBound to gently cool the inner ear for 30 minutes during a single session. Researchers want to see if this mild cooling can safely reduce tinnitus symptoms right away and over a longer period of six months. Participants will use the device at home regularly and report how their symptoms change through online surveys.

To join the study, adults 18 years or older who have had continuous tinnitus for more than a month and experience it at least 75% of their waking hours may be eligible. They also need to have a mild or worse impact from their tinnitus based on a questionnaire. People with certain ear conditions, severe anxiety, or those currently using hearing aids or other tinnitus treatments won’t qualify. If accepted, participants will be randomly assigned to either receive the real cooling therapy or a sham (placebo) treatment, so researchers can compare results. This study is not yet recruiting but aims to find a safe and repeatable way to help manage tinnitus symptoms.

Gender

ALL

Eligibility 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