External Therapy for Tinnitus Management

Launched by RESTOREAR DEVICES LLC · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for chronic tinnitus, which is a condition where people hear ringing or buzzing sounds in their ears without any external noise. The study will test a device that gently cools the skin to see if it helps reduce the severity of tinnitus symptoms. Participants will wear this device for 30 minutes, and researchers will compare their experiences with those of a group that receives a placebo treatment, meaning they won't be using the actual cooling device.

To qualify for the study, participants should be adults aged 18 to 55 who have had consistent tinnitus for at least 30 days and feel it significantly affects their daily life. However, those with very mild tinnitus, intermittent symptoms, or certain medical conditions will not be eligible. The goal is to find out how effective and comfortable this new treatment is for those suffering from chronic tinnitus. If you or someone you know is interested in participating, this could be a valuable opportunity to help improve tinnitus management.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults 18-55 years of age at the time of signing the informed consent form with primary complaint of tinnitus;
• • Suffering from subjective tinnitus for at least 30 days;
• • Tinnitus whose level of severity is defined by Tinnitus Handicap Inventory (THI) values ≥12,
• • Tinnitus is constant in nature (defined as audible at least 75% of waking hours).
• Exclusion Criteria:
• • Very mild tinnitus (THI values \<12);
• • Tinnitus that is intermittent in nature;
• • Tinnitus described as non-auditory or pulsatile in nature;
• • Individuals with a history of vertigo or fluctuating hearing loss, such as that related to Menière's disease, chronic otitis, vestibular neuritis, neuroma, otosclerosis cholesteatoma, or temporomandibular joint disorder;
• • Individuals with a history of extreme sensitivity to cold or heat, including individuals with a past history of frostbite or Raynaud's Syndrome.
• • Those who are currently receiving medical, pharmacologic, or therapeutic intervention for tinnitus or other otologic conditions, including sound therapy, cognitive behavioral therapy (CBT), Tinnitus Retraining Therapy (TRT), steroid injections, or other treatments;
• • Those who present with a mental health score indicating significant psychological component, per standard of care, based on PHQ-4 score of moderate to severe anxiety/depression.
• • Children (under 18 years), incarcerated individuals, adults unable to consent, and psychologically vulnerable participants.