External Therapy for Tinnitus Management

This study is looking into a new way to help people with chronic tinnitus (ringing in the ears). It's testing a device called ReBound, which delivers mild therapeutic hypothermia (cooling) to the inner ear for 30 minutes. You might be able to join if you are an adult between 18 and 55 years old, have had subjective tinnitus for at least 30 days, and your tinnitus is constant and bothersome (Tinnitus Handicap Inventory score of 12 or higher). The main goal is to see if this cooling treatment can reduce how severe your tinnitus feels and if the device is comfortable to use. Researchers will compare results from people who get the cooling treatment to those who get a sham (fake) treatment.

Study design: This interventional study plans to enroll 80 participants. It compares a cooling device to a sham device, meaning some participants will receive the active treatment and others a placebo.
What's involved: Participants will wear either the ReBound device or a sham device for a single 30-minute session. Questionnaires will be used to measure tinnitus severity immediately before and after this session.
Compensation: Not stated in the trial record.
Follow-up: Tinnitus severity will be measured immediately prior to and immediately after treatment or sham treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

External Therapy for Tinnitus Management

Recruiting

NAAges 18–55InterventionalTreatment

Restorear Devices LLC

~80 participants

Updated 2026-07-28 on ClinicalTrials.gov

What's tested:Cold pack-delivered mild therapeutic hypothermiaSham (No Treatment)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Subjective Tinnitus Severity

Measured over Immediately prior to and immediately after treatment or sham treatment.

Conditions

Tinnitus

Tinnitus, Subjective

Where it's being run

1 sites across 1 states

Montana1

Study leadership

Suhrud Rajguru, PhD · PRINCIPAL_INVESTIGATOR · RestorEar Devices
Kendall Stern, MPH · PRINCIPAL_INVESTIGATOR · RestorEar Devices

Who to contact

Kendall Stern, MPH

[email protected]

2068187219

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Subjective Tinnitus SeverityImmediately prior to and immediately after treatment or sham treatment.
An adapted 4-question visual analog scale (VAS) will be used to assess tinnitus awareness, loudness, tolerance and disturbance before baseline treatment and repeated immediately after application using the online survey module. The VAS has been adapted to address the current, acute subjective experience of the participants' tinnitus rather than their general experience. The VAS consists of a sliding scale from 0 to 100, with 100 correlating to a greater disease burden/worse symptoms.

Trialytics