Noninvasive Therapy for Tinnitus with ReBound Device

This study is testing a new way to help people with chronic tinnitus (ringing in the ears) using a device called ReBound. This device delivers mild therapeutic hypothermia (cooling) to the inner ear for 30 minutes. Researchers want to see if this cooling can reduce tinnitus symptoms right away and over six months. You might be able to join if you are an adult aged 18 or older, speak English or Spanish, and have had chronic tinnitus for more than 30 days that is at least mild. The study will measure your tinnitus severity using scales like the Visual Analog Scale (VAS) and the Tinnitus Functional Index Adapted (TFI-Adapted). The study is currently unclear about its recruitment status.

Study design: This study plans to enroll 40 participants and is interventional, meaning participants will receive either the ReBound device or a sham (inactive) device.
What's involved: You would wear the ReBound device or a sham device for 30 minutes in a single session. You would also complete questionnaires at baseline, immediately after treatment, 24 hours post-treatment, and monthly for six months.
Compensation: Not stated in the trial record.
Follow-up: Your tinnitus symptoms will be followed for up to six months after the treatment session.

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

Noninvasive Therapy for Tinnitus

Recruiting

NAAges 18+InterventionalTreatment

Restorear Devices LLC

~40 participants

Updated 2026-07-09 on ClinicalTrials.gov

What's tested:Cold pack-delivered mild therapeutic hypothermiaSham device

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Visual Analog Scale (VAS) of Tinnitus Severity

Measured over VAS will be given to participants in both Experimental and Sham Arms. For Aim 1, VAS will be administered at baseline, immediately after treatment, and at 24 hours post-treatment. For Aim 2, VAS will be administered monthly for 6 months post-baseline.

+1 more outcome measured

Conditions

Tinnitus

Tinnitus, Subjective

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Suhrud M Rajguru, PhD · PRINCIPAL_INVESTIGATOR · RestorEar Devices

Who to contact

Kristine Harris

[email protected]

305-243-4611

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

Visual Analog Scale (VAS) of Tinnitus SeverityVAS will be given to participants in both Experimental and Sham Arms. For Aim 1, VAS will be administered at baseline, immediately after treatment, and at 24 hours post-treatment. For Aim 2, VAS will be administered monthly for 6 months post-baseline.
3-item instrument used to assess participant's subjective perception of tinnitus. Includes sliding scales used by participants to score their perceived disease severity. VAS will be used to assess perceived tinnitus severity before baseline treatment and repeated immediately after treatment. The VAS consists of a sliding scale from 0 to 10, with 10 correlating to a greater disease burden/worse symptoms.
Tinnitus Functional Index Adapted (TFI-Adapted)TFI-Adapted will be given to participants in Aim 1. TFI-Adapted will be administered at baseline and 24 hours post-treatment.
25-item instrument with eight subscales; (1) Intrusiveness, (2) Sense of control, (3) Cognition, (4) Sleep, (5) Auditory, (6) Relaxation, (7) Quality of life, and (8) Emotional distress. Each subscale can be scored separately, allowing for relevant items to be summed and weighted for analysis. TFI questions will be adapted to ask participants about their tinnitus experience over the past 24 hours.

Trialytics