An interventional study of Cold pack-delivered mild therapeutic hypothermia and Sham device in Tinnitus and Tinnitus, Subjective, sponsored by Restorear Devices LLC. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-09.
Sponsored by Restorear Devices LLC · Not applicable, Interventional, and Treatment
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:
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.
Tinnitus is the perception of sound in the absence of an external stimulus commonly described as ringing in the ears. Tinnitus is a highly common condition, with most individuals experiencing it at some point in their lifetime. At least 1 in 10 US adults experience chronic or disabling tinnitus [1] with a significant negative impact on quality of life, often affecting sleep, concentration, mood, and hearing ability. Tinnitus can be intermittent or constant in nature, and intensity can vary or be exacerbated by stress, noise exposure, or other factors. Currently, there is no widely applicable cure for tinnitus, and management typically includes use of sound therapy, mental health counseling, lifestyle modifications, stress management, and distraction techniques, all of which serve to mask symptoms without addressing underlying physiology. Tinnitus is associated with changes in auditory function, with hearing loss being the most associated co-morbidity in patients. However, tinnitus can also be observed in patients with audiometrically normal hearing [2, 3].
Tinnitus can have a significant deleterious effect on a person's quality of life, and there is currently no cure. State-of-the art treatment options suffer limitations and are often ineffective and complex. Most widely used tinnitus treatments focus on reducing awareness of tinnitus/masking symptoms and the impact on emotional state rather than seeking to address the underlying mechanisms of the sound generation [4]. Treatment modalities include sound therapy using environmental sounds and/or hearing aids, psychological interventions including tinnitus retraining therapy and/or cognitive behavioral therapy, somatosensory stimulation including vagus nerve stimulation and osteopathic manipulation, and distraction exercises including guided breathing and development of new hobbies. Other therapies aim to target the generation of tinnitus, including direct and indirect stimulation of the auditory cortex and/or other brain structures through neuromodulation and pharmacologics [5]. Despite the limited success of many of these treatment modalities, none have been shown to be widely applicable to manage tinnitus severity or provide a treatment for tinnitus. Further, systematic reviews have failed to demonstrate a strong evidence base for these approaches [1]. Many treatments and strategies currently in research are costly in terms of both time and resources, reducing sufferers' access or their ability to continue treatment over time. For those who do not find relief from their debilitating symptoms, and for those seeking to address secondary effects of tinnitus, there exists a need for novel treatment aimed at reducing acute tinnitus severity [6].
The investigators propose to show the efficacy of a highly accessible and translatable, non-invasive device utilizing mild therapeutic hypothermia, or MTH, to reduce tinnitus severity in participants with tinnitus. Unlike other approaches, MTH will address the physiological mechanisms of tinnitus and is easily deployable for routine use and symptom management. With support from a prior SBIR Phase I award, the investigators have designed and manufactured the headband-style device, ReBoundTM, to provide therapeutic hypothermia to the inner ear structures. Modifying temperature of the cochlea is known to influence auditory responses [7-12]. The investigators and others have shown that MTH delivered locally or systemically protects hearing function and cochlear structures against noise-induced hearing loss when compared to normothermic animals [13]. The present study builds upon strong preliminary and published results of MTH treatment in the inner ear [14, 15] and two additional new publications [16, 17].
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:
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.
This research will be highly impactful given the significant adverse effects of tinnitus, an unmet clinical need, on a broad population, and the high translational potential of MTH for reducing tinnitus symptoms.
444 studies on the registry are indexed under Tinnitus; 98 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 368 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →Restorear Devices LLC is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Subjects will receive hypothermia treatment delivered with ReBound devices, applied in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. MTH Arm will complete both Aims 1 and 2. n=20.
Device: Cold pack-delivered mild therapeutic hypothermia
Subjects will receive a sham wearable headband in a single 30 minute session in-clinic. Baseline audiometric testing and subjective tinnitus assessment will be measured prior to initiation of the treatment. Testing will be repeated immediately after treatment, and changes will be noted. Subjects in this group will also be sent home with a device to use as needed for a period of 6 months. They will be asked to complete monthly subjective surveys online assessing tinnitus severity and monitoring potential adverse events. Control Arm will complete both Aims 1 and 2. n=20.
Device: Sham device
Mild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound.
Sham headband-style device. Participants assigned to use this device will be told they are receiving therapy for 30 minutes. However, no therapy is being provided.
Visual Analog Scale (VAS) of Tinnitus Severity
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.
Time frame: 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.
Tinnitus Functional Index Adapted (TFI-Adapted)
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.
Time frame: TFI-Adapted will be given to participants in Aim 1. TFI-Adapted will be administered at baseline and 24 hours post-treatment.
Pure Tone Audiometry
PTA will be measured in Aim 1 for frequencies 250 - 8,000 Hz and high frequencies of \> 8,000 Hz.
Time frame: PTA will be measured in Aim 1 at baseline and immediately after treatment.
Distortion Product Otoacoustic Emissions (DPOAE)
DPOAE will be measured in Aim 1 for 1,500 - 10,000 Hz. DPOAEs will be recorded and analyzed using f2 tone frequencies with a fixed primary ratio (f2/f1) of 1.22, L1 = 65 dB SPL, L2 = 55 dB SPL.
Time frame: DPOAE will be measured in Aim 1 at baseline and immediately after treatment.
Auditory Brainstem Response (ABR)
Test measuring the brain's electrical activity in response to sound to assess hearing and neurological function. ABR will be recorded using 77 dB nHL. At least 2 averaged responses will be performed to ensure replicability.
Time frame: ABR will be measured in Aim 1 at baseline and immediately after treatment.
Tinnitus Pitch & Loudness Matching
Psychoacoustic measurements of each participant's tinnitus will be performed to qualify tinnitus pitch.
Time frame: Tinnitus pitch and loudness matching will be measured in Aim 1 at baseline and immediately after treatment.
Tinnitus Functional Index (TFI)
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.
Time frame: TFI will be given to participants in Aim 2. TFI will be administered monthly for 6 months post-baseline.
Tinnitus Handicap Inventory (THI)
25-item instrument used to assess the handicap experienced by the participant due to tinnitus. THI assesses functional, emotional, and catastrophic response reactions to tinnitus on a 4-point scale totaling 100, with degree of handicap increasing with score.
Time frame: The THI will be administered as part of enrollment determination and at 6 months post-baseline.
Tinnitus Therapy Use
2-question survey to collect data on the number of times the ReBound device was worn in the past month.
Time frame: This instrument will be administered monthly for 6 months post-baseline.
Adverse Event Questionnaire (AEQ)
2-question survey to collect data on any adverse event associated with use of the device.
Time frame: AEQ will be administered immediately after treatment, 24 hours post-treatment, and monthly for 6 months post-baseline.
Plan to share: No
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