TinnitusNCT07071480
Noninvasive Therapy for Tinnitus
A study testing Cold pack-delivered mild therapeutic hypothermia in people with Tinnitus and Tinnitus, Subjective, run by Restorear Devices LLC at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus, Tinnitus, Subjective
- What is being tested?
- Cold pack-delivered mild therapeutic hypothermia
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Suhrud M Rajguru, PhD, 801-641-8180, srajguru@restorear.com
Suhrud M Rajguru, PhD
About this study
Official title: Noninvasive Therapeutic Hypothermia for Tinnitus
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:
- Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
- Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
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.
Read the detailed description
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:
- Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
- Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
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.
- Conditions
- Tinnitus, Tinnitus, Subjective
- Being tested
- Cold pack-delivered mild therapeutic hypothermia, Sham device
- Keywords
- tinnitus, ringing, ringing in the ears, subjective tinnitus, constant tinnitus, treatment, symptom reduction, symptom management, tinnitus management, intervention
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold pack-delivered mild therapeutic hypothermiaDevice
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 deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild Therapeutic Hypothermia (MTH) Arm | Experimental | 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. Receives: Device: Cold pack-delivered mild therapeutic hypothermia |
| Control Arm | Sham comparator | 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. Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: TFI-Adapted will be given to participants in Aim 1. TFI-Adapted will be administered at baseline and 24 hours post-treatment.
Secondary outcomes (5)
Pure Tone Audiometry
PTA will be measured in Aim 1 for frequencies 250 - 8,000 Hz and high frequencies of > 8,000 Hz.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: TFI will be given to participants in Aim 2. TFI will be administered monthly for 6 months post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start24 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Restorear Devices LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Suhrud M Rajguru, PhD, Principal investigator, RestorEar Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071480
- Sponsor's protocol ID
- 20250377
- Other IDs
- 1R43DC022211-01A1
- Status last verified
- Jul 2026
- First submitted
- 8 Jul 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rincon Sabatino S, Rivero A, Sangaletti R, Dietrich WD, Hoffer ME, King CS, Rajguru SM. Targeted therapeutic hypothermia protects against noise induced hearing loss. Front Neurosci. 2024 Jan 16;17:1296458. doi: 10.3389/fnins.2023.1296458. eCollection 2023.
PubMed 38292902Rincon Sabatino S, Sangaletti R, Griswold A, Dietrich WD, King CS, Rajguru SM. Transcriptional response to mild therapeutic hypothermia in noise-induced cochlear injury. Front Neurosci. 2024 Jan 17;17:1296475. doi: 10.3389/fnins.2023.1296475. eCollection 2023.
PubMed 38298897Tamames I, King C, Huang CY, Telischi FF, Hoffer ME, Rajguru SM. Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation. Ear Hear. 2018 Jul/Aug;39(4):712-719. doi: 10.1097/AUD.0000000000000529.
PubMed 29240567Tamames I, King C, Bas E, Dietrich WD, Telischi F, Rajguru SM. A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation. Hear Res. 2016 Sep;339:32-9. doi: 10.1016/j.heares.2016.05.015. Epub 2016 May 31.
PubMed 27260269Henry KR. Hyperthermia exacerbates and hypothermia protects from noise-induced threshold elevation of the cochlear nerve envelope response in the C57BL/6J mouse. Hear Res. 2003 May;179(1-2):88-96. doi: 10.1016/s0378-5955(03)00097-2.
PubMed 12742241Watanabe F, Koga K, Hakuba N, Gyo K. Hypothermia prevents hearing loss and progressive hair cell loss after transient cochlear ischemia in gerbils. Neuroscience. 2001;102(3):639-45. doi: 10.1016/s0306-4522(00)00510-8.
PubMed 11226700Henry KR, Chole RA. Hypothermia protects the cochlea from noise damage. Hear Res. 1984 Dec;16(3):225-30. doi: 10.1016/0378-5955(84)90111-4.
PubMed 6401081Ohlemiller KK, Siegel JH. Cochlear basal and apical differences reflected in the effects of cooling on responses of single auditory nerve fibers. Hear Res. 1994 Nov;80(2):174-90. doi: 10.1016/0378-5955(94)90109-0.
PubMed 7896576Ohlemiller KK, Siegel JH. The effects of moderate cooling on gross cochlear potentials in the gerbil: basal and apical differences. Hear Res. 1992 Nov;63(1-2):79-89. doi: 10.1016/0378-5955(92)90076-y.
PubMed 1464578Liberman MC, Dodds LW. Single-neuron labeling and chronic cochlear pathology. II. Stereocilia damage and alterations of spontaneous discharge rates. Hear Res. 1984 Oct;16(1):43-53. doi: 10.1016/0378-5955(84)90024-8.
PubMed 6511672Brown MC, Smith DI, Nuttall AL. The temperature dependency of neural and hair cell responses evoked by high frequencies. J Acoust Soc Am. 1983 May;73(5):1662-70. doi: 10.1121/1.389387.
PubMed 6863743Kleinjung T, Langguth B. Avenue for Future Tinnitus Treatments. Otolaryngol Clin North Am. 2020 Aug;53(4):667-683. doi: 10.1016/j.otc.2020.03.013. Epub 2020 May 4.
PubMed 32381341Eggermont JJ, Roberts LE. The neuroscience of tinnitus: understanding abnormal and normal auditory perception. Front Syst Neurosci. 2012 Jul 11;6:53. doi: 10.3389/fnsys.2012.00053. eCollection 2012. No abstract available.
PubMed 22798948Atik A. Pathophysiology and treatment of tinnitus: an elusive disease. Indian J Otolaryngol Head Neck Surg. 2014 Jan;66(Suppl 1):1-5. doi: 10.1007/s12070-011-0374-8. Epub 2011 Dec 15.
PubMed 24533352Sheldrake J, Diehl PU, Schaette R. Audiometric characteristics of hyperacusis patients. Front Neurol. 2015 May 15;6:105. doi: 10.3389/fneur.2015.00105. eCollection 2015.
PubMed 26029161
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Therapeutic Hypothermia for Tinnitus
- ClinicalTrials.gov ID
- NCT07071480
- Acronym / sponsor ID
- 20250377
- Conditions
- Tinnitus, Tinnitus, Subjective
- Keywords
- tinnitus, ringing, ringing in the ears, subjective tinnitus, constant tinnitus, treatment, symptom reduction, symptom management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Restorear Devices LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
- Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
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.
Detailed description
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:
- Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
- Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Therapeutic Hypothermia (MTH) Arm | Experimental | Device: Cold pack-delivered mild therapeutic hypothermiaSubjects 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. |
| Control Arm | Sham comparator | Device: Sham deviceSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold pack-delivered mild therapeutic hypothermiaMild therapeutic hypothermia (cooling), delivered non-invasively to the structures of the inner ear (cochlea) for 30 minutes, using headband-style proprietary device, ReBound. | Device | Mild Therapeutic Hypothermia (MTH) Arm |
| Sham deviceSham 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. | Device | Control Arm |
Primary outcome
Visual Analog Scale (VAS) of Tinnitus Severity
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.
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)
Time frame: 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.
5 secondary outcomes
Pure Tone Audiometry
Time frame: PTA will be measured in Aim 1 at baseline and immediately after treatment.
Distortion Product Otoacoustic Emissions (DPOAE)
Time frame: DPOAE will be measured in Aim 1 at baseline and immediately after treatment.
Auditory Brainstem Response (ABR)
Time frame: ABR will be measured in Aim 1 at baseline and immediately after treatment.
Tinnitus Pitch & Loudness Matching
Time frame: Tinnitus pitch and loudness matching will be measured in Aim 1 at baseline and immediately after treatment.
Tinnitus Functional Index (TFI)
Time frame: TFI will be given to participants in Aim 2. TFI will be administered monthly for 6 months post-baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 38292902Rincon Sabatino S, Rivero A, Sangaletti R, Dietrich WD, Hoffer ME, King CS, Rajguru SM. Targeted therapeutic hypothermia protects against noise induced hearing loss. Front Neurosci. 2024 Jan 16;17:1296458. doi: 10.3389/fnins.2023.1296458. eCollection 2023.
- Background: PubMed 38298897Rincon Sabatino S, Sangaletti R, Griswold A, Dietrich WD, King CS, Rajguru SM. Transcriptional response to mild therapeutic hypothermia in noise-induced cochlear injury. Front Neurosci. 2024 Jan 17;17:1296475. doi: 10.3389/fnins.2023.1296475. eCollection 2023.
- Background: PubMed 29240567Tamames I, King C, Huang CY, Telischi FF, Hoffer ME, Rajguru SM. Theoretical Evaluation and Experimental Validation of Localized Therapeutic Hypothermia Application to Preserve Residual Hearing After Cochlear Implantation. Ear Hear. 2018 Jul/Aug;39(4):712-719. doi: 10.1097/AUD.0000000000000529.
- Background: PubMed 27260269Tamames I, King C, Bas E, Dietrich WD, Telischi F, Rajguru SM. A cool approach to reducing electrode-induced trauma: Localized therapeutic hypothermia conserves residual hearing in cochlear implantation. Hear Res. 2016 Sep;339:32-9. doi: 10.1016/j.heares.2016.05.015. Epub 2016 May 31.
- Background: PubMed 12742241Henry KR. Hyperthermia exacerbates and hypothermia protects from noise-induced threshold elevation of the cochlear nerve envelope response in the C57BL/6J mouse. Hear Res. 2003 May;179(1-2):88-96. doi: 10.1016/s0378-5955(03)00097-2.
- Background: PubMed 11226700Watanabe F, Koga K, Hakuba N, Gyo K. Hypothermia prevents hearing loss and progressive hair cell loss after transient cochlear ischemia in gerbils. Neuroscience. 2001;102(3):639-45. doi: 10.1016/s0306-4522(00)00510-8.
- Background: PubMed 6401081Henry KR, Chole RA. Hypothermia protects the cochlea from noise damage. Hear Res. 1984 Dec;16(3):225-30. doi: 10.1016/0378-5955(84)90111-4.
- Background: PubMed 7896576Ohlemiller KK, Siegel JH. Cochlear basal and apical differences reflected in the effects of cooling on responses of single auditory nerve fibers. Hear Res. 1994 Nov;80(2):174-90. doi: 10.1016/0378-5955(94)90109-0.
- Background: PubMed 1464578Ohlemiller KK, Siegel JH. The effects of moderate cooling on gross cochlear potentials in the gerbil: basal and apical differences. Hear Res. 1992 Nov;63(1-2):79-89. doi: 10.1016/0378-5955(92)90076-y.
- Background: PubMed 6511672Liberman MC, Dodds LW. Single-neuron labeling and chronic cochlear pathology. II. Stereocilia damage and alterations of spontaneous discharge rates. Hear Res. 1984 Oct;16(1):43-53. doi: 10.1016/0378-5955(84)90024-8.
- Background: PubMed 6863743Brown MC, Smith DI, Nuttall AL. The temperature dependency of neural and hair cell responses evoked by high frequencies. J Acoust Soc Am. 1983 May;73(5):1662-70. doi: 10.1121/1.389387.
- Background: PubMed 32381341Kleinjung T, Langguth B. Avenue for Future Tinnitus Treatments. Otolaryngol Clin North Am. 2020 Aug;53(4):667-683. doi: 10.1016/j.otc.2020.03.013. Epub 2020 May 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suhrud M Rajguru, PhD principal investigator
RestorEar Devices
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold pack-delivered mild therapeutic hypothermia in people with Tinnitus and Tinnitus, Subjective, run by Restorear Devices LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristine Harris (305-243-4611, keh129@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) of Tinnitus Severity (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07071480, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.