Noninvasive Therapy for Tinnitus

NCT07071480 | Recruiting FDA Device

• 2 other identifiers: 202503771R43DC022211-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. The study will assess both objective and subjective measures to address two main aims:

1. 1.Ascertain the benefits of mild therapeutic hypothermia for symptomatic relief of chronic tinnitus in participants using the ReBound hypothermia device.
2. 2.Ascertain the benefits of mild therapeutic hypothermia for symptom management in chronic tinnitus participants over six months using the ReBound device.

Conditions

Tinnitus; Tinnitus, Subjective

Keywords

tinnitus; ringing; ringing in the ears; subjective tinnitus; constant tinnitus; treatment; symptom reduction; symptom management; tinnitus management; intervention

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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 at baseline and immediately after treatment.

• Distortion Product Otoacoustic Emissions (DPOAE)

  DPOAE will be measured in Aim 1 at baseline and immediately after treatment.

• Auditory Brainstem Response (ABR)

  ABR will be measured in Aim 1 at baseline and immediately after treatment.

• Tinnitus Pitch & Loudness Matching

  Tinnitus pitch and loudness matching will be measured in Aim 1 at baseline and immediately after treatment.

• Tinnitus Functional Index (TFI)

  TFI will be given to participants in Aim 2. TFI will be administered monthly for 6 months post-baseline.

Other Outcomes (3)

• Tinnitus Handicap Inventory (THI)

  The THI will be administered as part of enrollment determination and at 6 months post-baseline.

• Tinnitus Therapy Use

  This instrument will be administered monthly for 6 months post-baseline.

• Adverse Event Questionnaire (AEQ)

  AEQ will be administered immediately after treatment, 24 hours post-treatment, and monthly for 6 months post-baseline.

Study Arms (2)

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.

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.

Device: Sham device

Interventions

Sham device DEVICE

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.

Control Arm

Cold pack-delivered mild therapeutic hypothermia 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.

Mild Therapeutic Hypothermia (MTH) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator
• Restorear Devices LLC: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Related Publications (17)

• 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.

  PMID: 38292902 BACKGROUND

• Rincon 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.

  PMID: 38298897 BACKGROUND

• Tamames 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.

  PMID: 29240567 BACKGROUND

• Tamames 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.

  PMID: 27260269 BACKGROUND

• Henry 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.

  PMID: 12742241 BACKGROUND

• Watanabe 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.

  PMID: 11226700 BACKGROUND

• Henry 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.

  PMID: 6401081 BACKGROUND

• Ohlemiller 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.

  PMID: 7896576 BACKGROUND

• Ohlemiller 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.

  PMID: 1464578 BACKGROUND

• Liberman 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.

  PMID: 6511672 BACKGROUND

• Brown 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.

  PMID: 6863743 BACKGROUND

• Kleinjung 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.

  PMID: 32381341 BACKGROUND

• Eggermont 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.

  PMID: 22798948 BACKGROUND

• Atik 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.

  PMID: 24533352 BACKGROUND

• Sheldrake 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.

  PMID: 26029161 BACKGROUND

• Sanchez TG, Medeiros IR, Levy CP, Ramalho Jda R, Bento RF. Tinnitus in normally hearing patients: clinical aspects and repercussions. Braz J Otorhinolaryngol. 2005 Jul-Aug;71(4):427-31. doi: 10.1016/s1808-8694(15)31194-0. Epub 2005 Dec 15.

  PMID: 16446955 BACKGROUND

• Baguley D, McFerran D, Hall D. Tinnitus. Lancet. 2013 Nov 9;382(9904):1600-7. doi: 10.1016/S0140-6736(13)60142-7. Epub 2013 Jul 2.

  PMID: 23827090 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suhrud M Rajguru, PhD

  RestorEar Devices

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suhrud M Rajguru, PhD

CONTACT

801-641-8180; srajguru@restorear.com

Curtis S King

CONTACT

406-414-6278; cking@restorear.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 17, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)