Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss (HEAR-RESTORE)

March 11, 2026 updated by: Truway Health, Inc.

Truway Health Inner Ear Regeneration & Hearing Restoration Trial

The HEAR-RESTORE study is an exploratory clinical research program designed to evaluate new diagnostic and regenerative approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss. Inner ear disorders can result from acoustic trauma, infections, inflammation, or other conditions that affect the cochlea, auditory nerve, or vestibular system. These conditions may lead to muffled hearing, ringing in the ears (tinnitus), balance disturbances, or reduced hearing sensitivity.

The purpose of this study is to better understand how inner ear injuries develop and to evaluate potential treatments that may support hearing recovery or protect auditory function. Participants will undergo comprehensive ear and hearing evaluations including audiometry, speech recognition testing, tympanometry, and other diagnostic assessments used in audiology and otolaryngology. These tests help measure hearing thresholds, ear pressure, and auditory nerve responses.

The study may also explore emerging regenerative medicine strategies aimed at restoring inner ear function. These approaches may include investigational therapies designed to promote repair of cochlear hair cells, reduce inflammation in the inner ear, or support neural recovery in the auditory pathway. Research may include evaluation of regenerative biological therapies, stem cell-based approaches, and other experimental technologies intended to support recovery of hearing or reduce symptoms such as tinnitus.

Participants will be monitored over time to assess hearing outcomes, safety, and changes in auditory function. Study assessments may include repeat audiology tests, imaging studies, symptom questionnaires, and other clinical measurements used to track hearing health.

The results of this research may contribute to improved diagnostic methods and potential future treatments for individuals with hearing loss or inner ear disorders.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Inner ear disorders are a major cause of hearing impairment worldwide and may result from a variety of causes including acoustic trauma, infections, inflammatory processes, vascular compromise, or degenerative conditions affecting the cochlea and auditory nerve. Damage to sensory hair cells within the cochlea is a common mechanism leading to sensorineural hearing loss and tinnitus. In many cases, these cells do not regenerate naturally in humans, resulting in persistent hearing impairment.

The HEAR-RESTORE study is a translational research program designed to investigate diagnostic, monitoring, and investigational therapeutic approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss. The study focuses on improving the understanding of cochlear injury mechanisms and evaluating potential regenerative and protective strategies that may support auditory recovery.

Participants enrolled in the study will undergo comprehensive otologic and audiologic evaluations. Baseline assessments will include a detailed clinical history, otoscopic examination, and standardized hearing tests. Audiologic evaluations will include pure-tone audiometry to determine hearing thresholds across multiple frequencies, speech recognition testing, tympanometry to evaluate middle ear pressure and compliance, and otoacoustic emissions testing to assess cochlear hair cell function. Additional neuro-auditory testing such as auditory brainstem response (ABR) testing may be performed to evaluate auditory nerve conduction and central auditory pathways.

The study may also include advanced diagnostic tools such as vestibular function testing, imaging studies of the inner ear structures, and digital symptom monitoring to assess tinnitus severity and functional hearing ability in daily environments. These assessments allow researchers to characterize patterns of hearing impairment and track changes over time.

In addition to diagnostic assessments, the study may explore investigational strategies aimed at supporting inner ear repair and auditory recovery. Research areas of interest include regenerative medicine approaches that aim to restore or protect cochlear hair cells and auditory neurons. Investigational concepts may include biological therapies designed to stimulate endogenous repair pathways, neuroprotective agents that reduce inflammatory damage in the cochlea, and emerging regenerative technologies intended to support cellular repair within the inner ear environment.

The research program may also investigate stem cell-based approaches and other regenerative biological strategies designed to promote repair of damaged auditory structures. These approaches are being explored in early-stage research as potential methods to support regeneration of cochlear hair cells or improve neural signaling in the auditory system. Any investigational therapies evaluated in this study will be assessed primarily for safety and feasibility, with careful monitoring of auditory outcomes and adverse events.

Participants may be followed longitudinally to evaluate hearing outcomes, symptom progression, and overall auditory function. Follow-up evaluations may include repeat audiometric testing, tinnitus symptom scoring, vestibular assessments, and patient-reported outcome measures. These data will allow researchers to evaluate whether investigational approaches are associated with improvements in hearing thresholds, speech recognition ability, or reductions in tinnitus severity.

The study will also collect observational data related to potential risk factors for inner ear injury, including noise exposure, environmental factors, medication history, and prior medical conditions that may affect auditory health. These data may help improve understanding of how hearing loss develops and identify populations that may benefit from early intervention.

The results of the HEAR-RESTORE study are expected to contribute to the development of improved diagnostic frameworks and future therapeutic strategies for individuals with inner ear disorders. By combining comprehensive audiologic evaluation with emerging regenerative research approaches, this program aims to advance scientific understanding of hearing restoration and support the development of new treatments for hearing loss and tinnitus.

The findings from this research may inform future clinical trials, guide development of regenerative therapies for the inner ear, and support improved clinical management of patients experiencing hearing impairment due to injury or disease affecting the auditory system.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Adults aged 18-75 years

Clinical diagnosis of sensorineural hearing loss, tinnitus, or inner ear injury

Hearing threshold ≥25 dB HL at one or more audiometric frequencies

Ability to complete audiometric testing and follow study procedures

Ability to provide informed consent

Exclusion Criteria

Active middle ear infection

History of cochlear implant surgery

Known retrocochlear pathology

Participation in experimental hearing regeneration therapy within 12 months

Known pregnancy at time of enrollment

Any medical condition that may interfere with study participation or safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Audiologic Monitoring
Participants will undergo comprehensive audiologic evaluation and monitoring including pure-tone audiometry, speech recognition testing, tympanometry, and other standard diagnostic assessments used in otolaryngology. This arm serves as the standard-of-care comparison group for evaluating hearing outcomes.
Other: Audiologic Monitoring
Standard audiologic testing including pure-tone audiometry, speech recognition testing, tympanometry, and auditory function monitoring performed at scheduled study visits.
Experimental: Regenerative Pharmacologic Therapy
Participants will receive investigational pharmacologic therapies designed to support inner ear recovery or protect cochlear hair cells following injury. Audiologic testing and symptom monitoring will be performed throughout the study period to evaluate hearing outcomes and safety.
Drug: Investigational Regenerative Pharmacologic Therapy
Investigational pharmacologic agents designed to support inner ear repair or protect cochlear hair cells following injury.
Experimental: Stem Cell Investigational Therapy
Participants will receive investigational regenerative medicine therapies involving stem cell-based approaches intended to support repair of inner ear structures or auditory nerve pathways. Audiometric and clinical monitoring will be conducted to evaluate safety and potential improvements in auditory function.
Biological: Stem Cell Regenerative Therapy
Investigational regenerative therapy involving stem cell-based approaches intended to support repair of cochlear hair cells and auditory neural pathways.
Experimental: Combination Regenerative Therapy
Participants will receive a combination of investigational regenerative strategies designed to support auditory recovery following inner ear injury. These approaches may include pharmacologic regenerative agents combined with biological or cellular therapies. Participants will undergo comprehensive hearing assessments throughout the study.
Combination product: Combination Regenerative Therapy
Investigational combination therapy involving regenerative pharmacologic agents and biological therapies designed to promote recovery of auditory function.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pure-Tone Audiometry Hearing Threshold (dB HL)
Time Frame: Baseline to 6 months
Change in hearing threshold levels measured in decibels hearing level (dB HL) across standard audiometric frequencies (0.25-8 kHz) using calibrated pure-tone audiometry. Lower dB HL values indicate improved auditory sensitivity.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speech Recognition Score (Word Recognition Percentage)
Time Frame: Baseline to 6 months
Speech recognition ability measured using standardized word recognition testing (e.g., NU-6 word lists). Scores range from 0-100%, with higher scores indicating better speech discrimination ability.
Baseline to 6 months
Change in Tinnitus Functional Index (TFI) Score
Time Frame: Baseline to 6 months
Patient-reported tinnitus severity measured using the Tinnitus Functional Index (TFI). Scores range from 0-100, with higher scores indicating greater tinnitus severity. A decrease in score reflects clinical improvement.
Baseline to 6 months
Safety and Adverse Event Monitoring
Time Frame: Baseline through 12 months
The incidence and severity of adverse events related to investigational interventions will be monitored throughout the study period. Safety outcomes will include clinical observations, audiologic findings, and any reported complications.
Baseline through 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Otoacoustic Emission Response
Time Frame: Baseline to 6 months
Otoacoustic emissions will be measured to assess cochlear outer hair cell function. Changes in emission amplitude may indicate improvement or recovery of cochlear activity.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Truway Health, Inc.

Investigators

  • Principal Investigator: Gavin C Solomon, CEO, Truway Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2026

Primary Completion (Estimated)

March 8, 2097

Study Completion (Estimated)

March 8, 2099

Study Registration Dates

First Submitted

March 8, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH-PRS-IEAR-2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the results reported in this study will be made available to qualified researchers following publication of the primary results. Data sharing will comply with applicable privacy protections, institutional policies, and regulatory requirements.

IPD Sharing Time Frame

Beginning 6 months following publication and ending 5 years after study completion.

IPD Sharing Access Criteria

Data requests must include a research proposal and institutional ethics approval where applicable.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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