Truway Health Inner Ear Regeneration & Hearing Restoration Trial
| Registry | NCT07472023, acronym HEAR-RESTORE |
|---|---|
| Status | Enrolling by invitation |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 120 (Estimated) |
| Sponsor | Truway Health, Inc. (Industry) |
| Conditions | Sensorineural Hearing Loss, Tinnitus, Acoustic Trauma, Inner Ear Injury, Noise-Induced Hearing Loss, Sudden Hearing Loss, Vestibular Dysfunction |
| Interventions | Audiologic Monitoring, Investigational Regenerative Pharmacologic Therapy, Stem Cell Regenerative Therapy, Combination Regenerative Therapy (Other, drug, biological, combination product) |
| Dates | start 2026-03-08, primary completion 2097-03-08 (estimated), completion 2099-03-08 (estimated), first posted 2026-03-16, last updated 2026-03-16 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Sensorineural Hearing Loss All trials for Tinnitus All trials of Audiologic Monitoring All trials of Investigational Regenerative Pharmacologic Therapy
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard Audiologic Monitoring | Active comparator | Other: 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. |
| Regenerative Pharmacologic Therapy | Experimental | Drug: Investigational 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. |
| Stem Cell Investigational Therapy | Experimental | Biological: Stem Cell Regenerative 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. |
| Combination Regenerative Therapy | Experimental | Combination Product: 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. |
Sex: All
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
| Facility | City | Country | Status |
|---|---|---|---|
| Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016 | New York, New York | United States |