Trials / Enrolling By Invitation

Enrolling By InvitationNCT07472023

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

Truway Health Inner Ear Regeneration & Hearing Restoration Trial

Status: Enrolling By Invitation
Phase: EARLY_Phase 1
Study type: Interventional
Enrollment: 120 (estimated)

Sponsor: Truway Health, Inc. · Industry
Sex: All
Age: —
Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

Interventions

Type	Name	Description
OTHER	Audiologic Monitoring	Standard audiologic testing including pure-tone audiometry, speech recognition testing, tympanometry, and auditory function monitoring performed at scheduled study visits.
DRUG	Investigational Regenerative Pharmacologic Therapy	Investigational pharmacologic agents designed to support inner ear repair or protect cochlear hair cells following injury.
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.
COMBINATION_PRODUCT	Combination Regenerative Therapy	Investigational combination therapy involving regenerative pharmacologic agents and biological therapies designed to promote recovery of auditory function.

Timeline

Start date: 2026-03-08
Primary completion: 2097-03-08
Completion: 2099-03-08
First posted: 2026-03-16
Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study
FDA-regulated device study

Source: ClinicalTrials.gov record NCT07472023. Inclusion in this directory is not an endorsement.