Regenerative Therapy for Hearing Loss
(HEAR-RESTORE Trial)
What You Need to Know Before You Apply
What is the purpose of this 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.
Who Is on the Research Team?
Gavin C Solomon, CEO
Principal Investigator
Truway Health, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Comprehensive otologic and audiologic evaluations including clinical history, otoscopic examination, and standardized hearing tests
Treatment
Participants receive investigational therapies including pharmacologic and/or stem cell-based approaches to support inner ear recovery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including repeat audiometric testing and tinnitus symptom scoring
What Are the Treatments Tested in This Trial?
Interventions
- Combination Regenerative Therapy
- Investigational Regenerative Pharmacologic Therapy
- Stem Cell Regenerative Therapy
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Truway Health, Inc.
Lead Sponsor
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