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

Part of paid clinical trials in New York, New York.

Sponsor
Truway Health, Inc.
Study ID
NCT07472023
Phase
EARLY_PHASE1
Status
Enrolling By Invitation

Conditions

  • Acoustic Trauma
  • Inner Ear Injury
  • Noise-Induced Hearing Loss
  • Sensorineural Hearing Loss
  • Sudden Hearing Loss
  • Tinnitus
  • Vestibular Dysfunction

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Audiologic Monitoring — OTHER
    Standard audiologic testing including pure-tone audiometry, speech recognition testing, tympanometry, and auditory function monitoring performed at scheduled study visits.
  • Investigational Regenerative Pharmacologic Therapy — DRUG
    Investigational pharmacologic agents designed to support inner ear repair or protect cochlear hair cells following injury.
  • Stem Cell Regenerative Therapy — BIOLOGICAL
    Investigational regenerative therapy involving stem cell-based approaches intended to support repair of cochlear hair cells and auditory neural pathways.
  • Combination Regenerative Therapy — COMBINATION_PRODUCT
    Investigational combination therapy involving regenerative pharmacologic agents and biological therapies designed to promote recovery of auditory function.

Study Details

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.

Key Dates

Start date
Mar 8, 2026
Status verified
Mar 2026
Primary completion
Mar 8, 2097
Completion
Mar 8, 2099

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Change in Pure-Tone Audiometry Hearing Threshold (dB HL) [ Time Frame: Baseline to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Truway Health, Inc. , View 34, 401 E 34th Street, S11P, New York, NY 10016New YorkNew York10016-

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

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