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ENROLLING BY INVITATION
NCT07472023
EARLY_PHASE1

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

Sponsor: Truway Health, Inc.

View on ClinicalTrials.gov

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.

Official title: Truway Health Inner Ear Regeneration & Hearing Restoration Trial

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-03-08

Completion Date

2099-03-08

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

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.

Locations (1)

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

New York, New York, United States