Regenerative Therapy for Hearing Loss

(HEAR-RESTORE Trial)

Age: Any Age
Sex: Any
Trial Phase: Phase < 1
Sponsor: Truway Health, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

GC

Gavin C Solomon, CEO

Principal Investigator

Truway Health, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 75 years old.
I have been diagnosed with hearing loss, tinnitus, or inner ear injury.
Hearing threshold ≥25 dB HL at one or more audiometric frequencies
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Assessment

Comprehensive otologic and audiologic evaluations including clinical history, otoscopic examination, and standardized hearing tests

1-2 weeks
1 visit (in-person)

Treatment

Participants receive investigational therapies including pharmacologic and/or stem cell-based approaches to support inner ear recovery

6 months
Regular visits for audiologic testing and symptom monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including repeat audiometric testing and tinnitus symptom scoring

6 months
Periodic visits (in-person and virtual)

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

Group I: Stem Cell Investigational TherapyExperimental Treatment1 Intervention
Group II: Regenerative Pharmacologic TherapyExperimental Treatment1 Intervention
Group III: Combination Regenerative TherapyExperimental Treatment1 Intervention
Group IV: Standard Audiologic MonitoringActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Truway Health, Inc.

Lead Sponsor