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

NCT07472023 | Enrolling By Invitation Early Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: TH-PRS-IEAR-2026-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Hearing Loss; Inner Ear Regeneration; Cochlear Hair Cell Regeneration; Audiometry; Stem Cell Therapy; Regenerative Medicine; Tinnitus Treatment; Auditory Nerve Repair; Cochlear Injury; Hearing Restoration

Outcome Measures

Primary Outcomes (1)

• Change in Pure-Tone Audiometry Hearing Threshold (dB HL)

  Change in hearing threshold levels measured in decibels hearing level (dB HL) across standard audiometric frequencies (0.25-8 kHz) using calibrated pure-tone audiometry. Lower dB HL values indicate improved auditory sensitivity.

  Baseline to 6 months

Secondary Outcomes (3)

• Speech Recognition Score (Word Recognition Percentage)

  Baseline to 6 months

• Change in Tinnitus Functional Index (TFI) Score

  Baseline to 6 months

• Safety and Adverse Event Monitoring

  Baseline through 12 months

Other Outcomes (1)

• Change in Otoacoustic Emission Response

  Baseline to 6 months

Study Arms (4)

Standard Audiologic Monitoring

ACTIVE COMPARATOR

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.

Other: Audiologic Monitoring

Regenerative Pharmacologic Therapy

EXPERIMENTAL

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.

Drug: Investigational Regenerative Pharmacologic Therapy

Stem Cell Investigational Therapy

EXPERIMENTAL

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.

Biological: Stem Cell Regenerative Therapy

Combination Regenerative Therapy

EXPERIMENTAL

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.

Combination Product: Combination Regenerative Therapy

Interventions

Audiologic Monitoring OTHER

Standard audiologic testing including pure-tone audiometry, speech recognition testing, tympanometry, and auditory function monitoring performed at scheduled study visits.

Standard Audiologic Monitoring

Investigational Regenerative Pharmacologic Therapy DRUG

Investigational pharmacologic agents designed to support inner ear repair or protect cochlear hair cells following injury.

Regenerative Pharmacologic Therapy

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.

Stem Cell Investigational Therapy

Combination Regenerative Therapy COMBINATION_PRODUCT

Investigational combination therapy involving regenerative pharmacologic agents and biological therapies designed to promote recovery of auditory function.

Combination Regenerative Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-75 years
• Clinical diagnosis of sensorineural hearing loss, tinnitus, or inner ear injury
• Hearing threshold ≥25 dB HL at one or more audiometric frequencies
• Ability to complete audiometric testing and follow study procedures
• Ability to provide informed consent

You may not qualify if:

• Active middle ear infection
• History of cochlear implant surgery
• Known retrocochlear pathology
• Participation in experimental hearing regeneration therapy within 12 months
• Known pregnancy at time of enrollment
• Any medical condition that may interfere with study participation or safety

Sponsors & Collaborators

• Truway Health, Inc.: lead

Study Sites (1)

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

New York, New York, 10016, United States

Location

Related Publications (3)

• Shi F, Edge AS. Prospects for replacement of auditory neurons by stem cells. Hear Res. 2013 Mar;297:106-12. doi: 10.1016/j.heares.2013.01.017. Epub 2013 Jan 28.

  PMID: 23370457 BACKGROUND

• Liberman MC. Noise-induced and age-related hearing loss: new perspectives and potential therapies. F1000Res. 2017 Jun 16;6:927. doi: 10.12688/f1000research.11310.1. eCollection 2017.

  PMID: 28690836 BACKGROUND

• Brigande JV, Heller S. Quo vadis, hair cell regeneration? Nat Neurosci. 2009 Jun;12(6):679-85. doi: 10.1038/nn.2311. Epub 2009 May 26.

  PMID: 19471265 BACKGROUND

Related Links

• Truway Health Inner Ear Regeneration Research Program

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Tinnitus; Hearing Loss, Noise-Induced; Hearing Loss, Sudden; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gavin C Solomon, CEO

  Truway Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is conducted as an open-label exploratory trial in which both investigators and participants are aware of the assigned interventions. Audiometric outcome measurements will follow standardized testing protocols to ensure consistent assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to parallel study arms evaluating diagnostic monitoring, regenerative medicine approaches, and investigational therapies designed to support recovery of inner ear function following injury or hearing loss. Outcomes will be compared across groups using standardized audiologic assessments.

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 16, 2026
• Study Start: March 8, 2026
• Primary Completion (Estimated): March 8, 2097
• Study Completion (Estimated): March 8, 2099
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 6 months following publication and ending 5 years after study completion.
• Access Criteria: Data requests must include a research proposal and institutional ethics approval where applicable.

Locations

US (1)