An Early Phase 1 interventional study of Audiologic Monitoring and Investigational Regenerative Pharmacologic Therapy in Sensorineural Hearing Loss, Tinnitus and Acoustic Trauma, sponsored by Truway Health, Inc.. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Truway Health, Inc. · Early Phase 1, Interventional, and Treatment
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.
Inner ear disorders are a major cause of hearing impairment worldwide and may result from a variety of causes including acoustic trauma, infections, inflammatory processes, vascular compromise, or degenerative conditions affecting the cochlea and auditory nerve. Damage to sensory hair cells within the cochlea is a common mechanism leading to sensorineural hearing loss and tinnitus. In many cases, these cells do not regenerate naturally in humans, resulting in persistent hearing impairment.
The HEAR-RESTORE study is a translational research program designed to investigate diagnostic, monitoring, and investigational therapeutic approaches for individuals experiencing inner ear injury, tinnitus, and temporary or permanent hearing loss. The study focuses on improving the understanding of cochlear injury mechanisms and evaluating potential regenerative and protective strategies that may support auditory recovery.
Participants enrolled in the study will undergo comprehensive otologic and audiologic evaluations. Baseline assessments will include a detailed clinical history, otoscopic examination, and standardized hearing tests. Audiologic evaluations will include pure-tone audiometry to determine hearing thresholds across multiple frequencies, speech recognition testing, tympanometry to evaluate middle ear pressure and compliance, and otoacoustic emissions testing to assess cochlear hair cell function. Additional neuro-auditory testing such as auditory brainstem response (ABR) testing may be performed to evaluate auditory nerve conduction and central auditory pathways.
The study may also include advanced diagnostic tools such as vestibular function testing, imaging studies of the inner ear structures, and digital symptom monitoring to assess tinnitus severity and functional hearing ability in daily environments. These assessments allow researchers to characterize patterns of hearing impairment and track changes over time.
In addition to diagnostic assessments, the study may explore investigational strategies aimed at supporting inner ear repair and auditory recovery. Research areas of interest include regenerative medicine approaches that aim to restore or protect cochlear hair cells and auditory neurons. Investigational concepts may include biological therapies designed to stimulate endogenous repair pathways, neuroprotective agents that reduce inflammatory damage in the cochlea, and emerging regenerative technologies intended to support cellular repair within the inner ear environment.
The research program may also investigate stem cell-based approaches and other regenerative biological strategies designed to promote repair of damaged auditory structures. These approaches are being explored in early-stage research as potential methods to support regeneration of cochlear hair cells or improve neural signaling in the auditory system. Any investigational therapies evaluated in this study will be assessed primarily for safety and feasibility, with careful monitoring of auditory outcomes and adverse events.
Participants may be followed longitudinally to evaluate hearing outcomes, symptom progression, and overall auditory function. Follow-up evaluations may include repeat audiometric testing, tinnitus symptom scoring, vestibular assessments, and patient-reported outcome measures. These data will allow researchers to evaluate whether investigational approaches are associated with improvements in hearing thresholds, speech recognition ability, or reductions in tinnitus severity.
The study will also collect observational data related to potential risk factors for inner ear injury, including noise exposure, environmental factors, medication history, and prior medical conditions that may affect auditory health. These data may help improve understanding of how hearing loss develops and identify populations that may benefit from early intervention.
The results of the HEAR-RESTORE study are expected to contribute to the development of improved diagnostic frameworks and future therapeutic strategies for individuals with inner ear disorders. By combining comprehensive audiologic evaluation with emerging regenerative research approaches, this program aims to advance scientific understanding of hearing restoration and support the development of new treatments for hearing loss and tinnitus.
The findings from this research may inform future clinical trials, guide development of regenerative therapies for the inner ear, and support improved clinical management of patients experiencing hearing impairment due to injury or disease affecting the auditory system.
46 studies on the registry are indexed under Hearing Loss, Noise-Induced; 10 are open to participants now.
This study's planned enrollment of 120 is above the median of 88 across 30 interventional studies indexed under Hearing Loss, Noise-Induced.
Browse Hearing Loss, Noise-Induced studies →Truway Health, Inc. is the lead sponsor of 16 studies on the registry; 16 are open to participants now.
Compared within Hearing Loss, Noise-Induced, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hearing Loss, Sensorineural. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Standard audiologic testing including pure-tone audiometry, speech recognition testing, tympanometry, and auditory function monitoring performed at scheduled study visits.
Investigational pharmacologic agents designed to support inner ear repair or protect cochlear hair cells following injury.
Investigational regenerative therapy involving stem cell-based approaches intended to support repair of cochlear hair cells and auditory neural pathways.
Investigational combination therapy involving regenerative pharmacologic agents and biological therapies designed to promote recovery of auditory function.
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.
Time frame: Baseline to 6 months
Speech Recognition Score (Word Recognition Percentage)
Speech recognition ability measured using standardized word recognition testing (e.g., NU-6 word lists). Scores range from 0-100%, with higher scores indicating better speech discrimination ability.
Time frame: Baseline to 6 months
Change in Tinnitus Functional Index (TFI) Score
Patient-reported tinnitus severity measured using the Tinnitus Functional Index (TFI). Scores range from 0-100, with higher scores indicating greater tinnitus severity. A decrease in score reflects clinical improvement.
Time frame: Baseline to 6 months
Safety and Adverse Event Monitoring
The incidence and severity of adverse events related to investigational interventions will be monitored throughout the study period. Safety outcomes will include clinical observations, audiologic findings, and any reported complications.
Time frame: Baseline through 12 months
Change in Otoacoustic Emission Response
Otoacoustic emissions will be measured to assess cochlear outer hair cell function. Changes in emission amplitude may indicate improvement or recovery of cochlear activity.
Time frame: Baseline to 6 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in this study will be made available to qualified researchers following publication of the primary results. Data sharing will comply with applicable privacy protections, institutional policies, and regulatory requirements.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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.
Data sharing details ↗ · www.truwayhealth.com
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