Clinical Trials for Hearing Disorders and Deafness

Source: ClinicalTrials.gov — U.S. National Library of Medicine — A database of privately and publicly funded clinical studies conducted around the world (U.S. National Library of Medicine, public domain).

This page lists clinical trials related to Hearing Disorders and Deafness from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 22
• Active, not recruiting: 5
• Completed: 14
• Other: 9

Results are refreshed periodically and may not reflect the most current information available from ClinicalTrials.gov.

Recruiting Trials

NCT03011541 — Stem Cell Ophthalmology Treatment Study II

This study will evaluate the use of autologous bone marrow derived stem cells (BMSC) for the treatment of retinal and optic nerve damage or disease.

NCT04198909 — Optimization of a Non-invasive Electrophysiological Method for Studying the Functionality of Auditory Nerve Fibers

Acoustic overexposure can induced temporary or hearing loss. Usually hearing loss is associated with cochlear cell damages. Recently, a new pathological entity was described and called “hidden hearing loss”. In animal model, the histopathology revealed a selective reduction in the number of auditory fibers, resulting in a decrease in the amplitude of wave I of the auditory brainstem response. E…

NCT04923087 — Impact of Auditory Stimulation in Eating Pleasure (EDERE 2021)

Background. Decreased taste and smell contribute to loss of appetite (anorexia), and the resulting protein-energy malnutrition increases the frailty of the elderly. The risk of falls, disability, infections and depression often requires them to be institutionalized. Elderly, undernourished and toothless patients often complain about the monotony of a soft, mixed-texture diet. In a previous stud…

NCT05451628 — Anatomy-Based Fitting in Unexperienced Cochlear Implant Users

Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI). A CI needs to be individually programmed (fitted) for each recipient. A fitting “map” is defined as a set of electrical parameters that are individually adapted to a recipien…

NCT05962359 — Neural Prediction to Enhance Language

The language outcome of children receiving cochlear implantation to address bilateral sensorineural hearing loss is more variable than that of typical hearing children. The research is focused upon development of neural predictive models based upon brain imaging to forecast language after cochlear implantation on the individual child level. The long-term goal is improving children’s language by…

NCT05788536 — A Study of DB-OTO, an Adeno-Associated Virus (AAV) Based Gene Therapy, in Children/Infants, Adolescents and Adults With Hearing Loss Due to Otoferlin Mutations

Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat pediatric and adult participants who have severe-to profound and profound hearing loss due to changes in the otoferlin gene.

The purpose of this study is to:

• Learn about the safety of DB-OTO
• Determine how well DB-OTO is tolerated (does not cause ongoing d…

NCT05775367 — Cochlear Implants in Young Children With SSD

The goal of this clinical trial is to investigate the safety and effectiveness of cochlear implantation in infants and toddlers with single-sided deafness.

The main questions it aims to answer are:

• Are cochlear implants an effective treatment of single-sided deafness in infants and toddlers?
• Are cochlear implants a safe treatment for single-sided deafness in infants and toddlers?

Partici…

NCT05582551 — Patients At Risk for Sensory Screening (HPARSS) to Enhance Sensory Deficit Screening in Childhood Cancer Survivors

The overall goal of this study is to attempt to overcome the organizational barriers that impede prompt screening for at-risk sensory deficits in childhood cancer survivors (CCS). Using a cross sectional design study, collaborators in the Informatics Research branch of the Institute of Informatics at the Washington University School of Medicine will identify CCS at risk for sensory deficits bas…

NCT07039435 — Perceptual Adaptation Following Cochlear Implantation (Aim 3a)

The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation. One of these maps will be standard of care and the other three will have higher low frequency edges than the standard of care default maps. These maps will alternate daily during the first m…

NCT06663917 — Clinical Evaluation of Frequency Allocation for Bimodal CI Users

This study will examine experienced, bimodal cochlear implant (CI) patients who receive an alternative frequency allocation table (FAT) to determine how it improves sound quality, device satisfaction, and speech perception abilities with respect to the standard default FAT. The goal of this study is to investigate how improving place-pitch mismatch in bimodal CI users affects 1) sound quality, …

NCT06627179 — Study to Evaluate Ultevursen in Subjects With Retinitis Pigmentosa (RP) Due to Mutations in Exon 13 of the USH2A Gene

The purpose of this Phase 2b study is to evaluate the safety and tolerability of ultevursen administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene. This is a multicenter Double-masked, Randomized, Sham-controlled study which will enroll 81 subjects.

NCT06789445 — A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)

Study OpCT-001-101 is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in approximately 54 adults with primary photoreceptor (PR) disease. Phase 1 focuses on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 o…

NCT06936449 — Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array

A long-term follow-up of Cochlear’s cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.

NCT06930781 — Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.

NCT05730283 — Prevention of Ototoxicity in NTM Patients Treated With IV Amikacin

The goal of this clinical trial is to test the effectiveness of the study drug, ORC-13361, in preventing hearing loss in patients with NTM infection who are undergoing treatment with IV amikacin therapy. The main question this study aims to answer is:

• Is ORC-13661 effective for preventing or lessening hearing loss induced by amikacin treatment?
• Is ORC-13661 effective for preventing or less…

NCT07287124 — A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults

This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system. The system includes a microphone placed under the skin to detect speech and sound from the environment, providing the option to hear without any visible external parts. This study will involve adults with sensorineural hearing loss, a type of hearing loss caused…

NCT07637981 — First Clinical Study to Evaluate Safety, Tolerability & PK of DX243 in Healthy Volunteers and Patients With Hearing Loss

Phase 2a: Multiple Ascending Dose (MAD) in male and female patients with hearing loss:

The study will be conducted according to a randomised, placebo-controlled, double-blind design. A total of 24 patients, otherwise healthy, aged up to 75 years old, with mild to moderate hearing loss will be included. Two cohorts of 12 male or female patients (no ratio is required) will receive two different …

NCT07407582 — Ph. I/II Sodium Thiosulfate for OtoProtection During Cisplatin (STOP-CIS)

The purpose of this study is to assess the safety and effectiveness of a drug called Pedmark® sodium thiosulfate (STS) in reducing hearing impairment with standard of care cisplatin therapy. The safety and effectiveness of STS in reducing hearing loss has been well established in children and is approved for use in the pediatric and young adult population. However, information in adult patients…

NCT07627971 — Open-label Study of SKY-GJB2 in Pediatric Subjects With GJB2-mediated Hearing Loss

Skylark Bio is conducting a study of an investigational new drug called SKY-GJB2 and its delivery device, the SKY-CAT. SKY-GJB2 is a gene therapy that is being developed to treat children who have hearing loss due to changes in the GJB2 gene (also referred to as Connexin 26). The SKY-CAT is a device that delivers the gene therapy.

The purpose of this study is to:

Learn about the safety and to…

NCT07646119 — Hidden Hearing Loss in Older Adults

The goal of this observational study is to investigate whether speech-in-noise perception deficits in older adults aged 60 years or older with objectively normal hearing thresholds are due to impaired ability of processing temporal cues in speech signals. The study further aims to examine whether cognitive and cortical mechanisms provide compensatory support for speech perception in challenging…

NCT07690670 — WhatsApp AI Support vs Paper Support for First-Time Hearing Aid Users

The purpose of this study is to advance hearing care in low- and middle-income countries (LMICs) through the rigorous evaluation and optimization of innovative interventions and technologies. This study encompasses the following key aim:

This study aims to evaluate the effectiveness of a WhatsApp-delivered AI-enabled support and acclimatization programme for adults receiving preset hearing aid…

NCT06340633 — SPI-1005 in Adults Receiving Cochlear Implant

The goal of this clinical trial is to learn about the effects of drug SPI-1005 in adults receiving a cochlear implant with a long electrode array (FLEX26 or greater) from MED-EL Cochlear Implant Systems into one ear.

The main question this clinical trial aims to answer is: Is drug SPI-1005 safe and well-tolerated in adults receiving a cochlear implant, and/or what medical problems might partic…

Active, Not Recruiting

NCT03655223 — Early Check: Expanded Screening in Newborns

Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health condi…

NCT05615649 — Expanded Indications in the Pediatric BONEBRIDGE Population

This study will assess safety and efficacy of the MED-EL BONEBRIDGE Bone Conduction Implant in children under 12 years old with conductive or mixed hearing loss.

NCT05537220 — Oral N-acetylcysteine for Retinitis Pigmentosa

Retinitis pigmentosa (RP) is an inherited retinal degeneration caused by one of several mistakes in the genetic code. Such mistakes are called mutations. The mutations cause degeneration of rod photoreceptors which are responsible for vision in dim illumination resulting in night blindness. After rod photoreceptors are eliminated, gradual degeneration of cone photoreceptors occurs resulting in …

NCT06370351 — A Phase I/II Clinical Trial With SENS-501 in Children Suffering From Severe to Profound Hearing Loss Due to Otoferlin (OTOF) Mutations

This study intends to assess safety, tolerability, and efficacy of SENS-501 in children between the ages of 6-31 months with pre-lingual hearing loss due to a mutation in the Otoferlin gene.

NCT07420751 — Assessment of Patient Experience With Auto-Captioning Glasses in NF2-Related-Schwannomatosis

The goal of this clinical trial is to investigate the usability of auto-captioning glasses for adults diagnosed with NF2-related schwannomatosis and loss of hearing. The primary objective of the study is to determine the feasibility and acceptability of auto-captioning glasses in this population.

Participants will be asked to:

• Use the glasses at their discretion for 12 weeks
• Report their …

Not Yet Recruiting

NCT07681830 — Same-Day Cochlear Implant Activation (SDA-CI)

This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard practice of activation approximately 14 days after surgery.

Adult cochlear implant recipients at Aarhus University Hospital will be randomly assigned to either same-day ac…

NCT07130136 — Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients

The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss who have a pre-existing Baha implant and Abutment (BIA300) and are transitioning to the Osia System.

The main questions this study aims to answer are:

• Is the safety …

NCT07683689 — Improving Cochlear Implant Outcomes Through Modeling and Programming Strategies Based on Human Inner Ear Pathology

Cochlear implants are devices placed in the inner ear through surgery to help people with severe to profound hearing loss. While these devices work well overall, results vary widely from person to person. Many people with cochlear implants still have trouble understanding speech in noisy places and enjoying music.

This study looks at whether customizing the way a cochlear implant is programmed…

NCT07652528 — CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial

This exploratory randomized controlled trial evaluates whether a CGM-guided temporary patch pump (CareLevo CSII) reduces glucocorticoid-induced hyperglycemia (GIH) compared to a Lantus-based basal-bolus injection (MDI) regimen in patients with sudden sensorineural hearing loss (SSNHL) and type 2 diabetes or prediabetes receiving high-dose systemic corticosteroids (methylprednisolone 48 mg/day)….

NCT07677748 — Optimization of Perceived Sound Quality for Music Listening in Hearing Aid Users With Hearing Loss.

This study aims to optimize music listening quality for 66 hearing aid users (33 musicians and 33 non-musician music enthusiasts) by developing a dedicated “Music Program” based on individual frequency preference profiles. We will evaluate the program’s efficacy by comparing listening quality and emotional response scores against standard settings, while also investigating correlations with mus…

NCT07290530 — 24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome

The goal of this clinical trial is to learn if NPI-001 works to prevent progression of retinitis pigmentosa in adults diagnosed with Usher syndrome. It will also provide information about the safety of NPI-001. The main questions it aims to answer are:

Does NPI-001 slow down the loss of photoreceptors? What medical problems do participants have when taking NPI-001? Researchers will compare NPI…

NCT07584837 — Cochlear Implantation and Social Outcomes

The goal of this clinical trial is to learn if hearing devices, like cochlear implants, affect social and cognitive function of older adults. The main questions the researchers want to answer are:

• How social are older adults with hearing loss before and after using hearing devices?
• How well do older adults with hearing loss think before and after using hearing devices?
• For older adults w…

NCT03101917 — Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)

The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less i…

Enrolling by Invitation

NCT00341874 — Genetic Analyses of Nonsyndromic and Syndromic Deafness in Pakistan

Objective: One objective of this study is to genetically map and identify mutated genes for human hereditary hearing loss. A second objective is to study the function of these genes in the auditory system using mouse models. Human hereditary hearing impairment is the result of abnormal ear development, abnormal ear function or both. Although the genes for numerous deafness loci have been mapped…

Completed Trials

NCT00023036 — Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts

This study will try to identify and understand the genetic factors that lead to an inner ear malformation called “enlarged vestibular aqueducts”, that can be associated with hearing loss.

Patients with sensorineural hearing loss with or without inner ear malformations and their parents and siblings may be eligible for this study. Participants and their immediate family members, may undergo som…

NCT00023049 — Genetic Analysis of Hereditary Disorders of Hearing and Balance

This study will try to identify the genetic causes of hereditary hearing loss or balance disorders.

People with a hearing or balance disorder that affects more than one family member may be eligible for this study. They and their immediate family members may undergo some or all of the following procedures:

• Medical and family history, including questions about hearing, balance and other ear-…

NCT01805167 — Electrophysiological Study of Interindividual Differences in Speech-understanding Among Cochlear Implant Patients

Differences in speech-understanding and the quality of the subjective perception among cochlear implant patients (Digisonic SP) depends on numerous factors. The electrical field distribution (interaction between electrodes) could also explain the disparity of the performances? The objective of our study was to quantify the influence of the electrical field interactions between the channels of s…

NCT02603081 — Study to Evaluate SPI-1005 in Adults With Meniere’s Disease

This study will evaluate the safety and efficacy of three dose levels of SPI-1005 compared to placebo on vertigo, tinnitus and sensorineural hearing loss in 40 adults with Meniere’s disease.

NCT02819856 — SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity

The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing assessments, spirometry, Pharmacokinetic (PK), Physical Exam, Adverse Events (AEs) and Labs baseline to post-treatment.

The secondary objectives of this study are to det…

NCT03686046 — Evaluation of an Open-source Speech-processing Platform

Determining acceptability and usability of a wearable open-source speech processing platform (Master Hearing Aid) developed for hearing-aid research

NCT04355689 — Safety and Efficacy of NPI-001 Tablets for RP Associated With Usher Syndrome

This study will examine the safety and efficacy of NPI-001 Tablets as compared to placebo for 24 months in subjects with vision loss due to RP associated with Usher syndrome.

NCT04929470 — Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss

This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is approved for this device. Participants receive interventions as part of routine medical care.

NCT05070429 — ACHIEVE Hearing Intervention Follow-Up Study

The ACHIEVE Hearing Intervention Follow-Up study is a randomized trial of a telehealth versus conventional clinic-based hearing healthcare (HHC) delivery model among older adults who are existing hearing aid users to determine if a telehealth HHC model improves hearing aid use and other communication outcomes compared to clinic-based HHC.

NCT04741009 — Perimodiolar Implant Performance in Adults With Low-Frequency Residual Hearing

The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI632 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.

NCT05219474 — A Computational Approach to Optimal Deactivation of Cochlear Implant Electrodes

The goal of the present study is to use computationally driven models of speech understanding in cochlear implant (CI) users to guide the search for which combination of active electrodes can yield the best speech understanding for a specific patient. It is hypothesized that model-recommended settings will result in significantly better speech understanding than standard-of-care settings.

NCT04677972 — SPI-1005 for the Treatment of Meniere’s Disease

The study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 in adult subjects with definite Meniere’s disease with active symptoms within three months preceding study enrollment.

NCT07639346 — Extended Reality Vocational Training for Hearing Impaired

This study examines the efficacy of an interactive, extended reality (XR)-based virtual training environment-specifically utilizing 360-degree virtual reality (360-VR) interactive simulations-against conventional vocational experiential methods. The primary objective is to evaluate whether integrating synchronized visual scaffolding, which combines localized Saudi Sign Language (SSL) video loop…

NCT07667140 — Standard Post Market Clinical Follow-up (PMCF) Study WSA 2026

The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities.