Clinical Trials for Ear Disorders

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 Ear Disorders from the ClinicalTrials.gov database.

Trial Summary

• Total studies: 50
• Recruiting: 28
• Active, not recruiting: 2
• Completed: 9
• Other: 11

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

Recruiting Trials

NCT00598351 — Natural History Study of Patients With Neurofibromatosis Type 2

Objective

With this prospective natural experiment trial on neurofibromatosis type 2 (NF2) study, we hope to understand the factors leading to tumor progression and neurological disease burden in NF2.

Study Population

A total of 269 participants, ages 8-75, with a clinical or genetic diagnosis of NF2 will participate in this study.

Design

Study participants will be evaluated with a thoroug…

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.

NCT03893643 — Cutaneous and Mucosal Manifestations of Neurofribromatosis Type 2 in Children Under 15

.Neurofibromatosis type 2 is an inherently autosomal dominant genetic disease, but cases of mosaicism or de novo mutation are not uncommon. the prevalence is estimated at 1 / 60,000. the clinical presentation is based on the appearance of tumors in the central and peripheral nervous system. The current average age of diagnosis is around 25 to 30 years depending on the studies. Currently, the di…

NCT04649242 — Randomized Study in Children and Adolescents With Migraine: Acute Treatment

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

NCT04743141 — Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to < 18 years of age).

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…

NCT04806282 — Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets

Background:

Disorders of hearing instability (HI) are poorly characterized and ineffectively treated. HI can cause fluctuations in hearing thresholds and speech understanding. Researchers want to use a specialized form of magnetic resonance imaging (MRI) and blood tests to learn more about HI.

Objective:

To characterize a cohort of people with HI and to correlate HI with other data, includin…

NCT05156398 — Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.

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…

NCT05582837 — Treatment of Meniere’s Disease With Migraine Medications

Meniere’s disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). Vertigo represents one of the most common and distressing problems in MD patients, and it causes various somatic and psychological disorders that i…

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…

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, …

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…

NCT07576582 — Peloid Therapy in Temporomandibular Joint Dysfunction

This prospective, single-group clinical study will evaluate whether local peloid therapy improves pain and jaw function in adults with temporomandibular joint dysfunction. Participants will receive peloid therapy applied to the temporomandibular joint region and masticatory muscles for 20 minutes per session, 5 days per week, for 2 weeks. Pain and functional outcomes will be measured at baselin…

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…

NCT07660250 — Vagus Nerve Stimulation for Myelopathy

The objective of this study is to generate preliminary data to establish the feasibility and effectiveness of transauricular vagus nerve stimulation (taVNS) to improve post-operative outcomes of moderate to severe degenerative cervical myelopathy (DCM)

NCT07253311 — Evaluation of Rapid Diagnostic Device for the Detection of Candida Auris

“Candida auris is an emerging fungus that can cause severe infections, particularly in hospitalized patients, and is often resistant to multiple antifungal treatments. Rapid and accurate detection of this pathogen is essential to control its spread in healthcare settings.

This study aims to evaluate the clinical performance of the NG-Test® Candida auris rapid diagnostic test (RDT), developed b…

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…

NCT07493447 — Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures

This pilot clinical study evaluates the safety and imaging performance of panitumumab-IRDye800 (pan800), a fluorescent, EGFR-targeted imaging agent - in patients undergoing neurosurgical resection of intracranial lesions.

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…

NCT06688578 — Testing Effectiveness of a Stochastic Noise Stimulator to Immediately Improve Balance and Gait

The goal of this intervention study is to determine if a new electronic stimulation device, similar to a TENS can improve balance and make walking easier in older individuals with reduced balance function. The main question aims to answer the following:

Can using the device improve walking speed in older individuals?

Participants will be asked to perform a number of tasks while wearing the de…

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

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.

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.

Not Yet Recruiting

NCT07596628 — siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars

The goal of this clinical trial is to evaluate whether small interfering RNA (siRNA) microneedle patches can improve the scar appearances of ear keloids treated with surgery. The main questions it aims to answer are:

• Do siRNA microneedle patches improve post-surgical scar appearance?
• Do siRNA microneedle patches improve keloid-related symptoms, recurrence, usability, and tolerability?

Res…

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…

NCT07665385 — Trial of Management of Chronic Tinnitus by Sound Therapy and Cognitive Behavioral Therapy

clinical trial: The main aim of this study is to compare the effectiveness of Cognitive Behavioral Therapy (CBT) and Sound Therapy, both individually and in combination, in the management of patients with chronic subjective tinnitus and to evaluate their impact on decreasing tinnitus severity, psychological wellbeing and quality of life.

Patients will be randomly divided into three groups:

• …

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 …

NCT07685171 — Wet Cupping Therapy as an Integrative Medicine Treatment for Subjective Tinnitus

Cupping therapy is an ancient complementary medicine therapy. It was a cornerstone in many ancient healing systems, including Traditional Chinese Medicine, Unani Medicine, Traditional Korean Medicine, and Islamic Medicine. Previous pilot randomized controlled trials reported promising effects of adding cupping therapy in the management of tinnitus and hearing loss. This trial aims to evaluate t…

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…

NCT07240649 — Emerging Indications for Hyperbaric Oxygen Treatment

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The re…

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…

Enrolling by Invitation

NCT07267910 — Measuring Vestibular Organ Function With Weak Alternating Current Stimulation

The goal of this clinical trial is to preliminarily evaluate the use of electrical stimulation in diagnosing disorders with the vestibular system. The main questions it aims to answer are:

• Can electrical vestibular stimulation combined with movement measurement be used to diagnose disorders of the vestibular system?
• Can electrical stimulation provide treatment or rehabilitation opportuniti…

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-…

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.

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.

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.

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.