Clinical trials: Sensorineural Hearing Loss (Disorder)
Retinitis Pigmentosa, Usher Syndrome Type 2
Study to Evaluate the Efficacy Safety and Tolerability of Ultevursen in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene (Sirius)
The purpose of this study is to evaluate the efficacy 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.
- Conditions
- Retinitis Pigmentosa, Usher Syndrome Type 2, Deaf Blind, Retinal Disease
- Trial name
- NCT05158296
- Testing
- Ultevursen
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 7 people
- Sponsor
- Laboratoires Thea
Sensori-Neural Deafness, Sensorineural Hearing Loss
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant.
- Conditions
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Bilateral
- Trial name
- NCT06699797
- Testing
- Acclaim Cochlear Implant
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Envoy Medical Corporation
Sensorineural Hearing Loss
Nucleus Freedom Cochlear Implant System Pediatric Post-approval Study
The objective of this multisite study is to evaluate the performance of the Nucleus Freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.
- Trial name
- NCT00589511
- Volunteers
- 69 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss
The Effect of Sound Stimulation on Pure-tone Hearing Threshold
The purpose of this study is to investigate if sound stimulation could improve pure-tone hearing threshold. In the late 1990s, researchers discovered that acoustic stimuli slow progressive sensorineural hearing loss and exposure…
- Trial name
- NCT01184248
- Testing
- Sound stimulation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Earlogic Korea, Inc.
Sensorineural Hearing Loss, Tinnitus
Regenerative Medicine and Stem Cell-Based Interventions for Inner Ear Trauma, Tinnitus, and Sensorineural Hearing Loss
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.
- Conditions
- Sensorineural Hearing Loss, Tinnitus, Acoustic Trauma, Inner Ear Injury
- Trial name
- HEAR-RESTORE (NCT07472023)
- Testing
- Audiologic Monitoring, Investigational Regenerative Pharmacologic Therapy, Stem Cell Regenerative Therapy
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Truway Health, Inc.
Usher's Syndrome
A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B
Primary Objective: To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B Secondary Objective: To assess long-term safety and biological activity of SAR421869
- Trial name
- NCT02065011
- Testing
- Blood draw for the laboratory assessment
- Where
- 2 sites in United States, France
- Volunteers
- 9 people
- Sponsor
- Sanofi
Bone Conduction Deafness, Unilateral Deafness
Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)
The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and…
- Conditions
- Bone Conduction Deafness, Unilateral Deafness, Middle Ear Deafness, Mixed Hearing Loss
- Trial name
- NCT03281967
- Testing
- Minimally Invasive Ponto Surgery
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Oticon Medical
Sensorineural Hearing Loss, Noise Induced Hearing Loss
FX-322 in Adults With Stable Sensorineural Hearing Loss
This is a phase 2a single and repeat dose exploratory efficacy study of intratympanic FX-322 compared to placebo in healthy male and female adults with stable sensorineural hearing loss.
- Conditions
- Sensorineural Hearing Loss, Noise Induced Hearing Loss, Sudden Sensorineural Hearing Loss
- Trial name
- NCT04120116
- Testing
- FX-322 (One Dose), FX-322 (Two Doses), FX-322 (Four Doses)
- Where
- 16 sites in United States
- Volunteers
- 95 people
- Sponsor
- Frequency Therapeutics
Severe Sudden Sensorineural Hearing Loss
Efficacy of SENS 401 in Subjects With Severe or Profound Sudden Sensorineural Hearing Loss
Primary objective of the study is to assess the efficacy of SENS-401 on hearing loss in comparison to placebo at the end of the 4-week treatment period
- Trial name
- AUDIBLE-S (NCT03603314)
- Testing
- SENS-401
- Where
- 26 sites in Bulgaria, Canada and 8 more
- Volunteers
- 115 people
- Sponsor
- Sensorion
Hearing Loss, Sensorineural
Mi2000 Totally Implantable Cochlear Implant (Mi2000 TICI)
The goal of this clinical trial is to test the Mi2000 Totally Implantable Cochlear Implant in a population of candidates for a cochlear implant.
- Trial name
- NCT06459765
- Testing
- Mi2000 TICI
- Where
- 6 sites in Austria, Belgium and 2 more
- Volunteers
- 30 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Noise-induced Hearing Loss
Protective Effects of EPI-743 on Noise-Induced Hearing Loss
If effective, administration of EPI-743 should have protective effects against temporary noise-induced hearing loss.
- Trial name
- NCT02257983
- Testing
- EPI-743
- Where
- United States
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Edison Pharmaceuticals Inc
Retinitis Pigmentosa, Usher Syndrome Type 2
Study to Evaluate Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene
The purpose of this study is to evaluate the safety and tolerability of QR-421a administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene.
- Conditions
- Retinitis Pigmentosa, Usher Syndrome Type 2, Deaf Blind, Retinal Disease
- Trial name
- Stellar (NCT03780257)
- Testing
- QR-421a
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 20 people
- Sponsor
- ProQR Therapeutics
Sensorineural Hearing Loss, Low-Frequency Residual Hearing
Hearing 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 CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
- Trial name
- NCT04741048
- Testing
- CI624 Slim 20 Electrode
- Where
- United States
- Sponsor
- Cochlear
Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing…
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- Trial name
- ENHANCE (NCT06642935)
- Testing
- Totally implantable cochlear Implant
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
This study aims to evaluate the safety and efficacy of cochlear implantation for adults with bilateral sensorineural hearing loss who currently do not meet the FDA-approved indications for cochlear implantation.
- Trial name
- ACE (NCT06293482)
- Testing
- Cochlear™ Nucleus® System
- Where
- 9 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cochlear
Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)
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…
- Trial name
- CHORD (NCT05788536)
- Testing
- DB-OTO
- Where
- 17 sites in United States, Germany and 3 more
- Volunteers
- 36 people
- Sponsor
- Regeneron Pharmaceuticals
Conductive Hearing Loss, Mixed Hearing Loss
Evaluation of Sound Processor for a Transcutaneous System
A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and speech intelligibility and…
- Trial name
- NCT03374787
- Testing
- Fusion Sound Processor
- Where
- Sweden
- Volunteers
- 10 people
- Sponsor
- Oticon Medical
Sensorineural Hearing Loss
Phase I/IIa Study Evaluating Safety and Efficacy of an Intratympanic Dose of PIPE-505 in Subjects With Hearing Loss
This is a randomized, double-blind study of PIPE-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.
- Trial name
- NCT04462198
- Testing
- PIPE-505
- Where
- 8 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Contineum Therapeutics
Hearing Impairment, Sensorineural
Cochlear Response Telemetry and Hearing Preservation
The main purpose of this study is to monitor the response from the cochlea as the electrode is inserted during the operation to receive a cochlear implant.
- Trial name
- CREST (NCT03134989)
- Testing
- Cochlear implant
- Where
- Argentina
- Volunteers
- 80 people
- Sponsor
- Cochlear
Hearing Loss, Sensorineural
Standard Post Market Clinical Follow-up (PMCF) Study WSA @ HZO
The purpose of the study is to follow-up on a released low-risk device as part of standard PMCF activities
- Trial name
- NCT06700512
- Testing
- Hearing Aid Signia Pure C&G 7IX, Own Hearing Aid
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- WSAUD A/S