Clinical trials: Deafness With a Cochlear Implant
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
Sensorineural Hearing Loss, Presbyacusis
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Rinri Therapeutics is conducting a clinical trial of a new cell therapy called Rincell-1. Rincell-1 is being developed to treat adults with neural hearing loss, either age related hearing loss or auditory neuropathy, who also…
- Conditions
- Sensorineural Hearing Loss, Presbyacusis, Auditory Neuropathy
- Trial name
- NCT07032038
- Testing
- Otic neural progenitors, cochlear implantation
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Rinri Therapeutics
Sensorineural Hearing Loss, Tinnitus
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
The purpose of this study is to investigate the degree of benefit to tinnitus symptoms by using a Totally Implantable cochlear implant (TICI) in a group of patients who have moderate-to-severe tinnitus pre-operatively.
- Trial name
- EXCITE (NCT07893860)
- Testing
- Cochlear implant
- Where
- Spain
- Volunteers
- 14 people
- Sponsor
- Cochlear
Hearing Impairment, Sensorineural
CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology
This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150.
- Trial name
- NCT05286385
- Testing
- CP1150 Sound Processor, CP1150 NF, CP1150 + FF
- Where
- Australia
- Volunteers
- 10 people
- Sponsor
- Cochlear
Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene
A Natural History Study in Pediatric Participants With Hearing Loss Due to OTOF, GJB2, or GJB2/GJB6 Mutations
This is an observational study to examine the characteristics of gene-related hearing loss in pediatric participants with biallelic otoferlin (OTOF) Mutations, Gap Junction Beta 2 (GJB2) Mutations, or Digenic GJB2/Gap Junction…
- Conditions
- Congenital Hearing Loss Secondary to Biallelic Mutations in the Otoferlin Gene (OTOF), Biallelic Mutations in the Gap Junction Beta 2 (GJB2) Gene, Digenic Mutations in GJB2/Gap Junction Beta 6 (GJB6) Genes
- Trial name
- ENSEMBLE (NCT06019481)
- Where
- 2 sites in United States
- Sponsor
- Regeneron Pharmaceuticals
Deafness
Assessment of Bimodal Contribution in Adult Cochlear Implant Users
To evaluate the combination of electric hearing through Cochlear Implant and acoustic hearing through hearing aid in bimodal users with moderate-to-severe hearing loss in the non-implanted ear.
- Trial name
- NCT02331017
- Testing
- Speech perception tests and self-rating questionnaire
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Bnai Zion Medical Center
Hearing Loss, Cochlear
Benefits From Bimodal Fittings With Cochlear Implant and Hearing Aid vs Bilateral Hearing Aids
Hearing-aid (HA) users with insufficient HA may be better helped with a "Bimodal solution" when replacing the HA with a Cochlear implant (CI) to the poorer hearing ear and a HA to the better hearing ear.
- Trial name
- NCT04919928
- Testing
- Cochlear Implant and Hearing aid in bimodal solution, Bilateral hearing aids
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- University of Southern Denmark
Tinnitus, Hearing Loss, Bilateral or Unilateral
Evaluating How a Tinnitus Implant Affects Tinnitus Loudness in Adults With Chronic Tinnitus and Varying Levels of Hearing Loss
This study will test an experimental Tinnitus Implant System that consists of a cochlear implant, sound processor and programming software.
- Conditions
- Tinnitus, Hearing Loss, Bilateral or Unilateral, Normal Hearing
- Trial name
- TINIS (NCT06641999)
- Testing
- Tinnitus Implant System
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 16 people
- Sponsor
- Cochlear
Profound Hearing Impairment
Positron Emission Tomography Imaging of Brain Reorganisation of the Central Auditory Cortex in Asymetrical Profound Deaf Patient With a Cochlear Implantation.
Our main objective is to study how the extent of reorganization of the central auditory system is related to the binaural integration in cochlear implanted subjects with asymmetric hearing loss.
- Trial name
- UniTEP (NCT03117413)
- Testing
- Positron emission tomography scan
- Where
- 2 sites in France
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Vestibular Schwannoma, Hearing Loss
Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study
Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement.
- Trial name
- NCT03745534
- Testing
- eABR
- Where
- Austria
- Volunteers
- 8 people
- Sponsor
- Christoph Arnoldner
Unilateral Severe to Profound Hearing Loss OR Bilateral Severe to Profound Hearing Loss
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing.
- Trial name
- NCT02132130
- Testing
- CGF166
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Sensorineural Hearing Loss, Bilateral
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting With or Without Synchronization
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy with synchronization between HA and CI (ABFS) to a tonotopy based fitting strategy without…
- Trial name
- NCT05898659
- Testing
- ABFnoS then ABFS (Cochlear implant), ABFS then ABFnoS (Cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Sensorineural Hearing Loss, Enlarged Vestibular Aqueduct
Genotype-phenotype Correlation of SLC26A4 in CI Patients With EVA
To explore the genotype-phenotype correlation of SLC26A4 mutations in cochlear-implanted patients with enlarged vestibular aqueduct.
- Trial name
- NCT04934605
- Testing
- Cochlear implantation
- Volunteers
- 60 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Hearing Loss
Innovations in Clinical Care of CE Approved Nucleus Cochlear Implant Recipients
This study is to evaluate new approaches to device fitting and diagnostics for cochlear implant users. The evaluation can be performed in the laboratory in an acute session or in real world environments with take-home device use…
- Trial name
- NCT05270876
- Testing
- Cochlear Implant and sound processor device fitting paradigm or diagnostic/measurement technique
- Where
- 5 sites in Australia, Belgium
- Volunteers
- 20 people
- Sponsor
- Cochlear
Vestibular Schwannoma, Hearing Loss
Intraoperative EABR for Decision Making
In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.
- Trial name
- NCT03745560
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- Christoph Arnoldner
Hearing Impairment
Evaluating a Noise Reduction Algorithm With Cochlear Implant Users
In this study, a noise reduction algorithm will be implemented in various listening situations to evaluate its effectiveness in improving speech understanding for cochlear implant users ages 12 and older.
- Trial name
- NCT05805384
- Testing
- SEDA
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health
Hearing Loss
New Algorithms to Signal Processing for Speech Enhancement in Adult Cochlear Implant Recipients.
The purpose of this clinical investigation is to develop pre-processing strategies to enhance speech and reduce noise for CI listeners.
- Trial name
- PRESENCE-MU (NCT06100393)
- Testing
- Investigational Pre-Processing Algorithm (Sub A), Cochlear Limited standard-of-care pre-processing algorithms, Investigational Pre-Processing Algorithm (Sub B)
- Where
- 2 sites in Australia
- Volunteers
- 150 people
- Sponsor
- Cochlear
Hearing Loss
Comparing the Performance of a Categorical Loudness Scaling Based Fitting With a Behavioural Fitting in Adults With a Nucleus Cochlear Implant 3 Months Post-activation
This study aims to collect data in newly implanted cochlear implant-recipients to inform future development of fitting methods to optimally and efficiently program a cochlear implant.
- Trial name
- CALOS4 (NCT05709223)
- Testing
- Categorical loudness scaling based fitting using the research fitting system., Behavioural fitting using Custom Sound Suite (CSS 6.3) Software
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 17 people
- Sponsor
- Cochlear
Hearing Impairment
Acceptance and Performance of the CP1170 Sound Processor in Experienced Adult Cochlear Implant Recipients
Acceptance and performance of the CP1170 sound processor in experienced adult cochlear implant recipients compared with the CP1150 sound processor and their current sound processor.
- Trial name
- POLAR (NCT05619575)
- Testing
- CP1170 Sound Processor, CP1150 Sound Processor
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- Cochlear