Clinical trials: Cochlear Implants
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
DFNB9, Cochlear Implantation
Safety, Tolerability, Efficacy of EA0010 in OTOF Patients With CI
This study will evaluate the safety, tolerability, and efficacy of EA0010 injection in patients with OTOF-related hearing loss who have already undergone cochlear implantation.
- Trial name
- NCT07752888
- Testing
- EA0010 Injection
- Where
- China
- Volunteers
- 1 people
- Sponsor
- Shanghai EmayGene Technology Co., Ltd
Hearing Loss, Cochlear
Evaluation of the Effect of a Spatial Localization Training Program on Auditory Comprehension
Hearing comprehension under complex listening conditions is considered to be the central complaint of everyday life for patients with cochlear implants. Localization is one of the cues for listening comprehension.
- Trial name
- CAudiBruit (NCT05237180)
- Testing
- spatial localisation training
- Where
- Reunion
- Volunteers
- 12 people
- Sponsor
- Centre Hospitalier Universitaire de la Réunion
Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency
Feasibility Study of Auditory Brainstem Implant in Young Children
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent.
- Conditions
- Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis
- Trial name
- NCT01850225
- Testing
- Auditory brainstem implant
- Where
- United States
- Sponsor
- House Research Institute
Cochlear Impant Children
Spatial Hearing Perception in Bilateral Cochlear Implant Children
Spatial hearing in cochlear implant (CI) users is a challenging investigation field since no studies have explored yet spatial auditory perception in three-dimensional space (3D).
- Trial name
- SPHERIC1 (NCT03738592)
- Testing
- behavioral exploration of spatial hearing performances, The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents), The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)
- Where
- 2 sites in France
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Hearing Loss, Sensorineural Hearing Loss
Non-significant Risk Study of a Cochlear Implant Headpiece
This study aims to evaluate a cochlear implant headpiece.
- Trial name
- NCT05488535
- Testing
- cochlear implant headpiece
- Where
- United States
- Volunteers
- 101 people
- Sponsor
- Advanced Bionics
Hearing Loss, Unilateral, Deafness, Unilateral
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for…
- Trial name
- PAS-SSD (NCT05318417)
- Testing
- The Cochlear™ Nucleus® Cochlear Implant (CI) System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cochlear
Cochlear Implantation
Cochlear Implants Registry in Thailand Project
The purpose of this study is to determine the outcome of cochlear implant including post operative hearing ability, developing of language, complication from cochlear implant, quality of life, and success factor of cochlear…
- Trial name
- CIRT (NCT02830659)
- Where
- 11 sites in Thailand
- Volunteers
- 1,500 people
- Sponsor
- Khon Kaen University
Hearing Loss
Littlears Auditory Questionnaire: Validation Study in CI Children
The LittlEARS Auditory Questionnaire is designed to assess the development of the auditory behavior in children during the first two (hearing) years.
- Trial name
- LittlEars (NCT00785707)
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Med-El Corporation
Cochlear Implants
Remote Care: The Future of Cochlear Implants
The purpose of this study is to see if remote programming visits for cochlear implants are possible.
- Trial name
- NCT04721327
- Testing
- remote CI programming
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Miami
Hearing Loss, Cochlear, Cytomegalovirus Congenital
Cytomegalovirus (CMV) Perilymphatic Fluid
In France, children cochlear implantation (CI) is performed 400 times per year. Causes of profound sensorineural hearing loss (SNHL) are represented by congenital malformation of the inner ear for 50 to 60%.
- Trial name
- CMVP (NCT04724265)
- Testing
- collection of sample of perilymphatic fluid during cochlear implantation
- Where
- France
- Volunteers
- 200 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cochlear Implant
Role of Diagnostic Imaging in Cochlear Implant
cochlear implant is a well accepted treatment to profound sensorineural hearing loss. Imaging provides essential information about anatomical Variants that could be riskyand should be considered by cochlear implant surgeon and…
- Trial name
- NCT04711538
- Testing
- MRI
- Where
- Egypt
- Volunteers
- 80 people
- Sponsor
- Sohag University
Hearing Loss, Genetic Disease
Auditory Restoration and Outcomes After Gene Therapy and Cochlear Implantation: a PRospective Cohort Analysis (AURORA)
This cohort study aims to explore the trends and differences in multidimensional perceptual levels of patients after cochlear implants or gene therapy, as well as to comprehensively assess the efficacy of gene therapy for…
- Conditions
- Hearing Loss, Genetic Disease, Speech Perception
- Trial name
- NCT06237790
- Where
- 6 sites in China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Eye & ENT Hospital of Fudan University
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
Cochlear Implant, Hearing Loss
Combined Electric and Acoustic Hearing (EAS) in Children and Adults
Cochlear implants are surgically implanted devices which restore the ability to hear to the hearing impaired. Improvements in surgery and electrodes have results in an increased number of adults and children who have residual…
- Trial name
- NCT05923203
- Testing
- Electric and acoustic stimulation (EAS) technology in the implanted ear(s)-this is the combination of a cochlear implant (CI) and hearing aid (HA) in the implanted ear(s)
- Where
- 4 sites in United States
- Volunteers
- 160 people, healthy volunteers welcome
- Sponsor
- Hearts for Hearing
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Iowa/Nucleus 10/10 mm and Nucleus Freedom Feasibility Study
The purpose of this study is to evaluate whether the Iowa/Nucleus 10/10 mm in one ear, in conjunction with a Nucleus Freedom implant in the other ear can provide useful binaural hearing in pediatric subjects who have bilateral…
- Trial name
- NCT00594061
- Testing
- Iowa/Nucleus 10/10 mm and Freedom Cochlear Implantation
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Bruce J Gantz
Children With Cochlear Implant
Analysis of Language and Auditory Abilities in Cochlear Implanted Children
The cochlear implant appears today as one of the best technique so as to lead the congenital deaf children to speak. However the results in terms of accurate access to language remain partial.
- Trial name
- NCT00947778
- Testing
- 3 sessions of evaluation tests, 1 training session
- Where
- France
- Volunteers
- 22 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Cochlear Implants
Longitudinal Outcomes in MED-EL Cochlear Implant Recipients Using a FLEX Electrode
This retrospective study aims at analysing data from clinical routine as anonymized data sets. The study aims at analysing clinical data from MED-EL Cochlear Implant (CI) recipients using a FLEX electrode array.
- Trial name
- LOTOS (NCT06343571)
- Where
- Germany
- Volunteers
- 2,000 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Vestibular Schwannoma, Acoustic Neuroma
Auditory Nerve Test System During Vestibular Schwannoma Resection
The Auditory Nerve Test System (ANTS) is a novel device that stimulates the auditory nerve much like a cochlear implant. The purpose of this study is to demonstrate feasibility of the ANTS during translabyrinthine surgery for…
- Conditions
- Vestibular Schwannoma, Acoustic Neuroma, Sensorineural Hearing Loss, Asymmetric Sensorineural Hearing Loss
- Trial name
- ANTS (NCT04241679)
- Testing
- Auditory Nerve Test System
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Washington University School of Medicine
CHARGE Syndrome
A Strategic Approach to Safe and Effective Cochlear Implantation in Patients With CHARGE Syndrome
This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome.
- Trial name
- NCT07320482
- Testing
- No intervention (observational study)
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Bundang Hospital