Clinical trials: Cochlear
Congenital Hearing Loss, Bilateral Cochlear Implants
Investigating the Neural Oscillatory Features for Limited Access to Oral Language in Deaf Children With Early Bilateral Cochlear Implantation
Children with severe-to-profound congenital hearing loss often experience significant language development challenges. While cochlear implants (CIs) can restore auditory input, outcomes vary widely, even among those who receive…
- Trial name
- ICO (NCT07739433)
- Volunteers
- 150 people
- Sponsor
- Institut Pasteur
Cochlear Implantation, Sensorineural Hearing Loss
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in…
- Trial name
- LORIS (NCT07697911)
- Testing
- Transfer of data of SONATA 2 cochlear implant recipients
- Where
- 2 sites in Spain
- Volunteers
- 200 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Cochlear Hearing Loss
Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors
The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new…
- Trial name
- NCT03288753
- Testing
- Satisfaction questionnaire, Speech intelligibility in quiet, Speech intelligibility in noise
- Where
- 9 sites in France
- Volunteers
- 98 people
- Sponsor
- Oticon Medical
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
Cochlear Implants
Investigating the Performance and Safety of the AudioKey 3, a Device That Provides Remote Control Options and Status Information for Compatible MED-EL Audio Processors, by Analyzing Data Logged by the App and Responses to a User Survey
Investigating the performance and safety of the AudioKey 3, a device that provides remote control options and status information for compatible MED-EL audio processors, by analyzing data logged by the app and responses to a user…
- Trial name
- NCT06817928
- Where
- Austria
- Volunteers
- 46 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral
Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids
This study will evaluate sound quality and user satisfaction with Bluetooth streaming using a new bimodal streaming option for individuals who use a MED-EL cochlear implant and Starkey hearing aid.
- Conditions
- Hearing Loss, Sensorineural, Sensorineural Hearing Loss, Bilateral, Cochlear Implant Recipients, Asymmetric Hearing Loss
- Trial name
- NCT07028619
- Testing
- Bimodal Streaming Configuration
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Med-El Corporation
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
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
iotaSOFT Pediatric Study
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
- Trial name
- NCT06106373
- Testing
- iotaSOFT Insertion System
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- iotaMotion, Inc.
Hearing Loss, Sensorineural
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults
The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor
- Trial name
- SME (NCT03007472)
- Testing
- CI532, Nucleus 7
- Where
- 10 sites in United States
- Volunteers
- 96 people
- Sponsor
- Cochlear
Hearing Loss, Cochlear, Cochlear Implantation
Post-Market Clinical Investigation of the IotaSOFT Insertion System
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
- Conditions
- Hearing Loss, Cochlear, Cochlear Implantation, Hearing Loss, Sensorineural
- Trial name
- ACE (NCT06664697)
- Testing
- Cochlear Implantation with Robotic-Assisted Insertion System
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- iotaMotion, Inc.
Hearing Loss
Usability of the CP950 Sound Processor
Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.
- Trial name
- C950 (NCT02727842)
- Testing
- CP950 Sound Processor, Wireless programming pod
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Cochlear
Severe to Profound Hearing Loss
Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants.
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized.
- Trial name
- BELPS (NCT07777562)
- Testing
- Cochlear implantation
- Where
- Switzerland
- Volunteers
- 700 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
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
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
Hearing Loss
Bilateral Cochlear Implantation in Children With the MED-EL Cochlear Implant
The purpose of this study is to evaluate and document longitudinal efficacy in young children implanted bilaterally with MED-EL COMBI 40+ / PULSARCI100/SONATATI100 cochlear implant systems.
- Trial name
- NCT00784043
- Testing
- Cochlear Implant
- Where
- 9 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Med-El Corporation
Hearing Loss
Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant. Subjects older than 5 years will be included.
- Trial name
- NCT05476328
- Testing
- SPACE, OPAL-SPACE, ACE
- Where
- 5 sites in Australia, Belgium
- Volunteers
- 8 people
- Sponsor
- Cochlear
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, Sensorineural, Cochlear Implantation
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
- Trial name
- AIMBOT (NCT06664710)
- Testing
- iotaSOFT Insertion System with AIM, iotaSOFT Insertion System with AIM Control
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- iotaMotion, Inc.