Clinical trials: Cochlear
Deafness; Perception
Programming Cochlear Implant With Artificial Intelligence
This thesis project proposes to investigate the "state of the art" of the programming of the cochlear implant. In the center of audiophonologie Brussels, the classic 'manual programming' has been in use over 20 years and also the…
- Trial name
- CI_AI (NCT03700268)
- Testing
- Manual intervention to programme Cochlear Implant electrodes
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sensorineural Hearing Loss, Bilateral, Cochlear Implants
Feasibility of the Mi2000 Totally Implantable Cochlear Implant in Severely to Profoundly Deaf Adults.
This clinical investigation aims to collect data on the use of the Mi2000 system, a totally implantable cochlear implant system, for the first time in human subjects.
- Trial name
- TICI (NCT04571333)
- Testing
- Mi2000 Totally Implantable Cochlear Implant
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Structure Cochlea, Temporal Envelope Cochlea
Study of the Fine Structure and Temporal Envelope of the Human Cochlea in Response to Human Vocalizations
In humans, surface electrophysiological recordings of the cochlear nerve in response to a sound stimulus provide information about the cochlear's ability to encode sound.
- Trial name
- CosySpeech (NCT06499584)
- Testing
- near field recording of human auditory nerve activity during retro sigmoid approach with contact electrode
- Where
- France
- Volunteers
- 20 people
- Sponsor
- CHU de Reims
Hearing Loss, Stress
ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Trial
The purpose of the proposed pilot randomized controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a videoconferencing-based individual Acceptance and Commitment Therapy (ACT)…
- Conditions
- Hearing Loss, Stress, Depression, Anxiety
- Trial name
- NCT07278947
- Testing
- ACT-based parenting program+usual care, Usual care
- Volunteers
- 64 people
- Sponsor
- Second Xiangya Hospital of Central South University
Hearing Impaired Children
Outcomes of Cochlear Implantation in Pediatrics
The cochlear implant (CI) is the most important progress in the treatment for adults and children with severe to profound bilateral sensorineural hearing loss who do not receive adequa¬te benefit from hearing aids and making…
- Trial name
- NCT04092231
- Testing
- Early speech perception test
- Volunteers
- 30 people
- Sponsor
- Amira Mohmed Ahmed Bakr
Hearing Loss, Sensorineural, Hearing Loss, Cochlear
Usability of the Intracochlear Catheter INCAT - a Feasibility Study
This is a feasibility study for a inner ear catheter which will be used to apply steroids to the inner ear. It will be used on nearly deaf patients during their surgery, when they receive an implant that will restore the hearing.
- Trial name
- INCAT (NCT06218966)
- Testing
- intracochlear catheter
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Sunnybrook Health Sciences Centre
Hearing Loss
Comparison of the New Fitting Method Cochlear Nucleus Fitting Software (NFS) With the Established Fitting Method Cochlear Nucleus Custom SoundTM Suite (CSS)
The purpose of this study is to evaluate if the new and simplified fitting method with Cochlear Nucleus Fitting Software (a major component of a suite of tools which form the Clinical Care Innovation) provides Cochlear Implants…
- Trial name
- NCT02228148
- Testing
- NFS, CSS
- Where
- 3 sites in Germany, Switzerland
- Volunteers
- 48 people
- Sponsor
- Cochlear
Deafness
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.
- Trial name
- NCT07683689
- Testing
- Everyday Clinical Listening Program (Control), ENI-Based Experimental Program 1, ENI-Based Experimental Program 2
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Massachusetts Eye and Ear Infirmary
Hearing Loss, Sensorineural, Bilateral
Evaluate Audiological Outcome of Cochlear Implant Program in Sohag University Hospital
Evaluation of the outcome of cochlear implantation (CI) is very important issue since adequate hearing is linked to improved communication outcomes and school performance, development of speech and language, enhances speech…
- Trial name
- NCT04719728
- Testing
- Aided pure tone audiometry
- Volunteers
- 100 people
- Sponsor
- Sohag University
Cochlear Implants, Cochlear Implantation
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
The goal of this interventional clinical study is to investigate the use of mild therapeutic hypothermia for preservation of residual hearing in cochlear implant surgery. The main questions the trial aims to answer are: 1.
- Conditions
- Cochlear Implants, Cochlear Implantation, Hearing Loss
- Trial name
- NCT06375278
- Testing
- Intra-Ear Canal Cooling Catheter
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Restorear Devices LLC
Vestibulopathy, Moderate to Severe Hearing Loss
A Study to Evaluate the Safety and Performance of a Vestibular Implant in Adults to Provide Balance Restoration
The main aim of this study is to understand if an experimental vestibular implant system can improve balance performance. The system consists of a vestibular implant combined with a cochlear implant sound processor and…
- Conditions
- Vestibulopathy, Moderate to Severe Hearing Loss, Normal Hearing, Balance Deficits
- Trial name
- BionicVEST2 (NCT06805175)
- Testing
- vestibular implant
- Where
- 3 sites in Belgium, Spain
- Volunteers
- 18 people
- Sponsor
- Cochlear
Cochlear Hearing Loss
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.
- Trial name
- NCT06301581
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Advanced Bionics AG
Deafness
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation
An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it.
- Trial name
- PSIC-TSA (NCT04663022)
- Testing
- Dunn's sensory profile questionnaire
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Toulouse
Hearing Loss, Deafness
Auditory-Cognitive Training to Optimize Outcomes for Older CI Users
The proposed study will investigate whether an auditory brain training program can improve cochlear implant (CI) outcomes in older post-lingually deafened CI users.
- Trial name
- ARCog (NCT05176561)
- Testing
- Auditory-Cognitive Training, Non-auditory Cognitive Training
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Gallaudet University
Cochlear Hearing Loss
Robotic and Manual Cochlear Implantation: An Intra-individual Study of Speech Recognition and Electrode Holder Position (ICRobMan)
Cochlear implantation (CI) allows rehabilitation for patients with severe to profound hearing impairment. Although the use of a robotic assistant provides technical assistance to the surgeon, the assessment of the impact of its…
- Trial name
- ICRobMan (NCT06235073)
- Where
- France
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University Hospital, Brest
Hearing Loss, Sensorineural, Cochlear Implant
Remote Support for Cochlear Implant Recipients: Evaluation of the HearCare MED-EL App
This clinical investigation intends to assess safety and performance of the HearCare MED-EL App, a remote care option for recipients of MED-EL cochlear implants
- Trial name
- HCARE (NCT06543953)
- Testing
- HearCare MED-EL App
- Where
- 3 sites in Germany
- Volunteers
- 120 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Deafness
Benefit of Connected Care for Cochlear Implant Management
Some 30 hospitals in France are accredited to manage cochlear implant (CI) activity, which represents around 1,800 new patients implanted per year and an estimated active file of over 20,000 patients.
- Trial name
- Connect IC (NCT07117968)
- Testing
- Standard-of-care, Experimental hybrid care pathway
- Volunteers
- 130 people
- Sponsor
- Hospices Civils de Lyon
Cochlear Implantation
Follow-up of Cochlear Implanted Children at 3 Years : Comparison of Electrophysiological and Speech-language Results
The objective of the study is to compare the responses recorded with automated cortical auditory evoked potentials, of children who had one or two cochlear implants for 3 years, and the results of the speech therapy assessment.
- Trial name
- ImplantHear3 (NCT04192968)
- Testing
- Cortical auditory evoked potentials, Additional exams
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
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
Hearing Loss, Sensorineural
CT and MRI for Pre-Operative Cochlear Imaging
This study investigates the role of the preoperative computed tomography (CT) and magnetic resonance imaging (MRI) before cochlear implants and their role in selecting suitable patients for surgery.
- Trial name
- NCT04131439
- Testing
- Computed Tomography and Magnetic resonance imaging
- Where
- Egypt
- Volunteers
- 50 people
- Sponsor
- Assiut University