Clinical trials: Cochlear Implants, open to volunteers
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
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
Hearing Loss, Cochlear
Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)
The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea.
- Trial name
- NCT03101917
- Testing
- The Microtable® Stereotactic System
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Medical University of South Carolina
Hearing Loss, Sensorineural, Hearing Loss
BEARS Training Package to Maximise Hearing Abilities in Older Children and Teenagers With Bilateral Cochlear Implants
The goal of the BEARS clinical trial is to determine whether using the directional listening training delivered via the BEARS training package for 3-months alongside usual care compared to only receiving usual care improves…
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Deafness, Hearing Impaired Children and Adolescents
- Trial name
- BEARS (NCT05808543)
- Testing
- Both EARS training package (BEARS), Usual Care
- Where
- 13 sites in United Kingdom
- Volunteers
- 272 people
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
Unilateral Hearing Loss, Asymmetric Hearing Loss
Evaluation of Cochlear Implantation in Unilateral or Asymmetric Hearing Loss in Children.
Today, unilateral hearing loss must be assessed and managed just as bilateral hearing loss is. It is recommended to consider the auditory difficulties caused by the loss of stereophonic hearing and to offer auditory…
- Trial name
- AsymIC-Ped (NCT06930170)
- Testing
- Cochlear implantation, CROS or BiCROS device fitting, French simplified matrix test (FraSimat)
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cochlear Implant Users
Cochlear Implants and Listening Effort: the Interaction of Cognitive and Sensory Constraints
This study examines how cochlear implant users understand and comprehend speech in realistic communication situations. Through six experiments measuring listening effort via pupillometry and discourse comprehension, we will…
- Trial name
- NCT07279441
- Testing
- Experiment 1: Syntactic and Semantic Context, Experiment 2: False Hearing and Context Overuse, Experiment 3: Two-Sentence Problem
- Where
- 2 sites in United States
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Cochlear Implants, Spatial Orientation
CI Spatial Orientation Study
The goal of this clinical trial is to learn if cochlear implant activation affects spatial orientation in cochlear implant users.
- Trial name
- CISPACE (NCT07510659)
- Testing
- Cochlear Implant
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Cochlear Implant Listeners
Pediatric Cochlear Implant Remote Programming and Assessment
This is a prospective, interventional study to evaluate efficacy and end user satisfaction of remote cochlear implant programming in the pediatric population.
- Trial name
- NCT07035873
- Testing
- Remote Programming, Remote Speech Perception
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Nationwide Children's Hospital
Hearing Loss, Cochlear Implantation
Same-Day Cochlear Implant Activation (SDA-CI)
This randomized controlled study investigates whether activating a cochlear implant on the day of surgery (same-day activation) leads to faster stabilization of cochlear implant programming compared with the current standard…
- Trial name
- SDA-CI (NCT07681830)
- Testing
- Same-Day Cochlear Implant Activation, Standard Day-14 Cochlear Implant Activation
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- University of Aarhus
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 Implants
Pitch Perception and Memory: Deficits and Training
Pitch perception and memory are central in auditory cognition, in particular for sound source segregation and recognition, speech prosody and music processing.
- Trial name
- Pitch_Train (NCT03707691)
- Testing
- Listening tests. Pitch training protocol, visuo-spatial training protocol, EEG/MEG/MRI recordings.
- Where
- France
- Volunteers
- 960 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Cochlear Implant, Outcomes
Anatomy-based Fitting in Cochear Implant Users
In this study, the performance with the CI is investigated over time in three groups of freshly implanted CI users. Both the standard frequency-band distribution and anatomy-based fitting will be used to compare outcomes.
- Conditions
- Cochlear Implant, Outcomes, Quality of Life
- Trial name
- NCT05360212
- Testing
- Anatomy-based fitting (ABF), Standard Fitting, Standard fitting+ ABF
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario la Paz
Hearing Loss, Hearing Implants
A Study to Evaluate Clinical Benefit, Performance and Safety of Cochlear Implants in Adults
The aim of this clinical investigation is to demonstrate the performance, clinical benefit and safety of commercial cochlear implant systems.
- Trial name
- ORBIT-MU (NCT07338864)
- Testing
- Cochlear Nucleus Nexa Cochlear implant (CI1032), Cochlear Nucleus Nexa Cochlear implant (CI1022), Cochlear Nucleus Nexa Cochlear implant (CI1012)
- Where
- Germany
- Volunteers
- 66 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss
Immunity After Cochlear Implantation and Perilymph Molecular Profiles in Sensorineural Hearing Loss
Many patients receiving cochlear implant (CI) have some residual hearing prior to implantation surgery. However, approximately one third of them will lose it in next 6 months after cochlear implantation.
- Trial name
- PERILOTO (NCT05670158)
- Testing
- Blood sampling, Perilymph sampling
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Montpellier
Fitting Methods by EAS Patients
Optimization and Validation of Electric Acoustic Stimulation (EAS) Mapping as a Function of Residual Hearing After CI-Implantation
The aim of this clinical study is to investigate how the fitting of an EAS (electrical acoustic stimulation) based on electrocochleography (ECochG) thresholds compares to fitting based on pure tone audiogram thresholds in terms…
- Trial name
- NCT07476079
- Testing
- The objective fitting method of the EAS based on the thresholds of electrocochleography is the intervention of our study., The subjective adjustment of an EAS based on thresholds from the pure tone audiogram.
- Volunteers
- 12 people
- Sponsor
- Luzerner Kantonsspital
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 Loss in Children With Unilateral or Bilateral Cochlear Implants
Feasibility and Reliability of Integrating Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement in a Pediatric Cochlear Implant Programming Center
In children aged 0 to 7 years, behavioral evaluation during cochlear implant programming is often difficult or unreliable. Objective, reproducible, and rapid markers are therefore essential.
- Trial name
- eSRT2 (NCT07417956)
- Testing
- Electrically Evoked Stapedius Reflex Threshold (eSRT) Measurement
- Where
- France
- Volunteers
- 48 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Profound Congenital Deafness, Cochlear Implantation
Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions.
- Trial name
- ACLEIC (NCT05917496)
- Testing
- LENA tool: Language ENvironment Analysis, Return of the analysis of the data of LENA
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Deafness
Restauration of the Auditory and Cognitive Functions in Cochlear Implanted Deaf Children in fNIRS
The principal aim of this study is to evaluate the cortical developement of perceptual skills and executive functions over time, in children with cochlear implants aged 10-24 months and 3-7 years compared with normally hearing…
- Trial name
- HearCog (NCT04495660)
- Testing
- Near InfraRed Spectroscopy (fNIRS), Passive perceptual stimulation, Task A not B
- Where
- France
- Volunteers
- 80 people
- Sponsor
- University Hospital, Toulouse
Sensorineural Hearing Loss, Cochlear Implantation
Perceptual Adaptation Following Cochlear Implantation (Aim 3a)
The goal of this study is to study the adaptation process in newly implanted Single-Sided Deaf Cochlear Implant (SSD-CI) users. Subjects will use four frequency maps for the first month after CI activation.
- Conditions
- Sensorineural Hearing Loss, Cochlear Implantation, Perceptual Adaptation
- Trial name
- NCT07039435
- Testing
- Alternative Frequency Mapping
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- NYU Langone Health