Clinical trials: Bilateral Cochlear Implants
Sensorineural Hearing Loss, Bilateral
Study of Auditory Performance on Prosodic Tests in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate how the FineHearing strategy of the MED-EL cochlear implant can extract prosody based solely on the frequency of the voice fundamental (F0) in speech Secondary objectives: Evaluate the time evolution…
- Trial name
- NCT03694704
- Testing
- FineHearing strategy
- Where
- France
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.
- Trial name
- NCT04777565
- Testing
- Robotic surgery
- Where
- France
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
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
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
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, Bilateral
A Study of Objective Fitting for Focused Multipolar Stimulation
The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.
- Trial name
- OFIT (NCT05763342)
- Testing
- The Phoenix Research System
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
Main objective: Investigate on new cochlear implanted patients whether the FineHearing strategy of the MED-EL cochlear implant gives better results on musical perception if the depth of stimulation (stimulation or not of the…
- Trial name
- NCT04591093
- Testing
- FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated
- Where
- France
- Volunteers
- 32 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
Hearing Loss, Sensorineural
Evaluation of the Efficacy and Safety of the Sullivan Cochlear Implant.
The study will be conducted as a prospective, single center, repeat measure, single-arm, open label clinical study
- Trial name
- NCT07018882
- Testing
- Sullivan
- Volunteers
- 25 people
- Sponsor
- Todoc
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
A Monocentric Study Evaluating Pupillometry as an Objective Measurement for CI Fittings
This trial is a monocentric, prospective and controlled study of the pupil response to detect hearing threshold and comfortable loudness of normal-hearing (NH) and CI-subjects.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Cochlear Hearing Loss, Hearing Loss, Cochlear
- Trial name
- PupillOM (NCT05586555)
- Testing
- Pupillometry (Eve-tracking measurements)
- Where
- France
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Oticon Medical
Tinnitus, Subjective, Tinnitus, Bilateral
Tinnitus Patient Preferences Survey
The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation).
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Tinnitus, Noise Induced, Tinnitus, Hearing Loss, Cochlear Implant Users
- Trial name
- NCT06782308
- Testing
- Survey using a questionnaire.
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Nicolas Gninenko
Sensorineural Hearing Loss, Bilateral
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Fitting With or Without Fine Structure Coding
Brief Summary: Main objective: Comparison of a tonotopy based fitting strategy (TFS) with fine structure coding to a tonotopy based fitting strategy without fine structure coding (TnoFS) for speech perception in noise.
- Trial name
- NCT05754918
- Testing
- TnoFs then TFS (Cochlear implant), TFS then TnoFS (Cochlear implant)
- Where
- France
- Volunteers
- 21 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral, Cochlear Implant
Clinical Investigation of New CI Delivery Models in an Adult Nucleus CI Population
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
- Trial name
- NCT03304106
- Testing
- Commercially available cochlear implant and AI system
- Where
- 9 sites in United States
- Volunteers
- 102 people
- Sponsor
- Cochlear
Cochlear Implant, Hearing Loss, Bilateral or Unilateral
The Performance of Different Sound Paths in Adult NeuroZti CI-users
The goal of this clinical trial is to compare speech perception and user satisfaction between two sound paths, Nuc8 (Cochlear Nucleus sound path) and Neu2 (Neuro 2 sound path), in adult users of the NeuroZti cochlear implant.
- Trial name
- Percepolis (NCT07033130)
- Testing
- OMRP R2 + Percepolis Accessory Software, Nuc8 Sound Path, Neu2 Sound Path
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Cochlear
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
Sensorineural Hearing Loss, Bilateral
CI532 - Early Experience Study
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
- Trial name
- NCT02755935
- Testing
- Cochlear Nucleus CI532
- Where
- 6 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cochlear
Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural
A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss
This clinical study will test a new investigational totally implanted cochlear implant system (TICI G2). The cochlear implant has an implantable microphone under the skin to detect speech and sound from the environment allowing…
- Conditions
- Hearing Loss, Bilateral or Unilateral, Hearing Loss, Sensorineural, Hearing Loss, Cochlear
- Trial name
- ENHANCE (NCT06642935)
- Testing
- Totally implantable cochlear Implant
- Where
- Australia
- Volunteers
- 18 people
- Sponsor
- Cochlear
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
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
An Actual Use, Open-label Study Assessing Usability of Remote Assist to Program Cochlear Implant Recipients
Clinical management of cochlear implant (CI) recipients involve programming, counselling, performance evaluation and habilitation.
- Trial name
- RAL (NCT04987021)
- Testing
- Cochlear Implant (CI)-CI500 series, CI600 series or Freedom series cochlear implants
- Where
- Australia
- Volunteers
- 15 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.