Clinical trials: Bilateral Cochlear Implants
Sensorineural Hearing Loss, Bilateral
Study of Quality Perception on Music in New Cochlear Implanted Subjects Using or Not a Fine Structure Strategy
Main objective: Show the superiority of Fine Structure (FS4) strategy compared to Continuous Interleaved Sampling (HDCIS) strategy on the qualitative preference for the listening of musical pieces.
- Trial name
- NCT03993899
- Testing
- FineHearing strategy or HDCIS strategy
- Where
- France
- Volunteers
- 19 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Bilateral Sensorineural Hearing Loss
Evaluation of Revised Indicatons (ERID) for Cochlear Implant Candidacy for the Adult CMS Population
Purpose: The purpose of this study is 1) to evaluate the safety and efficacy of currently available multichannel cochlear implant systems for newly implanted adults with an indication based on open-set sentence recognition that…
- Trial name
- NCT02075229
- Testing
- Cochlear implant
- Where
- 19 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- American Cochlear Implant Alliance
Sensorineural Hearing Loss, Bilateral, Bilateral Hearing Loss
Comparison in New Cochlear Implanted Subjects of a Tonotopy-based Bimodal Fitting and a Conventional Fitting
Main objective: For a bimodal fitting (hearing aid (HA) + cochlear implant (CI)): Comparison of a tonotopy based fitting strategy (TFS4) to a default fitting strategy (FS4) for the speech recognition in noise.
- Trial name
- NCT05955469
- Testing
- FS4 then TFS4 (cochlear implant), TFS4 then FS4 (cochlear implant)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Study of Sound and Speech Perception in New Cochlear Implanted Subjects Using or Not an Anatomy-based Fitting
Main objective: Compare the recognition of environmental sounds with an anatomy-based fitting and with a default fitting adult patients newly implanted with a MED-EL cochlear implant.
- Trial name
- NCT05230498
- Testing
- anatomy-based fitting then default fitting, default fitting then anatomy-based fitting
- Where
- France
- Volunteers
- 17 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Bilateral
Study of Music and Speech Perception in New Cochlear Implanted Subjects Using or Not a Tonotopy Based Fitting
Main objective: Show the superiority of tonotopy based fitting strategy compared to default fitting strategy on the perception speech in noise.
- Trial name
- NCT04922619
- Testing
- tonotopy based fitting then default fitting, default fitting then tonotopy based fitting
- Where
- France
- Volunteers
- 26 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Characterisation of Low Frequency Hearing and Vestibular Function in Patients Undergoing Cochlear Implantation
The study will follow a cohort of CI-candidates becoming CI-user, till two years postoperative. A through-out assessment of both their audiological and vestibular status will be carried out at multiple fixed timepoints over 2…
- Trial name
- NCT06021132
- Testing
- cochlear implant
- Where
- Denmark
- Volunteers
- 39 people
- Sponsor
- Aalborg University Hospital
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
Sensorineural Hearing Loss, Bilateral
Comparison of Speech Understanding Between Tonotopy-based Fitting and Setting Based on Evolutionary Algorithms
Main objective: Compare speech recognition in noise with tonotopic setting (FS4T) and with tonotopic fitting modified by evolutionary algorithm (EAFS4T) in adult patients implanted for 6 months or more with a MED-EL cochlear…
- Trial name
- NCT06737185
- Testing
- EAFS4T: modification with evolutionary algorithm of tonotopic-based fitting
- Where
- France
- Volunteers
- 22 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensori-Neural Deafness, Sensorineural Hearing Loss
Pivotal Clinical Trial Evaluating the Safety and Efficacy of the Fully Implanted Acclaim Cochlear Implant
The goal of this clinical trial is to learn if the Acclaim CI works to treat severe to profound sensorineural hearing loss in adults. It was also learn about the safety of the Acclaim CI implant.
- Conditions
- Sensori-Neural Deafness, Sensorineural Hearing Loss, Sensorineural Hearing Loss (Disorder), Sensorineural Hearing Loss, Bilateral
- Trial name
- NCT06699797
- Testing
- Acclaim Cochlear Implant
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Envoy Medical Corporation
Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients
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
- Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis
- Trial name
- NCT02102256
- Testing
- Auditory Brainstem Implant
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Laurie Eisenberg
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
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This clinical study examines the performance of an investigational totally implantable cochlear implant (TICI) system. The system includes an implantable microphone under the skin to detect speech and sound from the environment…
- Trial name
- ENTERPRISE (NCT07139327)
- Testing
- Cochlear Implant
- Where
- 8 sites in Australia, France
- Volunteers
- 36 people
- Sponsor
- Cochlear
Deafness, Bilateral
Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention
The purpose of this research study is to develop and evaluate a parent training program, which aims to improve language. The study is being conducted to see if teaching parents positive parenting techniques and behavior…
- Trial name
- PEARLS (NCT03260062)
- Testing
- Parent-Child Early Approaches to Raising Language Skills, Standard Care Speech therapy
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Miami
Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe
Post Approval Study to Assure the ContInued saFety and effectIveness of Neuro Cochlear Implant System in Adult Users
On June 23, 2021, the Oticon Medical Neuro Cochlear Implant System (NCIS) was granted premarket approval (PMA) in the US to treat individuals 18 years or older, with bilateral severe-to-profound sensorineural hearing loss, who…
- Conditions
- Sensorineural Hearing Loss, Bilateral, Sensorineural Hearing Loss, Severe, Sensorineural Hearing Loss, Profound
- Trial name
- PACIFIC (NCT05154188)
- Testing
- Neuro Cochlear Implant system
- Volunteers
- 60 people
- Sponsor
- Oticon Medical
Sensorineural Hearing Loss, Bilateral Hearing Loss
Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants
This research study is evaluating two different methods of cochlear implant (CI) insertion - robotic-assisted insertion and manual insertion - to better understand how they affect hearing outcomes.
- Conditions
- Sensorineural Hearing Loss, Bilateral Hearing Loss, Cochlear Implantation, Hearing Disorders
- Trial name
- NCT07081542
- Testing
- IotaSoft Robotic Insertion System, Manual Cochlear Implant Insertion
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- AdventHealth
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
Ear Diseases, Hearing Loss, Bilateral
Lumity CI Study - Clinical Evaluation of Next Generation Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 18 bilateral adult users implanted with a HiResolution Bionic Ear System (HiRes 90KTM, HiRes 90K TM Advantage, HiResTM Ultra, HiResTM Ultra 3D and CII…
- Conditions
- Ear Diseases, Hearing Loss, Bilateral, Otorhinolaryngologic Diseases
- Trial name
- NCT06858826
- Testing
- Control cochlear implant sound processor, Next Generation Sound Processor
- Volunteers
- 20 people
- Sponsor
- Advanced Bionics
Profound Bilateral Hearing Loss
Clinical Evaluation of Robot-assisted Cochlear Implant Insertion in Adults Using RobOtol® Compared to Manual Insertion
The purpose of this study is to evaluate, via a randomised controlled design, the efficacy of the robotic insertion of cochlear implant, versus manual insertion. Robotic insertion will be performed using Robotol.
- Trial name
- ROBIICCA (NCT05696171)
- Testing
- Cochlear implant manual insertion, Cochlear implant robotized insertion
- Where
- 14 sites in France
- Volunteers
- 550 people
- Sponsor
- Nantes University Hospital
Bilateral Cochlear Implants, Hearing Loss, Bilateral
Spatial Cues, Task Demands, and Auditory Selective Attention
Understanding speech in restaurants and other noisy environments is the most common complaint from the more than 60 million Americans with hearing impairment.
- Conditions
- Bilateral Cochlear Implants, Hearing Loss, Bilateral, Healthy
- Trial name
- NCT07765186
- Testing
- Existing bilateral cochlear implants, Normal Hearing Control
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Bilateral Sensorineural Hearing Loss
Effect of Donepezil on Speech Recognition in Cochlear Implant Users
Hearing loss is a major cause of disability that affects over 48 million Americans. There are currently no medications used to treat sensorineural hearing loss.
- Trial name
- NCT05438264
- Testing
- Donepezil
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Vanderbilt University Medical Center