Clinical trials: Cochlear Implants
Adult Cochlear Implant Recipients
Acceptance and Performance of CP1110 Sound Processor With Experienced Adult Cochlear Implant Recipients.
The clinical study aims to investigate acceptance, actual-use usability and speech performance with a new behind-the-ear sound processor (model number: CP1110) system, compared with the commercially available Nucleus 7 Sound…
- Trial name
- PINNA (NCT05080283)
- Testing
- CP1110 Sound Processor System with automated ForwardFocus On (SCAN 2 FF), Nucleus 7 Sound Processor (model: CP1000) system, CP1110 Sound Processor System with ForwardFocus Off (SCAN 2)
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cochlear
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
Deafness
Localization and Mismatch Negativity
This descriptive and observational research project aims to characterize MMN as a neuronal marker of localization deficit in single-sided deafened subjects and subjects with bilateral profound deafness treated by a cochlear…
- Trial name
- MMNLocA (NCT03632551)
- Testing
- Specific binaural hearing evaluations
- Where
- France
- Volunteers
- 91 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Unilateral Deafness
Evaluation of Rehabilitation Results in the Single-sided Deafness With Cochlear Implantation
Single-sided deafness (SSD) refers to severe to profound sensorineural hearing loss on one side (average pure-tone hearing threshold≥70 dB HL at 0.5, 1, 2, and 4kHz) while the opposite side maintains normal hearing or mild…
- Trial name
- NCT05435612
- Testing
- cochlear implant
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Chinese PLA General Hospital
Cochlear Implant
Tissue Growth Characterization for Cochlear Implant Users
It is known from post-mortem histological studies that a significant portion of individuals who undergo cochlear implantation (CI) have scar tissue form around the implanted electrode array over time.
- Trial name
- NCT04320251
- Testing
- cochlear implant revision surgery
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Vanderbilt University Medical Center
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 Implant, Sensorineural Hearing Loss
Anatomy-Based Fitting in Bimodal Cochlear Implant Users
The purpose of the study is to investigate the effect of an anatomy-based frequency distribution in comparison to a default frequency distribution in bimodal CI patients, i.e.
- Conditions
- Cochlear Implant, Sensorineural Hearing Loss, Hearing Aid
- Trial name
- NCT07691853
- Testing
- Anatomy-based fitting, Default fitting
- Where
- 2 sites in Belgium
- Volunteers
- 25 people
- Sponsor
- Universitair Ziekenhuis Brussel
Anesthesia
Role of LIDOCAINE IN Pediatric Cochlear Implant Surgery
The stapedius reflex protects the ear from the loud noise. The measurement of the intraoperative electrically evoked stapedial reflex threshold (ESRT) during pediatric cochlear implants (CIs) is used to confirm that the implant…
- Trial name
- NCT04194294
- Testing
- Lidocaine, Na CL 0.9%
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Wahba bakhet
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
Dementia, Hearing Loss
Evaluation of the Impact of Cochlear Implants on Cognition in Older Adults
The subjects will be age 65 years and older, with no upper limit of age range with hearing loss that are candidates for standard-of-care cochlear implant.
- Conditions
- Dementia, Hearing Loss, Presbycusis
- Trial name
- NCT02729402
- Testing
- Cognitive Testing
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Utah
Hearing Loss, Hearing Loss, Sensorineural
Optimizing Bilateral and Single-sided-deafness Cochlear Implants for Functioning in Complex Auditory Environments
Cochlear implants (CIs) are devices that partially restore hearing for people with severe to profound hearing loss. This research focuses on CI users who use bilaterally implanted devices (two CIs, one on each side) and also…
- Conditions
- Hearing Loss, Hearing Loss, Sensorineural, Cochlear Hearing Loss
- Trial name
- NCT06305039
- Testing
- Diagnostic tests of cochlear implant or acoustic hearing function, Targeted aural rehabilitation of the poorer performing ear
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Maryland, College Park
PROM, Cochlear Hearing Loss
A Study Evaluating the French Version of the CIQoL-35 Quality of Life Questionnaire in Adult Cochlear Implant Use.
The Cochlear Implant - Quality of Life (CIQoL) PROM is a quality-of-life assessment questionnaire for adults with cochlear implants.
- Conditions
- PROM, Cochlear Hearing Loss, Hearing Loss, Quality of Life
- Trial name
- CIQoL (NCT05709431)
- Testing
- Questionnaire CIQoL-35
- Where
- France
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
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
Deafness; Perception, Bilateral
Musical Training in Cochlear Implant Users
With this protocol we want to investigate the degree to which the use of Meludia training (the online self-paced music training application) can improve music perception, music enjoyment, and speech understanding in pediatric and…
- Trial name
- NCT06540677
- Testing
- Musical training
- Volunteers
- 80 people
- Sponsor
- Hospital Universitario La Paz
Deafness
Novel Coding Strategies for Children With Cochlear Implants
The purpose of this study is to understand performance with a cochlear implant. The long-term goals of this research are to improve sound perception with cochlear implants and to better understand the functioning of the auditory…
- Trial name
- NCT05203302
- Testing
- Single-Electrode Pulse Train, Modulation Detection Threshold (MDT) and Gap Detection Tasks, Sound coding strategy.
- Where
- United States
- Volunteers
- 190 people, healthy volunteers welcome
- Sponsor
- NYU Langone Health
Sensori-Neural Deafness
Pilot Clinical Study Using Pre-operative Simulation for Patients Undergoing Cochlear Implant
36 patients will be enrolled in a pilot trial. Eligible patients (receiving CI at OSU) that consent to participate into the study will be enrolled.
- Trial name
- NCT04588870
- Testing
- Pre operative computer based cochlear implant surgical simulation
- Sponsor
- Nationwide Children's Hospital
Cochlear Hearing Loss
Safety and Performance of HiRes Ultra/Ultra 3D Cl Mid-Scala Electrodes in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiRes Ultra Cl HiFocus MS Electrode and HiRes Ultra 3D Cl HiFocus MS Electrode (Ultra X) under normal conditions of use as it is approved for this…
- Trial name
- NCT04610112
- Testing
- Cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 30 people
- Sponsor
- Advanced Bionics AG
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, Cochlear Implants
Place-based Cochlear Implant Mapping
The current standard of care approach for programming cochlear implants uses a generalized pitch-map for all patients. This approach fails to account for individualized inner ear anatomy.
- Trial name
- NCT05558514
- Testing
- Place-based cochlear implant mapping, Default cochlear implant mapping
- Where
- Canada
- Volunteers
- 24 people
- Sponsor
- Western University, Canada
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