Clinical trials: Cochlear Implant
Cochlear Implant Users
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
Cochlear implants help individuals with hearing loss by delivering electrical signals directly to the auditory nerve, bypassing damaged parts of the ear.
- Trial name
- M11S3 (NCT07213505)
- Testing
- Testing new front-end features
- Where
- 2 sites in Austria
- Volunteers
- 40 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Hearing Loss, Unilateral, Hearing Loss, Profound
Iowa Cochlear Implant Clinical Research Center Study of SSD Using Med-El Cochlear Implants
The purpose of this study is to understand the speech perception in noise and in quiet and localization benefits in a laboratory setting in listeners that receive a cochlear implant in an ear with severe to profound hearing loss…
- Trial name
- NCT03929809
- Testing
- Cochlear Implant
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Iowa
Hearing Loss
Bilateral Cochlear Implant Benefit in Young Children
The primary purpose of this study is to track patient outcomes for bilateral cochlear implant recipients in a cohort of 60 children, ages 12 to 36 months at time of surgery, who receive two implants in the same operation or in…
- Trial name
- NCT00424307
- Testing
- HiResolution Bionic Ear System
- Where
- 14 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Advanced Bionics
Deafness, Bilateral
Study of the Role of Top-down Processes in Neuronal Reorganization and Recovery From Sensory Loss: an Exploratory Behavioral and Electroencephalographic Study in Cochlear-supported Deaf Patients
This study posits that central top-down processes (attention, inhibition), marked by alpha oscillations in EEG, play a key role.
- Trial name
- REASCENT (NCT07500909)
- Testing
- neurophysiological assessment, Cognitive, behavioral and quality of life assessment
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Cochlear Implants
Channel Interaction in Cochlear Implant and Speech Understanding in Noise
The goal of this study is to take into account channel interaction in the cochlear implant (CI) fitting process. Designing a fast and accurate method of measurement would help to customize the fitting procedures to patients'…
- Trial name
- 2IPIC (NCT03877211)
- Testing
- speech audiometry in noise, Psychophysical tuning curves in forward masking, Electrically-evoked Auditory Brainstem Response (EABR)
- Where
- France
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Hospices Civils de Lyon
Hearing Loss
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
- Trial name
- NCT01072409
- Testing
- Nucleus 5 Cochlear implant, Cochlear implantation
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Cochlear
Cochlear Implants, Sensorineural Hearing Loss, Bilateral
Audiological and Quality of Life Outcomes of Anatomy Based Fitting in Patients Implanted by Robot Assisted Cochlear Implant Surgery (RACIS)
Severe to profound hearing loss affects 0,8% of the global population. For these people, a conventional hearing aid often does not provide sufficient benefit. However, these people can benefit from a cochlear implant (CI).
- Trial name
- RACIS ABF (NCT05369598)
- Testing
- Post-operative ABF followed by fitting according to clinical standard, Fitting according to clinical standard followed by post-operative ABF
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Universitair Ziekenhuis Brussel
Hearing Loss
Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users
The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral cochlear implant hearing in comparison to unilateral cochlear implant hearing in the perception of speech intonation.
- Trial name
- NCT02323932
- Testing
- Perception of correct intonation identification
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Bnai Zion Medical Center
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
Sensorineural Hearing Loss (Disorder)
Single-sided Deafness and Cochlear Implants
As the left and right hemisphere are specialized for different auditory tasks, the proposed study aims at demonstrating different consequences of right or left-sided deafness for the affected individual.
- Trial name
- NCT01749592
- Testing
- cochlear implant
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- University of Zurich
Sensorineural Hearing Loss
The Performance of a Robot-assisted Minimally Invasive Direct Cochlear Access for Cochlear Implantation
The cochlear implant is a neural prosthesis and has been the gold standard treatment for severe to profound sensorineural hearing loss over several decades.
- Trial name
- NCT04610450
- Testing
- HEARO, OTOPLAN
- Where
- Switzerland
- Volunteers
- 3 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural
Performance and Hearing-related Outcomes in Adults Implanted With the CI622D Dexamethasone-eluting Cochlear Implant Compared to Those Implanted With a Standard Cochlear Implant (CI622)
This clinical study will test a newly developed cochlear implant known as CI622D. This experimental cochlear implant has been designed to slowly release a drug called dexamethasone.
- Conditions
- Hearing Loss, Bilateral Sensorineural, Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Cochlear
- Trial name
- DETECT (NCT06424262)
- Testing
- CI622D, CI622
- Where
- 11 sites in Australia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Cochlear
Hearing Loss, Unilateral, Deafness, Unilateral
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for…
- Trial name
- PAS-SSD (NCT05318417)
- Testing
- The Cochlear™ Nucleus® Cochlear Implant (CI) System
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cochlear
Sensorineural Hearing Loss, Bilateral
Speech Perception of a Tonotopy-based Fitting for Cochlear Implant Recipients for 6 Months With Conventional Setting
Main objective: Compare speech recognition in noise with tonotopic fitting (FS4T) and with conventional non-tonotopic fitting (FS4noT) in adult patients implanted for 6 months with a MED-EL cochlear implant with FS4noT strategy.
- Trial name
- NCT06723262
- Testing
- Tonotopic cochlear implant fitting FS4T
- Where
- France
- Volunteers
- 25 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Severe Unilateral Sensorineural Hearing Loss
Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss
Do adults and children over 7 years of age with unilateral or assymetric hearing loss benefit from cochlear implantation on the worst hearing side.
- Trial name
- CI and SSD (NCT02105441)
- Testing
- Cochlear implant
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Mayo Clinic
Retrocochlear Pathology, Auditory Processing Disorder, Central
Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study.
The investigators assume that cochlear implants in this indication are not only effective but also cost-effective. The investigators' experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be…
- Conditions
- Retrocochlear Pathology, Auditory Processing Disorder, Central, Major Cochlear Ossification or Malformation
- Trial name
- CISSD (NCT02204618)
- Testing
- cochlear implantation, 6 months initial abstention
- Where
- France
- Volunteers
- 160 people
- Sponsor
- University Hospital, Toulouse
Profound Deafness
Optimization of Cochlear Implant Fitting in Patients With Functional Contralateral Hearing Using an Evolutionary Algorithm.
360 million people worldwide suffer from disabling hearing loss. The prevalence of hearing impairment, all stages combined, in the French population is 7% (4 million people), of which 9% have severe impairment and 3% have…
- Trial name
- Algo Fréq (NCT04888143)
- Testing
- questionnaires, Evolutionary algorithm
- Where
- France
- Volunteers
- 18 people
- Sponsor
- Centre Hospitalier Universitaire Dijon
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
Deafness, Bilateral, Deafness Neurosensory
Auditory Diagnostics and Error-based Treatment
The main objective of this study is to assess the effectiveness of an integrated program of fitting and training interventions aimed at reducing unexpected variability and addressing the specific error patterns of each recipient.
- Conditions
- Deafness, Bilateral, Deafness Neurosensory, Deafness Permanent
- Trial name
- AuDiET (NCT05307952)
- Testing
- Tone Audiometry, Spectrotemporal Assessment, Phoneme and Speech Perception
- Where
- Netherlands
- Volunteers
- 25 people
- Sponsor
- Radboud University Medical Center
Anesthesia
Role of Magnesium in Pediatric Cochlear Implant
To determine the efficiency of addition of magnesium sulfate to total intravenous anesthesia (TIVA) in optimizing the surgical field during pediatric cochlear implant surgery.
- Trial name
- NCT03722940
- Testing
- Magnesium sulphate, Na CL 0.9%
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Wahba bakhet