Clinical trials: Deafness With a Cochlear Implant
Hearing Loss
Speech Performance and Clinic Efficiency With Remote Care Compared With Standard of Care in Adults With a Cochlear Implant in the First 12 Months Post-activation
The aim of the study is to assess the real-world effectiveness of managing participants within the first year post-activation (between 3 and 12 months) using Cochlear's Remote Care (Remote Check and Remote Assist), as compared…
- Trial name
- INSPIRE (NCT05552118)
- Testing
- Cochlear™ Remote care, Standard of care, Compatible Implant Series and Compatible Sound Processors
- Where
- 11 sites in Australia, Belgium and 3 more
- Volunteers
- 148 people
- Sponsor
- Cochlear
Hearing Loss
Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.
- Trial name
- IROS (NCT02004353)
- Testing
- Cochlear® Hearing Implants
- Where
- 77 sites in Argentina, Austria and 14 more
- Volunteers
- 1,518 people
- Sponsor
- Cochlear
Hearing Loss
Combined Acoustic and Electric Hearing (CI/HA) in Adult Bimodal Users Using a HA With a Bimodal Fitting Formula
Introduction: Bilateral-bimodal users may benefit from bilateral-binaural and a bimodal effect . The two modes of stimulation complement each other and may overcome the limitation of electric hearing alone.
- Trial name
- NCT03142100
- Testing
- cochlear implants and hearing aids
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bnai Zion Medical Center
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
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
Multi-center Study to Examine Changes to the Environment Surrounding the Electrodes in the Cochlea and to Capture the Most Challenging Listening Environments Experienced by Persons With a Cochlear Implant
This early feasibility study aims to collect pilot data on impedance measurements in real-world environments and to collect real-world and difficult listening situations and the factors impacting this, reflecting situations the…
- Trial name
- DICE (NCT06173687)
- Testing
- The impedance measurement task using the Mobile Research App (MRA)
- Where
- 4 sites in Australia, Belgium and 1 more
- Volunteers
- 51 people
- Sponsor
- Cochlear
Deafness
Ambulatory Telemonitoring of People With Hearing Loss and Having a Cochlear Implant COCHLESURV
The number of patients with cochlear implants increases every year, constituting an active queue increasingly important (60 new cases per year in Toulouse, active list in 2013: 380 adult patients).
- Trial name
- COCHLESURV (NCT02890576)
- Testing
- telemedicine
- Sponsor
- University Hospital, Toulouse
Deafness
Development of a Deaf Child With a Cochlear Implant.
Cochlear implantation enables profoundly deaf children to acquire speech and develop their understanding of spoken language. However, there are significant interindividual differences in the results obtained with the implant.
- Trial name
- DECCODES (NCT02539901)
- Testing
- Evaluation of the detection of non-linguistic sounds, Free hearing test categorization, Early Social Communication Scale (ECSP)
- Where
- France
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- University Hospital, Toulouse
Hearing Loss, Ear Diseases
Clinical Evaluation of a Cochlear Implant Sound Processor
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer).
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otorhinolaryngologic Diseases
- Trial name
- NCT04237207
- Testing
- Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software, 301-M062 sound processor & software
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- Advanced Bionics
Deaf Children, Cochlear Implant
Assessment of the Development of Social Cognition in a Deaf Child With a Cochlear Implant : A Study Using a Standardized Questionnaire
This study investigates the adaptability of a questionnaire assessing social cognition in children with cochlear implants aged 3 to 6 years, implanted before the age of 15 months.
- Trial name
- 1OL1 (NCT06914531)
- Testing
- Questionnaire comprehension test
- Where
- France
- Volunteers
- 6 people
- Sponsor
- University Hospital, Toulouse
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
Deafness With a Cochlear Implant
Stimulating the Cochlear Apex Without Longer Electrodes
The most common cochlear implant intervention provides an electrode array that stimulates less than half of the length of the cochlea, leaving the regions which represent lower frequencies in the normally functioning ear…
- Trial name
- NCT06901674
- Testing
- Modified surgical approach, Cochlear Nucleus CI632 cochlear implant
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- NYU Langone Health
Hearing Loss, Bilateral Sensorineural
A Pivotal Study to Evaluate the Clinical Benefit, Performance and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
This pivotal study examines the clinical efficacy and safety of an investigational totally implantable cochlear implant (TICI) system.
- Trial name
- ELEVATE (NCT07287124)
- Testing
- Cochlear implant
- Where
- 11 sites in United States
- Volunteers
- 56 people
- Sponsor
- Cochlear
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
Hearing Loss, Sensorineural
Evaluation of Speech-in-noise Performance in Cochlear Implant Recipients With a CROS Device on the Contralateral Ear
Speech understanding in noise remains the greatest challenge for people using cochlear implants, particularly when the speech of interest comes from the side of the head opposite to the implant.
- Trial name
- NCT03867396
- Testing
- CROS, Hearing Aid, Cochlear Implant Alone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Colorado, Denver
Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Designing a Trial of Bilateral Cochlear Implantation in Adults
In the UK, cochlear implantation is the standard treatment for adults with 'severe-to-profound' deafness. This level of deafness means that without a cochlear implant they have difficulty understanding what people are saying even…
- Trial name
- FOUNDATION (NCT03287700)
- Testing
- No intervention
- Where
- United Kingdom
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Nottingham University Hospitals NHS Trust
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
Hearing Loss, Sensorineural, Cochlear Implantation
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
- Trial name
- AIMBOT (NCT06664710)
- Testing
- iotaSOFT Insertion System with AIM, iotaSOFT Insertion System with AIM Control
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- iotaMotion, Inc.
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
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