Clinical trials: Cochlear, active
Cochlear Implantation, Robotics
Robotic-Assisted Versus Manual Electrode Array Insertion
Robotics-assisted electrode insertion overcomes many surgeon-related kinetic limitations such as insertion speed, tremor, drift, and lack of accurate force control.
- Trial name
- NCT06951594
- Testing
- Robotic
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Bruce J Gantz
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
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
Cochlear Hearing Loss
MeasurIng and Restoring Auditory Awareness for Cochlear Implant Listeners in noisE
The goal of this interventional study is to describe how people with cochlear implants perceive the perceive speech in noise and their sound environment on adults who are native French speakers with typical hearing or with…
- Trial name
- MIRACLE (NCT06420921)
- Testing
- Speech in noise comprehension test, Objective tests of perception of ambient sound cues in noise, Subjective tests of perception of ambient sound cues in noise
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Institut Pasteur
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
Hearing Loss
An Investigation to Validate Speech Perception Assessment for Adult Cochlear Recipients Using a Mobile Research App
The study is a feasibility, prospective, repeated-measures, multi-country, multi-centre, study of the Mobile Research App to measure and validate speech perception endpoints in adult cochlear implant recipients.
- Trial name
- VALDE-MU (NCT06098482)
- Testing
- Mobile Research App (MRA), SOC/validated delivery of the speech perception test material
- Where
- 4 sites in United States, Australia and 1 more
- Volunteers
- 46 people
- Sponsor
- Cochlear
Cochlear Implantation, Sensorineural Hearing Loss
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
MED-EL Cochlear Implants (CI) provide auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in…
- Trial name
- LORIS (NCT07697911)
- Testing
- Transfer of data of SONATA 2 cochlear implant recipients
- Where
- 2 sites in Spain
- Volunteers
- 200 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Profound Congenital Deafness, Cochlear Implantation
Analysis of Parental Support in Families Using the LENA After Early Cochlear Implantation
The language environment that influences the child's language development has been studied using different subjective tools, mainly audio and/or video recording and manual transcriptions.
- Trial name
- ACLEIC (NCT05917496)
- Testing
- LENA tool: Language ENvironment Analysis, Return of the analysis of the data of LENA
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Sensorineural Hearing Loss, Bilateral Hearing Loss
Long-term Follow-up of a Cochlear Implant With Dexamethasone Eluting Electrode Array
A long-term follow-up of Cochlear's cochlear implant electrode array which passively elutes dexamethasone for a defined period of time to help reduce inflammatory responses.
- Trial name
- CI-DEX-LTFU (NCT06936449)
- Testing
- CI632D, CI632
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Cochlear
Auditory Perception; Abnormal, Hearing Loss, Sensorineural
Listening Effort in Cochlear Implant Users
People with hearing loss experience extra effort when listening, which can lead to severe psychological barriers to communication and social participation.
- Conditions
- Auditory Perception; Abnormal, Hearing Loss, Sensorineural, Hearing Loss
- Trial name
- NCT06516575
- Testing
- sentence manipulations
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Cochlear Implant, Hearing Loss
CRESCENDO: ChildREn's muSiC ENhancement in Cochlear Implant Users
This exploratory, single-center, single-arm study investigates the impact of a 12-week Multimodal Acoustic Therapy (MAT) intervention followed by a 12-week follow-up period on both objective and subjective auditory perception in…
- Trial name
- NCT07297524
- Testing
- Mobile Auditory Rehabilitation
- Where
- South Korea
- Volunteers
- 25 people
- Sponsor
- Seoul National University Hospital
Profound Hearing Loss, Cochlear Implants
The Value Electrical Stapedial Reflex Thresholds (eSRTs) Cochlear Implant Mapping
One of the most significant challenges in cochlear implant programming, particularly for very young children and those with an associated pathologies, is the measurement of subjective comfort levels (= C-Subjective).
- Trial name
- eSRT (NCT06051006)
- Testing
- ESR and ECAP measurements, Device setting, Speech audiometry
- Where
- France
- Volunteers
- 30 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Hearing Loss, Sensorineural, Severe-to-profound Hearing Loss
Hearing and Structure Preservation Via ECochG
The goal of the study is to determine the benefit of using an ECochG-based corrective action guide during cochlear implant surgery compared to the traditional surgical approach without ECochG surveillance and guidance.
- Trial name
- PRESERVE (NCT06268340)
- Testing
- ECochG monitored CI surgery incl. corrective action guide, Routine CI surgery without ECochG monitoring
- Where
- 7 sites in Belgium, France and 5 more
- Volunteers
- 102 people
- Sponsor
- Advanced Bionics AG
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
Hearing Loss, Cochlear Implants
Encoding Temporal Fine Structure for Cochlear Implants
The goal of this study is to improve music and speech perception for cochlear implant users. Presently, most cochlear implants discard the temporal fine structure of sound, which is information that is widely believed to…
- Trial name
- TFS4CIs (NCT04708717)
- Testing
- Stimulation Rate, Electrode Location
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Southern California
Hearing Disorder
Evaluation of Cochlear (Promontory) Stimulation During Awake Ear Surgery (TONES Study)
The goal of this clinical trial is to learn if short electrical signals can be heard in adult subjects who are otherwise having surgery on their ear.
- Trial name
- NCT07402941
- Testing
- Electrical extracochlear stimulation
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Auricle Health Inc.
Cochlear Implants, Spatial Orientation
CI Spatial Orientation Study
The goal of this clinical trial is to learn if cochlear implant activation affects spatial orientation in cochlear implant users.
- Trial name
- CISPACE (NCT07510659)
- Testing
- Cochlear Implant
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Bilateral Vestibular Loss
VertiGO! - Get up and GO! With the Vestibular Implant
In the VertiGO! trial 13 participants with bilateral vestibulopathy (BV) and severe sensory neural hearing loss in the ear to be implanted will receive a combined cochlear (CI) and vestibular implant (VI), capable of stimulating…
- Trial name
- NCT04918745
- Testing
- Cochlear Vestibular Implant (CVI) - in-hosptial, Cochlear Vestibular Implant (CVI) - home-use (preference)
- Where
- Netherlands
- Volunteers
- 13 people
- Sponsor
- Maastricht University Medical Center
Cochlear Synaptopathy
A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
Like retinopathy, neuropathy and nephropathy, sensorineural hearing loss is a common and underserved complication of uncontrolled diabetes.
- Trial name
- RESPLAND (NCT07472907)
- Testing
- CIL001 (Paliroden)
- Volunteers
- 135 people
- Sponsor
- Cilcare SAS