Clinical trials: Cochlear Implant Surgery
Hearing Loss - Conductive
Stability of the Cochlear Baha BI300/BA400 Implant System Loaded From 1 Week Post-surgery
Objectives To evaluate the safety of processor loading of the Cochlear BI300/BA400 implant system 1 week after implantation To evaluate the short term soft tissue healing and the long term skin reaction, with the new Cochlear…
- Trial name
- NCT02096809
- Testing
- One week loading of Bone Anchored Hearing Aid (BAHA), Cochlear Baha BI300/BA400 Implant System
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- Aarhus University Hospital
Sensorineural Hearing Loss
Hearing Preservation in Cochlear Implantation Surgery
In order to preserve the residual hearing in patients with sensorineural hearing loss (SNHL) receiving a cochlear implant (CI), the insertion trauma to the delicate and microscopic structures of the cochlea needs to be minimized.
- Trial name
- CIPRES (NCT07146841)
- Testing
- Round window insertion, Cochleostomy insertion, Lateral wall array
- Where
- Netherlands
- Volunteers
- 48 people
- Sponsor
- UMC Utrecht
Tympanostomy Tube Insertion
Prediciton of the Round Window Visibility Through Posterior Tympanotomy by CT Scan Analysis
It is difficult to predict the intraoperative visibility of the round window through the posterior Tympanostomy. In case of non-visualization, the surgeon may have to change operative technique during cochlear implant surgery.
- Trial name
- NCT03589209
- Where
- France
- Volunteers
- 100 people
- Sponsor
- University Hospital, Strasbourg, France
Hearing Loss
Intracochlear Application of VSF1.01 for the Reduction of Cochlear Implant Surgery Related Trauma
The goal of this clinical trial is to assess the safety of intracochlear application of VSF1.01 for the reduction of cochlear implant surgery related trauma in patients with profound hearing loss with or without non-functional…
- Trial name
- ESCRT (NCT06545175)
- Testing
- Intracochlear application of VSF1.01
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Hannover Medical School
Sensorineural Hearing Loss, Cochlear Implant
Cochlear Electrical Impedance and the Effect of Topical Dexamethasone on Cochlear Implant Surgery
Hearing is the ability to perceive sounds through the ear. If the transmission of sound is defective, the person suffers some degree of hearing loss.
- Trial name
- NCT03374514
- Testing
- Dexamethasone, Sterile isotonic saline solution
- Where
- Argentina
- Volunteers
- 20 people
- Sponsor
- Hospital Italiano de Buenos Aires
Severe to Profound Sensorineural Hearing Loss, Undergoing Cochlear Implant Surgery
Radiological Classification of the Facial Nerve
Cortical mastoidectomy and posterior tympanotomy is a classic approach for cochlear implant. Intimate knowledge of the relevant surgical anatomy of the temporal bone and facial recess is important to safely perform the posterior…
- Trial name
- NCT02925208
- Testing
- cochlear implant surgery
- Where
- Saudi Arabia
- Volunteers
- 140 people
- Sponsor
- Imam Abdulrahman Bin Faisal University
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
Cochlear Implantation
Impact of the Surgical Experience on Cochleostomy Location: A Comparative Temporal Bone Study Between Endaural and Posterior Tympanotomy Approaches for Cochlear Implantation
The goal of this study was to evaluate, in the hands of an inexperienced surgeon, the cochleostomy location of an endaural approach (MINV) compared to the conventional posterior tympanotomy (MPT) approach.
- Trial name
- NCT02902497
- Volunteers
- 24 people
- Sponsor
- Centre Hospitalier Universitaire de Nice
Hearing Loss, Cochlear, Cochlear Implantation
Post-Market Clinical Investigation of the IotaSOFT Insertion System
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
- Conditions
- Hearing Loss, Cochlear, Cochlear Implantation, Hearing Loss, Sensorineural
- Trial name
- ACE (NCT06664697)
- Testing
- Cochlear Implantation with Robotic-Assisted Insertion System
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- iotaMotion, Inc.
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
Deafness
First Clinical Evaluation of HEARO Robotic Cochlear Implantation Surgery in Austria
To demonstrate the efficacy of a minimally invasive direct cochlear access via the HEARO procedure in cochlear implantation.
- Trial name
- HEARO-AT (NCT04795986)
- Testing
- HEARO Procedure
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Medical University of Vienna
Sensorineural Hearing Loss, Bilateral
Study of a Minimally Invasive Cochlear Access for Cochlear Implantation Via a Robotic Procedure
The objectives of this study are to explore the efficacy and safety of a robotic procedure for a minimally invasive cochlear implantation.
- Trial name
- NCT04777565
- Testing
- Robotic surgery
- Where
- France
- Volunteers
- 10 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Sensorineural Hearing Loss, Deafness
Cochlear Implant and Vestibular Function.
This study investigate weather one type of cochlear implant (CI) surgery (insertion of the electrode via paracentesis of the round window (RWA)) leads to less vertigo than another type of CI surgery (cochleostomy).
- Conditions
- Sensorineural Hearing Loss, Deafness, Hearing Loss
- Trial name
- NCT02584361
- Testing
- Round window approach, Cochleostomy
- Where
- Denmark
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Hearing Loss, Sensorineural, Hearing Loss, Cochlear
The Neuro Zti Cochlear Implant System Efficacy and Safety in Adults
The purpose of the study is to assess the efficacy and the safety profile of the Neuro Cochlear Implant System (CIS) in adults with severe-to-profound hearing loss.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Deafness
- Trial name
- NCT02941627
- Testing
- Neuro Zti, Neuro One
- Where
- 6 sites in Canada, Denmark
- Volunteers
- 53 people
- Sponsor
- Oticon Medical
CHARGE Syndrome
A Strategic Approach to Safe and Effective Cochlear Implantation in Patients With CHARGE Syndrome
This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome.
- Trial name
- NCT07320482
- Testing
- No intervention (observational study)
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Bundang Hospital
Tractography, Cochlear Implant
Predictive Study on Hearing Rehabilitation After Cochlear Implant
The aim of this study is to display the predictive factors of hearing rehabilitation after cochlear implant surgery in severely to profoundly deaf adults.
- Conditions
- Tractography, Cochlear Implant, Magnetic Resonance Imaging, Hearing Rehabilitation
- Trial name
- NCT06086041
- Testing
- cochlear implant
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Grenoble
Hearing Loss, Conductive
Comparative Study of Two Surgical Techniques for Soft Tissue Healing and Implant Stability of Cochlear BI300 Implants.
The study compares two different operative techniques for placement of the Cochlear Bi300 implant to be used for bone anchored hearing aid.
- Trial name
- NCT01699620
- Testing
- BAHA implant insertion
- Where
- Denmark
- Volunteers
- 49 people
- Sponsor
- Aarhus University Hospital
Cochlear Implants, Hearing Preservation
Exploring the Use of ECochG Testing During Electrode Insertion in Cochlear Implant Surgery
Investigation of a new ECoChG system (Electrocochleography) during the surgical insertion of cochlear implants, for patients with Advanced Bionics devices.
- Trial name
- NCT03807830
- Testing
- Electrocochlography
- Where
- United Kingdom
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
Vestibular Schwannoma, Hearing Loss
Intraoperative EABR for Decision Making
In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.
- Trial name
- NCT03745560
- Where
- Austria
- Volunteers
- 15 people
- Sponsor
- Christoph Arnoldner
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