Clinical trials: Cochlear Implant Surgery
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.
Sensorineural Hearing Loss (Disorder)
Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery
The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in…
- Trial name
- NCT02093806
- Testing
- measurment
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Bnai Zion Medical Center
Unilateral Acoustic Neuroma, Meniere's Disease
Cochlear Implantation After Labyrinthectomy or a Translabyrinthine Surgical Approach
The goal of this project is to determine whether subjects who have undergone labyrinthectomy or a translabyrinthine surgical approach as the treatment for vestibular schwannoma or Meniere's disease benefit from cochlear…
- Trial name
- NCT02309099
- Testing
- Cochlear Implant
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of North Carolina, Chapel Hill
Otolaryngological Diseases Requiring Mastoidectomy, Middle Ear Surgery, Endolymphatic Sac Surgery, Cochlear Implant, Labyrinthectomy, Petrous Apex Lesions, Facial Nerve Surgery, and Lateral Skull Base Tumors
AI Recognition of Important Structures in Otolaryngological Surgery
Developing a system for artificial intelligence to recognize anatomical landmarks in otolaryngological surgery, enabling real-time tracking of critical temporal bone structures during surgery.
- Trial name
- NCT06726551
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sevoflurane, Propofol
Effects of Propofol and Sevoflurane on Blood Folic Acid and Homocysteine Concentrations in Children
To investigate the effect of sevoflurane and propofol on the concentrations of serum homocysteine and folic acid in children who received cochlear implant surgery.
- Conditions
- Sevoflurane, Propofol, Homocysteine, Cochlear Hearing Loss
- Trial name
- NCT03595163
- Testing
- Sevoflurane, Propofol
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Tinnitus, Subjective, Tinnitus, Bilateral
Tinnitus Patient Preferences Survey
The goal of this survey is to assess several aspects related to patient preferences regarding interventions for alleviating tinnitus through invasive electrical brain stimulation (neuromodulation).
- Conditions
- Tinnitus, Subjective, Tinnitus, Bilateral, Tinnitus, Noise Induced, Tinnitus, Hearing Loss, Cochlear Implant Users
- Trial name
- NCT06782308
- Testing
- Survey using a questionnaire.
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Nicolas Gninenko
Deafness
Intraoperative Electrically-evoked ABRs in Patients Undergoing Vestibular Schwannoma Surgery
This is a study of the feasibility of activating the auditory system by an electrode in direct contact with the cochlear nerve.
- Trial name
- NCT05248113
- Testing
- Electrical stimulation of cochlear nerve
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, Irvine
Sensorineural Hearing Loss
Clinal Evaluation of Navigation Based Functional Ear Surgery Using Image Guided and Robotically Assisted Techniques
To assess the feasibility of achieving a minimally invasive access to the inner ear through the navigation-based HEARO procedure and subsequently insert the electrode array of the cochlear implant through the access.
- Trial name
- EAR2OS (NCT03746613)
- Testing
- HEARO
- Where
- Belgium
- Volunteers
- 3 people
- Sponsor
- Prof. Vedat Topsakal
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
Anesthesia, Local
Local Anesthesia for Pediatric Cochlear Implant
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain.
- Trial name
- NCT03721081
- Testing
- Lidocaine 1%/Epi 1:200000, Na Cl 0.9%/Epi 1:200000
- Where
- Egypt
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Wahba bakhet
Cochlear Implants, Evoked Potentials, Auditory
Optimization of Cochlear Implant MAP-parameters in Children
This project will complete a long-term follow up for children that have received cochlear implants (CI) early in life and had their CI's programmed based on objective measurements.
- Conditions
- Cochlear Implants, Evoked Potentials, Auditory, Child, Disabilities Hearing
- Trial name
- NCT03694340
- Testing
- Re-programming of cochlear implant
- Where
- Sweden
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Göteborg University
Vestibular Schwannoma, Meniere Disease
CI Following VS Removal or Labyrinthectomy
This study is a prospective, clinical study to determine if it is safe and effective to use a cochlear implant over time in individuals undergoing removal of a vestibular schwannoma (VS), benign tumor of the hearing and balance…
- Trial name
- NCT03795675
- Testing
- Cochlear Implant
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Ohio State University
Tympanomastoid Surgery, Cochlear Implant
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing…
- Conditions
- Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma
- Trial name
- NCT01638052
- Testing
- 0.25% Bupivacaine + Clonidine
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Hearing Loss
Percutaneous Cochlear Implantation: Implementation of Technique
The investigators are studying a new way of doing cochlear implant surgery called "Percutaneous Cochlear Implantation". In this surgery, instead of doing a mastoidectomy where about 30ml of bone is removed, the investigators use…
- Trial name
- PCI-I (NCT01460823)
- Testing
- Percutaneous Cochlear Implantation using image guided surgical techniques
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Vanderbilt University
Cochlear Implant Surgery
Local Anesthesia With Sedation for Cochlear Implant Surgery
ABSTRACT Objectives: The aim of this article is to illustrate the possibility of performing a cochlear implant with local anesthesia and sedation, the anesthesic technique and the advantages of that in comparison to a general…
- Trial name
- IC (NCT01033890)
- Where
- Brazil
- Volunteers
- 3 people
- Sponsor
- Instituto Paranaense de Otorrinolaringologia
Deafness
Prospective Study of Round Window Versus Cochleostomy Approach to CI Surgery
To the investigators' knowledge, no clinical study has prospectively investigated the relationship between surgical insertion technique, intracochlear electrode location, and postoperative hearing outcomes.
- Trial name
- NCT02466763
- Testing
- Cochlear implant surgery
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Mayo Clinic
Cochlear Implantation
Radiologic Criteria for Round Window Visibility Prediction in Cochlear Implantation
The aim of the study is to identify the scannographic criterion the most relevant to predict the round window visibility during cochlear implantation.
- Trial name
- R-PO18155 (NCT03950375)
- Where
- France
- Volunteers
- 23 people
- Sponsor
- CHU de Reims
Vestibular Function in Cochlear Implant Patients
Vestibular Function After Cochlear Implantation Using Soft Surgery Techniques
This study will measure the effects of soft surgical techniques on vestibular function and quality of life in patients pre- and post-cochlear implant (CI) surgery.
- Trial name
- NCT02503592
- Testing
- Vestibular testing
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Duke University
Cochlear Implants, Hearing Loss, Sensorineural
Clinical Trial to Compare Two Surgical Approaches to the Cochlea
This is a prospective multicenter multinational randomized control trial. The duration of the study for the individual patient will be approximately 1 year (pre-operative assessments, 1 week, 3 months and 12 months follow-up…
- Trial name
- BULLS-I (NCT06453343)
- Testing
- Surgical approach: cochleostomy or extended round window
- Where
- Netherlands
- Volunteers
- 50 people
- Sponsor
- Radboud University Medical Center
Cochlear Implantation, Monitoring Electrode Insertion
Evaluating a New Software (OTOGUIDE) to Help Monitor Electrode Insertion During Cochlear Implant Surgery.
Cochlear implants are a successful treatment for severe hearing loss in both children and adults. The procedure involves placing an electrode array into the cochlea to stimulate the auditory nerve, helping patients to hear.
- Trial name
- OGUID (NCT07690995)
- Testing
- OTOGUIDE software
- Where
- 2 sites in Austria, Germany
- Volunteers
- 42 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH