cochlear implant surgical techniques
Conditions
Interventions
The R/S device of the CI will be fixated according to the respective group the
patient has been allocated in. All patients will undergo a Cone Beam CT (CBCT)
scan within 48 hours after surgery and a
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • The patient has provided written informed consent authorization before participating in the study. • The patient is >=18 years of age at the time of consent. • The patient is a primary cochlear implantation candidate according to all standard care criteria. • The patient has Dutch written language proficiency. • The patient is physically able to undergo a CBCT scan.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Revision surgery • Re-implantation • Other applied techniques than mentioned in the materials and methods • Inability to understand or sign informed consent • Pregnancy during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Migration of the R/S device, measured in millimetres and degrees. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: - COMPASS questionnaire scores - Electrode array migration - Electrode impedance values - Audiological results (cvc wordtest score) - Complication rates | — |
Countries
Netherlands
Outcome results
None listed