Sensorineural hearing loss, deafness
Conditions
Interventions
Subperiosteal tight pocket fixation technique.
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
Inclusion 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: • Revision surgery • Re-implantation • Inability to understand or sign informed consent • Pregnancy during the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to compare the migration rates of the two fixation techniques (bony bed vs. subperiosteal tight pocket) by analysing 3D reconstructions of the R/S device, acquired by Cone Beam CT (CBCT) scans at baseline and during follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To investigate the difference in patient-experienced burden using the validated COMPASS questionnaire between the two fixation techniques. • To compare the electrode array migration rate between the two techniques. • To compare electrode impedance values between the two techniques and association with R/S device and electrode migration. • To investigate whether complaints of performance drop, vertigo, tinnitus, headache or nonauditory stimulation are associated with electrode array migration and R/S device migration. • To compare the complication rate of these surgical techniques, for major and minor complications. • To assess the diagnostic accuracy and validate the measurement method technique with flexible tape measure for the assessment of migration of the R/S device. | — |
Contacts
Public ContactLaura Markodimitraki
UMC Utrecht
Outcome results
None listed