Related Experiment Video
Updated: Jul 15, 2025
Electrically Evoked Stapedius Reflex Measurements in Cochlear Implantation and Its Application in the Postoperative Fitting Process
Published on: June 21, 2024
A monocenter, patient-blinded, randomized, parallel-group, non-inferiority study to compare cochlear implant
Laura M Markodimitraki1,2, Timen C Ten Harkel3, Edwin Bennink4
1Department of Otorhinolaryngology and Head & Neck Surgery, University Medical Center Utrecht, G.05.1.29, P.O. Box 85500, 3508 GA, Utrecht, the Netherlands. l.m.markodimitraki-3@umcutrecht.nl.
Background:
During the cochlear implantation procedure, the receiver/stimulator (R/S) part of the implant is fixated to prevent postoperative device migration, which could have an adverse effect on the position of the electrode array in the cochlea. We aim to compare the migration rates of two fixation techniques, the bony recess versus the subperiosteal tight pocket without bony sutures.
Methods And Analysis:
This single-blind randomized controlled trial will recruit a total of 112 primary cochlear implantation adult patients, eligible for implantation according to the current standard of practice. Randomization will be performed by an electronic data capture system Castor EDC, with participants block randomized to either bony recess or standard subperiosteal tight pocket in a 1:1 ratio, stratified by age. The primary outcome of this study is the R/S device migration rate; secondary outcomes include patient-experienced burden using the validated COMPASS questionnaire, electrode migration rate, electrode impedance values, speech perception scores, correlation between R/S migration, electrode array migration and patient complaints, assessment of complication rates, and validation of an implant position measurement method. Data will be collected at baseline, 1 week, 4 weeks, 8 weeks, 3 months, and 12 months after surgery. All data analyses will be conducted according to the intention-to-treat principle.
Discussion:
Cochlear implantation by means of creating a tight subperiosteal pocket without drilling a bony seat is a minimally invasive fixation technique with many advantages. However, the safety of this technique has not yet been proven with certainty. This is the first randomized controlled trial that directly compares the minimally invasive technique with the conventional method of drilling a bony seat.
Trial Registration:
Netherlands Trial Register NL9698. Registered on 31 August 2021.
