Cochlear implant receiver/stimulator fixation with and without drilling; a randomized controlled study

Recruiting

Conditions: Sensorineural hearing loss, deafness

Registration Number: NL-OMON28350

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 112

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

•Revision surgery
•Re-implantation
•Inability to understand or sign informed consent
•Pregnancy during the trial

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
•To investigate the difference in patient-experienced burden using the validated COMPASS questionnaire between the two fixation techniques.<br>•To compare the electrode array migration rate between the two techniques.<br>•To compare electrode impedance values between the two techniques and association with R/S device and electrode migration.<br>•To investigate whether complaints of performance drop, vertigo, tinnitus, headache or nonauditory stimulation are associated with electrode array migration and R/S device migration.<br>•To compare the complication rate of these surgical techniques, for major and minor complications.<br>•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.