Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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 assessments). Participants will be randomized to one of two surgical approaches: eRW or CO, with a 1:1 allocation in a parallel design.
Eligibility criteria
Qualifiers
Individuals aged 18 years and older who have clinically established post-linguistic sensorineural hearing loss.
CI candidate based on local or national reimbursement criteria.
Cochlear implantation with a CI632.
Preoperative 500 Hz pure-tone air conduction threshold <80 dB hearing level (HL) in the ear to be implanted.
Disqualifiers
Previous or existing CI recipient.
Ossification or other anatomical abnormalities of the cochlea or its windows possibly affecting normal electrode array insertion.
Abnormal cochlear nerve anatomy on preoperative CT or MRI.
Subjects who are unable to undergo CT or MRI.
Trial design
Treatments tested in this trial
- Surgical approach: cochleostomy or extended round window
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Radboud University Medical Center
Lead sponsor
GZA Ziekenhuizen Campus Sint-Augustinus
Collaborator
Universitaire Ziekenhuizen KU Leuven
Collaborator
Source ClinicalTrials.gov