Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Key facts
- Where
- Nijmegen, NetherlandsSee the site
Where in Netherlands
- Radboud University Medical CenterNijmegen, NetherlandsContact: LindeboomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Radboud University Medical Center
- Trial code
- NCT06453343
- Record updated
- 25 February 2025
- Original description
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.Read full original descriptionShow less
Multicenter Randomized Controlled Trial Comparing Surgical Approaches to the Cochlea for the Slim Modiolar Electrode: Assessing Intracochlear Trauma Using Intraoperative Electrocochleography Measurements and Preservation of Residual Hearing
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.
Inclusion: 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; Willing and able to provide written informed consent.
Exclusion: Previous or existing CI recipient; Active middle ear infection; 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; Deafness due to acoustic nerve or central auditory pathway lesions; Diagnosis of auditory neuropathy; Additional handicaps that would prevent participation in study evaluations; Unrealistic expectations from the participant regarding the possible benefits, risks, and limitations inherent to the CI procedure and the investigation; Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.