Comparing two surgical methods for cochlear implants
Official title: 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
Run by Radboud University Medical Center · NCT06453343 · Data updated 2026-11-12
This study is testing which of two surgical methods for cochlear implants helps adults with severe hearing loss keep their natural hearing and improves their overall sound experience.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | November 2027 |
| Registry record updated | February 25, 2025 |
| Trial ID | NCT06453343 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with post-lingual sensorineural hearing loss who are eligible for cochlear implantation.
✕Probably not a fit
Patients with previous cochlear implants, anatomical abnormalities affecting electrode insertion, or other specific auditory conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial is a prospective multicenter randomized control trial aimed at comparing two surgical approaches to cochlear implantation: cochleostomy (CO) and extended round window (eRW). The study will involve adult candidates with severe to profound post-lingual sensorineural hearing loss, who will be randomly assigned to one of the two surgical techniques. The trial will assess the impact of these approaches on preserving residual hearing and minimizing intracochlear trauma over a one-year follow-up period, utilizing pure tone audiometry, electrocochleography, and imaging techniques. The goal is to determine which method better supports natural sound perception and enhances auditory outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques that better preserve hearing in cochlear implant patients.
How similar studies have gone: Previous studies have shown varied results when comparing different surgical approaches, indicating that this area of research is both relevant and necessary.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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. * Deafness due to acoustic nerve or central auditory pathway lesions. * Diagnosis of auditory neuropathy. * Active middle ear infection. * 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.
Where it's running
-
Radboud University Medical Center
Nijmegen, Netherlands Recruiting
Study contacts
- Study coordinator: Coby Lindeboom, MD
- Email: Coby.lindeboom@radboudumc.nl
- Phone: 024 361 14934
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.