Clinical Trial to Compare Two Surgical Approaches to the Cochlea (NCT06453343) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Netherlands50 participantsStarted 2025-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.