Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Recruiting
N/A
Interventional Study
Cochlear Implants
Hearing Loss, Sensorineural
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- Radboud University Medical Center · Other
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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.
Trial Locations
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Eligibility 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…
Contacts