Actively Recruiting
Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Led by Radboud University Medical Center · Updated on 2025-02-25
50
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
G
GZA Ziekenhuizen Campus Sint-Augustinus
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial to Compare Two Surgical Approaches to the Cochlea
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Previous or existing cochlear implant recipient.
- Ossification or anatomical abnormalities of the cochlea or its windows that may affect electrode insertion.
- Abnormal cochlear nerve anatomy on preoperative CT or MRI.
- Unable to undergo CT or MRI scans.
- Deafness caused by acoustic nerve or central auditory pathway lesions.
- Diagnosis of auditory neuropathy.
- Active middle ear infection.
- Additional handicaps preventing participation in study evaluations.
- Unrealistic expectations about the benefits, risks, or limitations of the cochlear implant procedure.
- Employment by Cochlear or related contractors involved in this investigation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
Research Team
C
Coby Lindeboom, MD
CONTACT
E
Emmanuel Mylanus
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here