Clinical Trial to Compare Two Surgical Approaches to the Cochlea
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
Radboud University Medical Center
50 participants
Jan 1, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria10
- 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.
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Interventions
Surgical placement of a cochlear implant electrode array
Locations(1)
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NCT06453343