Clinical Trial to Compare Two Surgical Approaches to the Cochlea

Recruiting now · Not applicable

Conditions studied: Cochlear Implants, Hearing Loss, Sensorineural

In brief

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.

Key facts

Study ID

NCT06453343

Run by

Radboud University Medical Center

People needed

50

Starts

2025-01-01

Expected to finish

2027-11-01

Last updated by the study team

2025-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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 is running

• Radboud University Medical Center — Nijmegen, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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