Clinical Trial to Compare Two Surgical Approaches to the Cochlea

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jun 10, 2024

Keywords

ClinConnect Summary

This clinical trial is comparing two different surgical methods for placing cochlear implants, which are devices that help people with hearing loss. The study aims to understand which approach might work better for individuals who have significant hearing loss due to damage in the inner ear. Participants will be followed for about one year, with check-ins before surgery and at one week, three months, and twelve months after the procedure.

To be eligible for this study, participants must be at least 18 years old and have a specific type of hearing loss called post-linguistic sensorineural hearing loss, meaning they lost their ability to hear after learning to speak. They should be suitable candidates for cochlear implants based on local guidelines and meet certain hearing test criteria. The trial is currently recruiting individuals and is open to people of all genders. It's important to note that anyone who has had a cochlear implant before or has certain medical conditions affecting the ear may not be able to participate. Participants will need to provide consent and can expect close monitoring throughout the study to help researchers gather valuable information on the effectiveness of these surgical approaches.

Gender

ALL

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 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.