ICF in Cochlear Implant Users
Launched by UNIVERSITY HOSPITAL, ANTWERP · Oct 26, 2020
Trial Information
Current as of May 13, 2025
Unknown status
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. General
- • Adults aged 18 years or older with postlingual HL
- • Signed and dated informed consent, informed permission and/or minors assent.
- • Willingness to participate in evaluations, test sessions, and medical follow-up sessions as defined in the protocol.
- • Physical and mental competence to participate in fitting of the device and follow-up sessions as defined in the protocol.
- • Fluency in the language of the implanting centre.
- • 2. Audiological
- • Completion of hearing assessment battery showing suitability of the CI candidates.
- • Compliance with cochlear implant candidate selection criteria of the implanting centre.
- • First cochlear implantation
- • 3. Medical
- • Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).
- Exclusion Criteria:
- • 1. General
- • Re-implantation of the cochlear implant
- • No motivation to participate in the study and/or unreasonable expectations.
- • 2. Medical
- • Presence of contra-indications for surgery in general and cochlear implantation in particular.
- • Presence of central auditory lesions.
- • Autoimmune disease, meningitis or ossification of the cochlea.
- • Radiological evaluation indicating malformation or obstruction of the cochlea.
- • Unstable psychological status.
- • Any disorder that may relate to an increased risk of skin flap problems
- • Having received chemotherapy
- • Be a burn victim
- • 3. Use of one of the following electrodes for implantation
- • Compressed
- • Split
- • Any type of custom made electrodes
About University Hospital, Antwerp
University Hospital Antwerp is a leading academic medical center dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the hospital fosters a collaborative environment that integrates cutting-edge scientific inquiry with state-of-the-art medical practices. As a prominent sponsor of clinical trials, University Hospital Antwerp is committed to enhancing medical knowledge and improving treatment outcomes across a wide range of specialties, leveraging its expertise to contribute significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Madrid, , Spain
Edegem, , Belgium
Perth, , Australia
Würzburg, , Germany
Kajetany, , Poland
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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