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Search / Trial NCT04611555

ICF in Cochlear Implant Users

Launched by UNIVERSITY HOSPITAL, ANTWERP · Oct 26, 2020

Trial Information

Current as of May 13, 2025

Unknown status

Keywords

Cochlear Implantation International Classification Of Functioning, Disability And Health

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.

Locations

Madrid, , Spain

Edegem, , Belgium

Perth, , Australia

Würzburg, , Germany

Kajetany, , Poland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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