ICF in Cochlear Implant Users

Last updated: April 27, 2021
Sponsor: University Hospital, Antwerp
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Deafness

Hearing Impairment

Treatment

N/A

Clinical Study ID

NCT04611555
B3002020000137
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The current project proposes a multi-center prospective follow-up cohort study aiming to realize an international framework to classify human functioning and disability in Cochlear Implant (CI) recipients using a standardized ICF framework. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified to enable comparison of data across countries and health-care disciplines. Adult subjects (≥18 years old) eligible for cochlear implantation, considering the local criteria of reimbursement, will be assessed one month preoperatively and six months post the activation of the speech processor using three audiological examinations, evaluating the participants' localization abilities, speech recognition and hearing thresholds, and six questionnaires, each evaluating different aspects of daily life functioning and disability in hearing-impaired persons.

Eligibility Criteria

Inclusion

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-upsessions as defined in the protocol.
  • Physical and mental competence to participate in fitting of the device andfollow-up sessions as defined in the protocol.
  • Fluency in the language of the implanting centre.
  1. Audiological
  • Completion of hearing assessment battery showing suitability of the CIcandidates.
  • Compliance with cochlear implant candidate selection criteria of the implantingcentre.
  • First cochlear implantation
  1. Medical
  • Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/orMagnetic Resonance Imaging (MRI).

Exclusion

Exclusion Criteria:

  1. General
  • Re-implantation of the cochlear implant
  • No motivation to participate in the study and/or unreasonable expectations.
  1. Medical
  • Presence of contra-indications for surgery in general and cochlear implantationin 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
  1. Use of one of the following electrodes for implantation
  • Compressed
  • Split
  • Any type of custom made electrodes

Study Design

Total Participants: 100
Study Start date:
August 31, 2020
Estimated Completion Date:
June 30, 2022

Connect with a study center

  • Fiona Stanley Fremantle Hospital Group

    Perth,
    Australia

    Site Not Available

  • University Hospital Antwerp

    Edegem,
    Belgium

    Active - Recruiting

  • University Clinic of Würzburg

    Würzburg,
    Germany

    Site Not Available

  • World Hearing Centre

    Kajetany,
    Poland

    Site Not Available

  • Hospital La Paz

    Madrid,
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.