Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients

Antwerp University Hospital (UZA)

Status: Not yet enrolling

Conditions: Cochlear Impant Children

Treatments: Device: Cochlear Implantation

Study type: Observational

Funder types: Other

Identifiers

NCT06841900

ICF in Paediatric CI users

Details and patient eligibility

About

The aim of this study is to implement the International Classification of Functioning, disability and health (ICF) in paediatric Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss in a multicenter prospective study to evaluate audiological rehabilitation after cochlear implantation. For this, ICF qualifiers which denote the magnitude of the level of health or severity of the problem will be quantified. Outcome measures include four questionnaires and three standard audiological examinations. Subjects will be assessed up to 1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor.

Enrollment: 120 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

General

• Children aged < 18 years with prelingual bilateral severe-to-profound HL
• Signed and dated informed consent, informed permission and/or minor's 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.

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 Medical
• Patent cochlea, as evidenced by High-resolution computed tomography (HRCT) and/or Magnetic Resonance Imaging (MRI).

Exclusion criteria

General

• Re-implantation of the cochlear implant
• No motivation to participate in the study and/or unreasonable expectations. Medical
• Presence of contra-indications for surgery in general and cochlear implantation in particular.
• Presence of central auditory lesions.
• Any disorder that may relate to an increased risk of skin flap problems Use of one of the following electrodes for implantation
• Compressed
• Split
• Any type of custom made electrodes

Trial design

120 participants in 1 patient group

Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss

Description:

Cochlear Implant (CI) recipients (\<18 years) with prelingual sensorineural hearing loss

Treatment:

Device: Cochlear Implantation