NCT06841900

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

Implementation of the International Classification of Functioning, Disability and Health Model in Paediatric Cochlear Implant Recipients: a Multi-center Prospective Follow-up Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cochlear Impant Children

Interventions

Type	Name	Description
DEVICE	Cochlear Implantation	Standard cochlear implantation

Timeline

• Start date: 2025-03-01
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-02-24
• Last updated: 2025-02-28

Locations

6 sites across 6 countries: Australia, Belgium, Germany, Poland, Saudi Arabia, Spain