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NCT06841900

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

Sponsor: University Hospital, Antwerp

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-03

Completion Date

2027-03

Last Updated

2025-02-28

Healthy Volunteers

No

Interventions

DEVICE

Cochlear Implantation

Standard cochlear implantation

Locations (6)

Fiona Stanley Fremantle Hospital Group

Perth, Australia

University Hospital Antwerp

Edegem, Belgium

University Clinic of Würzburg

Würzburg, Germany

World Hearing Centre

Warsaw, Poland

King Abdullah Ear Specialist Center (KAESC)

Riyadh, Saudi Arabia

Hospital La Paz

Madrid, Spain