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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cochlear Impant Children
• Intervention / Treatment: Device: Cochlear Implantation

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Ellen Andries, PhD AUD; Phone Number: +32 3 275 7372; Email: ellen.andries@uza.be
• Study Contact Backup: Name: Griet Mertens, PhD AUD; Email: griet.mertens@uza.be

Study Locations

• Australia
  • Perth, Australia
    • Fiona Stanley Fremantle Hospital Group
    • Contact: Dayse Tavora-Viera; Phone Number: +61 8 6488 4880; Email: dayse.tavora@gmail.com
    • Contact: Aanand Acharya
    • Contact: Dayse Tavora-Viera
• Belgium
  • Edegem, Belgium, 2650
    • University Hospital Antwerp
    • Contact: Griet Mertens; Email: griet.mertens@uza.be
    • Contact: Ellen Andries; Phone Number: +32 3 275 7372; Email: ellen.andries@uza.be
    • Contact: Griet Mertens
    • Contact: Vincent Van Rompaey
    • Contact: Paul Van de Heyning
• Germany
  • Würzburg, Germany
    • University Clinic of Würzburg
    • Contact: Anja Kurz; Phone Number: +49 - 931 201 21701; Email: Kurz_A@ukw.de
    • Contact: Anja Kurz
    • Contact: Rudolf Hagen
• Poland
  • Warsaw, Poland
    • World Hearing Centre
    • Contact: Artur Lorens; Phone Number: 954-404-6477; Email: a.lorens@ifps.org.pl
    • Contact: Artur Lorens
    • Contact: Piotr Skarzynski
    • Contact: Henryk Skarzynski
• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Abdullah Ear Specialist Center (KAESC)
    • Contact: Medhat Yousef; Phone Number: +966 1 4670888; Email: myousef@ksu.edu.sa
    • Contact: Medhat Yousef
    • Contact: Abdulrahman Hagr
• Spain
  • Madrid, Spain
    • Hospital La Paz
    • Contact: Miryam Calvino; Phone Number: +34 917 27 70 00; Email: miryamcf@yahoo.com
    • Contact: Miryam Calvino
    • Contact: Luis Lasaletta
    • Contact: Javier Gavilan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cochlear Implant (CI) recipients (<18 years) with prelingual sensorineural hearing loss	Device: Cochlear Implantation; Standard cochlear implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LittlEARS® Auditory Questionnaire (LEAQ)	The LittlEARS® Auditory Questionnaire (LEAQ) was created to aid professionals and caregivers in the assessment of auditory capabilities among infants and toddlers experiencing hearing impairment. Grounded in the observations made by caregivers concerning the auditory responses exhibited by their children in everyday settings, this questionnaire comprises 35 questions tailored to specific age groups, necessitating responses of either 'yes' or 'no'. These questions are designed to capture significant milestones in auditory development during the initial two years of life or within the first two years following the onset of hearing intervention for children utilizing hearing devices. The questionnaire is suitable for children up to 24 months old, or with a hearing age of 24 months.	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Parent's Evaluation of Aural/Oral Performance of Children (PEACH)	The PEACH is a 13-item questionnaire designed for parental assessment of a 3- to 7-year-old child's aural and oral abilities in everyday life. The PEACH asks parents to consider their child's listening behaviors over the past week and then assigns a numerical value to the answers ranging from 0 (Never or 0 %) to 4 (Always or 75 to 100 %). The PEACH questions assess listening behaviors in both quiet and noisy surroundings.	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Auditory Brainstem Response (ABR) Audiometry	ABR audiometry involves the generation of an evoked potential through a brief auditory stimulus (e.g., click, chirp, etc.) transmitted via an acoustic transducer (insert earphone or headphone). The resulting waveform response is detected by surface electrodes positioned at the vertex of the scalp and ear lobes. The signal's amplitude is averaged and plotted against time and waveform peaks are identified as I-VII. These waveforms typically occur within a 10-millisecond window following a click stimulus presented at high intensities (70-90 dB normal hearing level [nHL]). ABR audiometry is suitable for children of all ages.	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Ling Sounds (detection/discrimination)	For Ling sound detection, the participants' detection of six sounds (oo, ah, ee, mm, sh, ss) will be observed in a variety of game formats. In the clinic, each sound is presented six times without lipreading, and the child simply responds. Score "S" will be given if the skill is emerging, score "A" will be given if the child has been observed to carry out the tasks consistently. For Ling discrimination, the phoneme "ee" will be repeated and all six Ling Sounds will be randomly inserted. Score "S" will be given if the child is consistently able to discriminate any one sound out of the six, score "A" will be given if the child is consistently able to discriminate all six sounds. The Ling test is suitable for children from approximately 6 months of age to adulthood.	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Change in Speech, Spatial and Qualities of Hearing Scale for Parents (SSQ-P)	The original SSQ was adapted for use in children, resulting in the development of the SSQ-P. Each of the 23 items in the questionnaire presents a scenario followed by a question regarding the child's hearing ability within that scenario. These items are categorized into three dimensions: speech perception, spatial hearing, and qualities of hearing. Parents are tasked with providing a rating between 0 and 10 for each item, where 0 signifies that the child could not perform in the scenario at all and 10 indicates perfect performance. Additionally, parents are asked to indicate how frequently the scenario would occur and to rate the importance of the listening skills required for that scenario.	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Change in Speech Intelligibility Rating (SIR)	The Speech Intelligibility Rating (SIR) comprises spoken passages, wherein the degree of intelligibility is evaluated using an interval scale spanning from 0 to 10, ensuring uniformity in rating perception. The SIR assessment uses 20 standardized passages delivered by a single speaker, each identified as possessing comparable levels of intelligibility. The SIR is typically used in children with hearing loss from around the age of 2 years old .	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor
Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry	Standard pure tone audiometry, Behavioral Observation Audiometry (BOA), Visual Reinforcement Audiometry (VRA) or Play Audiometry will be performed according to current clinical standards (ISO 8253-1, 2010), depending on the age of the participant. Pre- and postoperatively, best-aided audiometry will be measured at 250, 500, 1000, 2000, 4000 and 8000 Hz using warble tones in sound field in a sound treated booth. The loudspeaker will be placed in front of the participant at ear level at 1 meter distance. The best-aided pure tone average (PTA4, primary outcome measurement) will be calculated by averaging participants' hearing thresholds at 500, 1000, 2000 and 4000 Hz in best-aided condition.	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Demographics	Subject demographics will be retrieved from the participants' medical file or by asking the parents if the information is not available. The 11th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-11) classification will be used to code subjects' health conditions.	1 month before implantation and 3 months, 6 months and 1 year post the activation of the speech processor

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: ICF in Paediatric CI users

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No