FLI Normative Study

Completed

• Conditions: Hearing Loss
• Interventions: Other: Functional Listening Index

• Registration Number: NCT03410017
• Lead Sponsor: Cochlear

Brief Summary

Single center, cross sectional observational research design to collect normative data on the acquisition of listening skills in normally-hearing children aged 0-6 years of age.

Detailed Description

The primary objective is the assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P). The FLI-P has been developed to address a substantial gap in the current tools available to measure the development of auditory skills in children. The FLI-P provides a measure of listening skills acquisition in children from birth to six years of age (0 - 72 months). The FLI-P will be administered by an investigator who has received appropriate training in its use or completed by parents/caregivers themselves. The FLI-P assessment will be conducted using an application running on a Personal Computer, tablet or online device. There are no specific medical or surgical procedures involved in this clinical investigation and the FLI-P is a non-interventional application.

Study Timeline

• Study First Submitted: 2017-10-01
• Study Start: 2017-11-03
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-25
• Primary Completion: 2018-10-08
• Study Completion: 2018-12-17
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 536

Inclusion Criteria

• Children aged between 0 and 6 years of age.
• Pass on the Newborn Hearing Screen Status conducted during the New South Wales Statewide Infant Screening - Hearing (SWISH) Program.
• No current parental or professional concern regarding hearing status.

Exclusion Criteria

• Pre-existing diagnosis of additional needs.
• Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of the study.
• Unwillingness or inability of the subject to comply with all investigational requirements.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normally-hearing	Functional Listening Index	Children with normal hearing

Primary Outcome Measures

Name	Time	Method
Functional Listening Index	1 day	The assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P).

Trial Locations

Locations (1)

The MARCS Institute Western Sydney University; 🇦🇺 Milperra, New South Wales, Australia