FLI Normative Study

Normative Data for the Functional Listening Index - Paediatric

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03410017

Acronym

FLI-P

Enrollment

536

Registered

2018-01-25

Start date

2017-11-03

Completion date

2018-12-17

Last updated

2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

Keywords

Functional Listening Index

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.

Interventions

OTHERFunctional Listening Index

Functional Listening Index questionnaire to assess acquisition of listening skills.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 6 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026