FLI Normative Study

Hearing Loss Clinical Trial

— FLI-P  

Official title:

Normative Data for the Functional Listening Index - Paediatric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03410017
• Other study ID #: CLTD5703
• Status: Completed
• Start date: November 3, 2017
• Est. completion date: December 17, 2018

Study information

• Verified date: October 2021
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: December 17, 2018
• Est. primary completion date: October 8, 2018
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Other:
• Functional Listening Index
Functional Listening Index questionnaire to assess acquisition of listening skills.

Locations

Country	Name	City	State
Australia	The MARCS Institute Western Sydney University	Milperra	New South Wales

Sponsors (3)

Lead Sponsor	Collaborator
Cochlear	The Hearing Cooperative Research Centre, The Shepherd Centre

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Listening Index	The assessment of listening skill acquisition in normally-hearing children aged between 0 and 6 years with the Functional Listening Index - Paediatric (FLI-P).	1 day