Status:

COMPLETED

FLI Normative Study

Lead Sponsor:

Cochlear

Collaborating Sponsors:

The Hearing Cooperative Research Centre

The Shepherd Centre

Conditions:

Hearing Loss

Eligibility:

All Genders

1-6 years

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 b...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

November 3 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

December 17 2018

Estimated Enrollment :

536 Patients enrolled

Trial Details

Trial ID

NCT03410017

Start Date

November 3 2017

End Date

December 17 2018

Last Update

October 29 2021

Active Locations (1)

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The MARCS Institute Western Sydney University

Milperra, New South Wales, Australia, 2214