FLI Normative Study (FLI-P)

Cochlear

Status

Completed

Conditions

Hearing Loss

Treatments

Other: Functional Listening Index

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03410017

CLTD5703

Details and patient eligibility

About

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.

Full 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.

Enrollment

536 patients

Sex

All

Ages

1 day to 6 years old

Volunteers

No Healthy Volunteers

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.