Hearing LossFLI-PNCT03410017
FLI Normative Study
An observational study of Hearing Loss, run by Cochlear at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 1 day to 6 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Functional Listening Index
- How many people
- 536 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Nov 2017to 17 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 6 years
- All sexes
- Child
Study population: Up to 700 normally-hearing children aged between 0 to 6 years of age.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The MARCS Institute Western Sydney University
Milperra, New South Wales, 2214
About this study
Official title: Normative Data for the Functional Listening Index - Paediatric
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Functional Listening Index
- Keywords
- Functional Listening Index
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Listening IndexOther
Functional Listening Index questionnaire to assess acquisition of listening skills.
| Study group | Role | What they receive |
|---|---|---|
| Normally-hearing | Children with normal hearing Receives: Other: Functional Listening Index |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start3 Nov 2017
- Primary completion8 Oct 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Hearing Cooperative Research Centre, The Shepherd Centre
- Responsible party
- Sponsor
- Investigators
- Aleisha Davis, MLSP, Principal investigator, The Hearing Cooperative Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410017
- Sponsor's protocol ID
- CLTD5703
- Acronym
- FLI-P
- Status last verified
- Oct 2021
- First submitted
- 1 Oct 2017
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Data for the Functional Listening Index - Paediatric
- ClinicalTrials.gov ID
- NCT03410017
- Acronym / sponsor ID
- FLI-P / CLTD5703
- Conditions
- Hearing Loss
- Keywords
- Functional Listening Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- The Hearing Cooperative Research Centre, The Shepherd Centre
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 25 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normally-hearing | – | Other: Functional Listening IndexChildren with normal hearing |
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Up to 700 normally-hearing children aged between 0 to 6 years of age.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Listening IndexFunctional Listening Index questionnaire to assess acquisition of listening skills. | Other | Normally-hearing |
Primary outcome
Functional Listening Index
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Individual participant dataSharing planned: No
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A Study Testing the Safety and Possible Benefits of an Ear Injection of a New Compound, Paliroden, in People With Type 2 Diabetes Who Have Difficulty Understanding Speech in Noisy Situations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleisha Davis, MLSP principal investigator
The Hearing Cooperative Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Cochlear at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Listening Index (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021; AzTrials last refreshed its copy on 27 Oct 2026.