Improving hearing tests for infants with hearing loss using brain imaging
Official title: Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
Run by The Bionics Institute of Australia · NCT05847426 · Data updated 2026-11-12
This study tests if a new brain imaging technique can help audiologists make better decisions for infants with hearing loss while also checking if parents find the testing comfortable and acceptable.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 24 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | The Bionics Institute of Australia Academic / other |
| Locations | 5 sites (East Melbourne, Victoria and 4 other locations) |
| Status | Recruiting |
| Started | May 2, 2023 |
| Main results expected | April 28, 2028 |
| Study ends | April 28, 2028 |
| Registry record updated | August 19, 2025 |
| Trial ID | NCT05847426 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants aged 1 to 24 months diagnosed with permanent hearing loss in one or both ears.
✕Probably not a fit
Patients who do not have permanent hearing loss or are outside the age range of 1 to 24 months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to determine if functional near-infrared spectroscopy (fNIRS) can enhance the decision-making process for audiologists treating infants with hearing loss. By providing additional brain activity information alongside standard audiological test results, the study seeks to improve early intervention strategies for affected infants. A pool of experienced audiologists will evaluate the fNIRS results to make more informed management decisions at critical points in the hearing care pathway. The trial will also assess the comfort and acceptability of the fNIRS testing experience for parents and caregivers.
Why it matters
Potential benefit: If successful, this approach could lead to faster and more effective interventions for infants with hearing loss, significantly improving their speech and language development.
How similar studies have gone: While the use of fNIRS in audiology is relatively novel, similar studies in other fields have shown promising results in enhancing diagnostic capabilities.
Who can join: the full rules
Show full inclusion / exclusion criteria
The above eligibility applies to the participating audiologists who are in the experimental and control arms of the study Audiologist Inclusion Criteria: * Is a qualified audiologist who meets the criteria for membership of Audiology Australia. * Has at least 1 year of experience in paediatric diagnostic, hearing aid or cochlear implant audiology service provision in Australia. * Provides a signed and dated informed consent form. Audiologist Exclusion criteria (only for a specific infant test result): * Is the managing audiologist for the infant who's results are being provided. Infants are also recruited into the study to have an fNIRS assessment performed. They do not participate further after the fNIRS test. Infant Inclusion criteria: * Between the ages of 1 and 24 months at the time of fNIRS testing. * Has permanent hearing loss in one or both ears as determined by audiological diagnostic testing. * Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Infant Exclusion Criteria: * There are no exclusion criteria other than not meeting the inclusion criteria.
Where it's running
-
Bionics Institute
Fitzroy, Victoria, Australia Recruiting -
The Royal Children's Hospital
Parkville, Victoria, Australia Recruiting -
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia Not yet recruiting -
Barwon Health
Geelong, Victoria, Australia Not yet recruiting -
Hearing Australia
Moonee Ponds, Victoria, Australia Not yet recruiting
Study contacts
- Principal investigator: Professor Colette McKay — The Bionics Institute of Australia
- Study coordinator: Professor Colette McKay
- Email: cmckay@bionicsinstitute.org
- Phone: +61 3 9667 7541
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.