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Baby brain scan could revolutionize hearing tests

NCT ID NCT06406088

Diagnosis Sponsor: The Bionics Institute of Australia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a device called EarGenie that uses light to measure brain activity in babies while they listen to sounds. The goal was to see if it could accurately detect whether infants can hear and tell sounds apart. The trial included 10 normal-hearing babies aged 1-24 months, but was terminated early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EarGenie MVP test (device using fNIRS to measure brain responses to sound)
What this could lead to
If successful, this could lead to a simple, non-invasive hearing test for babies that doesn't require them to respond actively.
What could go wrong
This was a small, early-stage trial that was terminated, so results are limited. The device may not be accurate enough for real-world use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Aug 2024

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 24 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Each infant must meet all of the following criteria to be enrolled in this trial: * Is between the ages of 1 and 24 months at the time of fNIRS testing. * Has no known hearing loss, having either passed newborn hearing screening or diagnostic audiological assessment. * Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Exclusion Criteria: * Infants with skin conditions such as cradle cap, eczema, or other skin conditions on the head will be excluded. There are no additional exclusion criteria other than not meeting the inclusion criteria.

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Conditions

The condition(s) this trial relates to.

hearing loss disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing impaired children

Contacts and locations

Locations

  • Bionics Institute

    Fitzroy, Victoria, 3065, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.