Hearing Impaired ChildrenNCT05962814

EarGenie: Assessment of a Minimum Viable Product

A study testing EarGenie MVP test in people with Hearing Impaired Children, run by The Bionics Institute of Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to evaluate safety and preliminary efficacy of a novel device (EarGenie MVP) to assess hearing function in infants, using a small number of infants with normal hearing. Read more about this study

Who is it for?: Ages 1 month to 24 monthsHealthy volunteers can take part
Conditions the study is for: Hearing Impaired Children
What is being tested?: EarGenie MVP test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteAustralia
Study dates: 14 Aug 2023to 26 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 month to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Is between the ages of 1 and 24 months at the time of fNIRS testing.
Has no known hearing loss
Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Who cannot join

There are no exclusion criteria other than not meeting the inclusion criteria.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Bionics Institute
East Melbourne, Victoria, 3002

Other trials in Australia

About this study

Is our device safe?
Does the device provide preliminary results consistent with previous results from a commercial functional Near Infrared Spectroscopy (fNIRS) research device?

Participants will attend one test session and have their hearing assessed with the EarGenie MVP device.

Read the detailed description

This is a first-in-human study to evaluate safety and preliminary efficacy of our prototype hearing assessment system (EarGenie MVP). EarGenie MVP uses fNIRS technology to assess an infant's brain response to hearing speech sounds, or discriminating between different speech sounds. It includes software to automatically run analysis in real time, and has a user interface allowing clinicians to operate the tests and receive result reports. The test methods and analysis software have been developed using our commercial fNIRS research system, but the EarGenie MVP has been designed for easy use in paediatric audiology clinics.

10 infants with normal hearing will be recruited for the study, and undergo one test session each with the EarGenie MVP. Safety data will be documented and the results of the tests examined to see if they are consistent with the results expected from our experience using the commercial device in 36 infants with normal hearing.

Conditions: Hearing Impaired Children
Being tested: EarGenie MVP test
Keywords: fNIRS, Early intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EarGenie MVP testDevice
The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.

Study groups in NCT05962814
Study group	Role	What they receive
fNIRS	Experimental	Infants who have a test completed with EarGenie MVP in a single test session Receives: Device: EarGenie MVP test

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of Significant fNIRS Detection and Discrimination Responses
Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. "A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants." PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm).
For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for "Ba" versus "Ga".
Measured: Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.

Secondary outcomes (1)

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety assessment will be undertaken as follows. Any adverse event (as defined using standard definitions) will be documented in each infant's case report, and reported using standard required procedures. Each infant's case report will also include details of any minor non-reportable occurrences only relevant to comfort of use such as discomfort signs in the infant, or any temporary visual skin marks left by the headgear after the test.
If any major adverse effect occurs, the trial will be stopped until the such time as the issue is resolved.
Measured: Adverse effects are noted during, and for 24 hours following the single test session of the infant. Incidence of events is calculated after the last infant is tested.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Aug 202326 Feb 2024

First posted27 Jul 2023
Study start14 Aug 2023
Primary completion26 Feb 2024
Study completion26 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hearing Impaired ChildrenStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Model description: A single group of infants without hearing impairment will be recruited so that safety and preliminary efficacy can be determined.
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05962814
Sponsor's protocol ID: 98058
Status last verified: Feb 2025
First submitted: 10 Jul 2023
Last updated: 6 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
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Recruiting
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All Hearing Impaired Children trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EarGenie: Assessment of a Minimum Viable Product
ClinicalTrials.gov ID: NCT05962814
Acronym / sponsor ID: 98058
Conditions: Hearing Impaired Children
Keywords: fNIRS, Early intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: The Bionics Institute of AustraliaUniversity, hospital or other
Study start: 14 Aug 2023 (actual)
Primary completion: 26 Feb 2024 (actual)
Study completion: 26 Feb 2024 (actual)
First posted: 27 Jul 2023 (actual)
Results: Posted 6 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Is our device safe?
Does the device provide preliminary results consistent with previous results from a commercial functional Near Infrared Spectroscopy (fNIRS) research device?

Participants will attend one test session and have their hearing assessed with the EarGenie MVP device.

Detailed description

Study design

Primary purpose: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: A single group of infants without hearing impairment will be recruited so that safety and preliminary efficacy can be determined.

Arm	Type	Receives
fNIRS	Experimental	Device: EarGenie MVP testInfants who have a test completed with EarGenie MVP in a single test session

Who may qualify

Ages: 1 month to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Is between the ages of 1 and 24 months at the time of fNIRS testing.
Has no known hearing loss
Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Key exclusion criteria (1 listed)

There are no exclusion criteria other than not meeting the inclusion criteria.

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
EarGenie MVP testThe EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.	Device	fNIRS

Primary outcome

Prevalence of Significant fNIRS Detection and Discrimination Responses
Time frame: Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.
Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. "A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants." PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm). For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the response waveform is consistent with those found in the previous data set. We will consider the feasibility as confirmed if not more than 1(/10) infants (or 10%) have an absent detection response at 65 dB SPL, and not more than 3 (/10) babies (or 30%) show an absent discrimination response for "Ba" versus "Ga".

1 secondary outcome

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Adverse effects are noted during, and for 24 hours following the single test session of the infant. Incidence of events is calculated after the last infant is tested.

Results and safety

Results posted to the registry on 6 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
fNIRS	11	10

Primary outcome: Prevalence of Significant fNIRS Detection and Discrimination Responses

Time frame: Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.. Count of participants. Unit: Participants

Measure	fNIRS n = 10
significant detection response to BA at 65 dB SPL: with	4
significant detection response to BA at 65 dB SPL: without	6
significant discrimination response to BA/GA contrast: with	1
significant discrimination response to BA/GA contrast: without	9
Response morphologies consitent with morphologies of research device: with	10
Response morphologies consitent with morphologies of research device: without	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Data were collected over the duration of the trial, and for each infant during the test and the 24 hours post the test. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
fNIRS	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Hearing Impaired Children

Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
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RecruitingObservational study
Audiological Rehabilitation of Children With Unilateral Hearing Loss
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Not yet recruiting
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Recruiting
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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.

Colette M McKay, PhD principal investigator

The Bionics Institute of Australia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EarGenie MVP test in people with Hearing Impaired Children, run by The Bionics Institute of Australia 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 1 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 6 Feb 2025. 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?

Yes. Results are posted in the registry (first posted 6 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Prevalence of Significant fNIRS Detection and Discrimination Responses (time frame: Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05962814.

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 6 Feb 2025.