Hearing Impaired ChildrenNCT06406088
EarGenie MVP Performance Evaluation
A study testing EarGenie MVP test in people with Hearing Impaired Children, run by The Bionics Institute of Australia at 1 site in Australia.
Trial summary
This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants. The EarGenie MVP tests for detection and discrimination of sounds will be administered, and the sensitivity and specificity of the tests will be estimated for a range of sound… 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
- 10 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Aug 2024to 31 Dec 2025
- Phase
- Interventional
- 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 month to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EarGenie Minimum Viable Product (MVP) Performance Evaluation: Sensitivity and Specificity of a Test of Sound Detection and Discrimination Using Functional Near-infrared Spectroscopy (fNIRS) in a Single Group Trial of Normal Hearing Infants
This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants. The EarGenie MVP tests for detection and discrimination of sounds will be administered, and the sensitivity and specificity of the tests will be estimated for a range of sound levels (detection) and speech sound contrasts (discrimination).
Read the detailed description
Procedures:
All procedures will be carried out in a single test session.
Determination of infant eligibility will be undertaken by confirming that the infant has passed hearing screening or diagnostic audiological assessment and is under the age of 2 years.
Before completing the fNIRS tests, the infant will undergo otoscopy and tympanometry to exclude possible temporary conductive hearing loss associated with abnormal tympanometric results. These are standard audiological procedures. If the infant has abnormal tympanometric results in both ears on the day, the test session will be rescheduled. The parent/guardian will be advised of the finding and its possible consequences (possible conductive hearing loss, possible progression to acute otitis media) and advised to seek medical advice should the infant show signs of illness or if hearing loss is suspected.
All assessments in the fNIRS test session will be undertaken by qualified paediatric audiologists who are trained in the fNIRS procedures.
For the fNIRS tests, the infant will be asleep or in a quietly entertained response state.
After the headgear is placed on the infant's head, an optode calibration procedure is undertaken to ensure the equipment is ready. During the actual test, blocks of speech sounds lasting 5.4 seconds will be played to the infant either via tubephone or via speakers. During and after the test session, the infant will be monitored for any signs of discomfort or distress. Testing will discontinue if the infant is not either asleep or in a quiet response state.
For the detection test, a single speech sound "BA" will be presented at several levels (35, 50, and 65 dBSPL), and the test blocks will include "no sound" blocks to allow estimates of false positive results.
For the discrimination test, three different speech contrasts will be presented ("BA/TEA", "BA/BEE", and "BA/GA") at 65 dB SPL. The test will also include blocks of "BA/BA" to allow estimates of false positive rates.
For each infant, the sound levels at which "BA" evoked a statistically significant response will be recorded, and/or the speech contrasts which evoked a significant discrimination response will be recorded. Each infant will either have a detection test or a discrimination test, or both if their response state allows. At least 50 full detection and 50 full discrimination test results for estimating sensitivity and specificity outcome measures will be obtained.
- Conditions
- Hearing Impaired Children
- Being tested
- EarGenie MVP test
- Keywords
- fNIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EarGenie MVP testDevice
The EarGenie MVP test consists of placing the EarGenie headgear containing light emitting diodes (LEDs) and light detectors on the infant and running the fNIRS tests of sound detection or sound discrimination 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 in temporal and prefrontal regions of the cortex. Automatic analyses are run to determine whether the infant heard the sounds (at levels 35, 50, and 65 dBSPL) or discriminated between two sounds (Ba/Tea, Ba/Bee, or Ba/Ga). The infant will be in a natural sleep or quiet awake state when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.
| Study group | Role | What they receive |
|---|---|---|
| EarGenie MVP | 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.
Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.
The primary outcome 1 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the detection test for three audible sound levels (65, 50, 35 dBSPL) within the comfortable loudness range.
Sensitivity for the detection test will be estimated as the proportion of infants for whom the test result showed a positive detection and specificity will be estimated as [1- the proportion of infants whose test result for a control condition (silence) showed a (false) detection].
Measured: Up to 18 months
Performance of the EarGenie test of speech discrimination for a range of speech sound contrasts in normal-hearing infants
The primary outcome 2 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the discrimination test for three difference speech sound contrasts differing in difficulty (BA/TEA, BA/BEE, and BA/GA), all presented at 65 dB SPL.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start15 Aug 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Why it stopped: Funding ceased, as Principal Investigator is no longer based at the Bionics Institute (Sponsor).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group of infants without hearing impairment will be recruited so that the performance of the two EarGenie MVP tests of speech sound detection and discrimination can be estimated.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Bionics Institute of Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colette McKay, The Bionics Institute of Australia
- Investigators
- Colette McKay, PhD, Principal investigator, The Bionics Institute of Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406088
- Sponsor's protocol ID
- 105500
- Status last verified
- Apr 2026
- First submitted
- 1 May 2024
- Last updated
- 27 Apr 2026
- 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 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EarGenie Minimum Viable Product (MVP) Performance Evaluation: Sensitivity and Specificity of a Test of Sound Detection and Discrimination Using Functional Near-infrared Spectroscopy (fNIRS) in a Single Group Trial of Normal Hearing Infants
- ClinicalTrials.gov ID
- NCT06406088
- Acronym / sponsor ID
- 105500
- Conditions
- Hearing Impaired Children
- Keywords
- fNIRS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding ceased, as Principal Investigator is no longer based at the Bionics Institute (Sponsor).
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Bionics Institute of AustraliaUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 9 May 2024 (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.
This is a single-group clinical trial to evaluate the performance of the EarGenie minimum viable product (MVP) in normal hearing infants. The EarGenie MVP tests for detection and discrimination of sounds will be administered, and the sensitivity and specificity of the tests will be estimated for a range of sound levels (detection) and speech sound contrasts (discrimination).
Detailed description
Procedures:
All procedures will be carried out in a single test session.
Determination of infant eligibility will be undertaken by confirming that the infant has passed hearing screening or diagnostic audiological assessment and is under the age of 2 years.
Before completing the fNIRS tests, the infant will undergo otoscopy and tympanometry to exclude possible temporary conductive hearing loss associated with abnormal tympanometric results. These are standard audiological procedures. If the infant has abnormal tympanometric results in both ears on the day, the test session will be rescheduled. The parent/guardian will be advised of the finding and its possible consequences (possible conductive hearing loss, possible progression to acute otitis media) and advised to seek medical advice should the infant show signs of illness or if hearing loss is suspected.
All assessments in the fNIRS test session will be undertaken by qualified paediatric audiologists who are trained in the fNIRS procedures.
For the fNIRS tests, the infant will be asleep or in a quietly entertained response state.
After the headgear is placed on the infant's head, an optode calibration procedure is undertaken to ensure the equipment is ready. During the actual test, blocks of speech sounds lasting 5.4 seconds will be played to the infant either via tubephone or via speakers. During and after the test session, the infant will be monitored for any signs of discomfort or distress. Testing will discontinue if the infant is not either asleep or in a quiet response state.
For the detection test, a single speech sound "BA" will be presented at several levels (35, 50, and 65 dBSPL), and the test blocks will include "no sound" blocks to allow estimates of false positive results.
For the discrimination test, three different speech contrasts will be presented ("BA/TEA", "BA/BEE", and "BA/GA") at 65 dB SPL. The test will also include blocks of "BA/BA" to allow estimates of false positive rates.
For each infant, the sound levels at which "BA" evoked a statistically significant response will be recorded, and/or the speech contrasts which evoked a significant discrimination response will be recorded. Each infant will either have a detection test or a discrimination test, or both if their response state allows. At least 50 full detection and 50 full discrimination test results for estimating sensitivity and specificity outcome measures will be obtained.
Study design
- Primary purpose
- Diagnosis
- 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 the performance of the two EarGenie MVP tests of speech sound detection and discrimination can be estimated.
| Arm | Type | Receives |
|---|---|---|
| EarGenie MVP | 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 (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 MVP test consists of placing the EarGenie headgear containing light emitting diodes (LEDs) and light detectors on the infant and running the fNIRS tests of sound detection or sound discrimination 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 in temporal and prefrontal regions of the cortex. Automatic analyses are run to determine whether the infant heard the sounds (at levels 35, 50, and 65 dBSPL) or discriminated between two sounds (Ba/Tea, Ba/Bee, or Ba/Ga). The infant will be in a natural sleep or quiet awake state when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function. | Device | EarGenie MVP |
Primary outcome
Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.
Time frame: Up to 18 months
The primary outcome 1 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the detection test for three audible sound levels (65, 50, 35 dBSPL) within the comfortable loudness range. Sensitivity for the detection test will be estimated as the proportion of infants for whom the test result showed a positive detection and specificity will be estimated as [1- the proportion of infants whose test result for a control condition (silence) showed a (false) detection].
Performance of the EarGenie test of speech discrimination for a range of speech sound contrasts in normal-hearing infants
Time frame: Up to 18 months
The primary outcome 2 is a set of test results that allow the sensitivity and specificity of the test to be estimated within +/-5% accuracy. Outcome measures (sensitivity and specificity) will be calculated for the discrimination test for three difference speech sound contrasts differing in difficulty (BA/TEA, BA/BEE, and BA/GA), all presented at 65 dB SPL.
Results and safety
The study was stopped early (reason given: Funding ceased, as Principal Investigator is no longer based at the Bionics Institute (Sponsor).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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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 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Apr 2026. 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 was stopped early (reason given: Funding ceased, as Principal Investigator is no longer based at the Bionics Institute (Sponsor).). Results are not available in the source record.
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?
Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants. (time frame: Up to 18 months). The study lists 2 primary outcomes in all. 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 27 Apr 2026.