TerminatedNot Applicable

EarGenie MVP Performance Evaluation

Stopped: Funding ceased, as Principal Investigator is no longer based at the Bionics Institute (Sponsor).

Australia10 participantsStarted 2024-08-15

Plain-language 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 levels (detection) and speech sound contrasts (discrimination).

Who can participate

Age range

1 Month – 24 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.

Timeframe: Up to 18 months

Performance of the EarGenie test of speech discrimination for a range of speech sound contrasts in normal-hearing infants

Timeframe: Up to 18 months

Trial details

NCT IDNCT06406088

SponsorThe Bionics Institute of Australia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Hearing Impaired Children trials