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 range1 Month – 24 Months

SexALL

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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.

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