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EarGenie MVP Performance Evaluation
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).
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 1 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-08-15
Primary completion: 2025-12-15
Study completion finish: 2025-12-15
Study type
DIAGNOSTIC
Phase
NA
Trial ID
NCT06406088
Intervention or treatment
DEVICE: EarGenie MVP test
Conditions
- • Hearing Impaired Children
Find a site
Closest Location:
Bionics Institute
Research sites nearby
Select from list below to view details:
Bionics Institute
East Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: EarGenie MVP
| DEVICE: EarGenie MVP test
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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 \[1- the proportion of infants whose test result for a control condition (silence) showed a (false) detection\]. | 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. | Up to 18 months |
Secondary outcome
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