EarGenie MVP Performance Evaluation

Not Applicable

Recruiting

• Conditions: Hearing Impaired Children
• Interventions: Device: EarGenie MVP test

• Registration Number: NCT06406088
• Lead Sponsor: The Bionics Institute of Australia

Brief 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).

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 Timeline

• Study First Submitted: 2024-05-01
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-09
• Study Start: 2024-08-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EarGenie MVP	EarGenie MVP test	Infants who have a test completed with EarGenie MVP in a single test session

Primary Outcome Measures

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

Trial Locations

Locations (1)

Bionics Institute; 🇦🇺 Fitzroy, Victoria, Australia