EarGenie MVP Performance Evaluation

NCT06406088 | Terminated

• 1 other identifier: 105500
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Hearing Impaired Children

Keywords

fNIRS

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

EarGenie MVP

EXPERIMENTAL

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

Device: EarGenie MVP test

Interventions

EarGenie MVP test DEVICE

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.

EarGenie MVP

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants with skin conditions such as cradle cap, eczema, or other skin conditions on the head will be excluded.

Sponsors & Collaborators

• The Bionics Institute of Australia: lead

Study Sites (1)

Bionics Institute

Fitzroy, Victoria, 3065, Australia

Location

Study Officials

• Colette McKay, PhD

  The Bionics Institute of Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leader, Translational Hearing Research and Principal Scientist

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 9, 2024
• Study Start: August 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)