EarGenie MVP Performance Evaluation

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 15, 2024

Primary Completion Date

December 15, 2025

Study Completion Date

December 15, 2025

Conditions
Hearing Impaired Children
Interventions
DEVICE

EarGenie MVP test

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.

Trial Locations (1)

3065

RECRUITING

Bionics Institute, Fitzroy

All Listed Sponsors
lead

The Bionics Institute of Australia

OTHER