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EarGenie MVP Performance Evaluation
Sponsor: The Bionics Institute of Australia
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).
Official title: EarGenie Minimum Viable Product (MVP) Performance Evaluation: Sensitivity and Specificity of a Test of Sound Detection and Discrimination Using Functional Near-infrared Spectroscopy (fNIRS) in a Single Group Trial of Normal Hearing Infants
Key Details
Gender
All
Age Range
1 Month - 24 Months
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-08-15
Completion Date
2025-12-15
Last Updated
2025-01-08
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (1)
Bionics Institute
Fitzroy, Victoria, Australia