CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
EarGenie MVP testdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05962814
NCT05962814N/ACompleted
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EarGenie: Assessment of a Minimum Viable Product

The Bionics Institute of Australia·interventional·Posted Jul 27, 2023·Updated Feb 6, 2025

In Brief

A clinical study evaluating EarGenie MVP test for Hearing Impaired Children. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to evaluate safety and preliminary efficacy of a novel device (EarGenie MVP) to assess hearing function in infants, using a small number of infants with normal hearing. The main questions it aims to answer are: * Is our device safe? * Does the device provide preliminary results consistent with previous results from a commercial functional Near Infrared Spectroscopy (fNIRS) research device? Participants will attend one test session and have their hearing assessed with the EarGenie MVP device.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHearing Impaired Children
CountriesAustralia
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedJul 27, 2023
Enrollment StartAug 14, 2023
Primary CompletionFeb 26, 2024
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 2.9 years ago

Interventions

EarGenie MVP testdevice

The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests 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. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.