EarGenie: Assessment of a Minimum Viable Product - Trial NCT05962814
Access comprehensive clinical trial information for NCT05962814 through Pure Global AI's free database. This phase not specified trial is sponsored by The Bionics Institute of Australia and is currently Not yet recruiting. The study focuses on Hearing Impaired Children. Target enrollment is 10 participants.
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Study Focus
Sponsor & Location
The Bionics Institute of Australia
Timeline & Enrollment
N/A
Aug 14, 2023
Nov 30, 2023
Primary Outcome
Prevalence of significant fNIRS detection and discrimination responses
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05962814
Device Trial