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NCT05962814

EarGenie: Assessment of a Minimum Viable Product

The Bionics Institute of Australia·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hearing Impaired Children
Drug/Device/Intervention
EarGenie MVP test
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
The Bionics Institute of Australia
Timeline & enrollment
Phase
N/A
Start date
Aug 14, 2023
End date
Nov 30, 2023
Enrollment
10 participants
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
Hearing loss, unspecifiedOther hearing lossOther specified hearing lossFamily history of deafness and hearing lossCongenital malformations of ear causing impairment of hearing
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05962814
Type
Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.