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NCT06406088

EarGenie MVP Performance Evaluation

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
The Bionics Institute of Australia·ClinicalTrials.gov·device·Device trialNot yet recruiting
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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
Location
East Melbourne, Australia
Timeline & enrollment
Phase
N/A
Start date
Jun 15, 2024
End date
Dec 15, 2025
Enrollment
50 participants
Primary outcome

Performance of the EarGenie test of sound detection for a range of sound levels in normal-hearing infants.,Performance of the EarGenie test of speech discrimination for a range of speech sound contrasts in normal-hearing infants

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).

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
NCT06406088
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06406088 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 50 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.