Pure Global

EarGenie MVP Performance Evaluation - Trial NCT06406088

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.

Free Database
Powered by Pure Global AI
840K+ Trials
Device Trial
NCT06406088
Not yet recruiting
Device Trial
device
Trial Details
ClinicalTrials.gov โ€ข NCT06406088
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
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

Study Focus

Hearing Impaired Children

EarGenie MVP test

Interventional

device

Sponsor & Location

The Bionics Institute of Australia

East Melbourne, Australia

Timeline & Enrollment

N/A

Jun 15, 2024

Dec 15, 2025

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, unspecified
Other hearing loss
Other specified hearing loss
Family history of deafness and hearing loss
Congenital malformations of ear causing impairment of hearing

Data Source

ClinicalTrials.gov

NCT06406088

Device Trial