EarGenie: Assessment of a Minimum Viable Product

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

This is a first-in-human study to evaluate safety and preliminary efficacy of our prototype hearing assessment system (EarGenie MVP). EarGenie MVP uses fNIRS technology to assess an infant's brain response to hearing speech sounds, or discriminating between different speech sounds. It includes software to automatically run analysis in real time, and has a user interface allowing clinicians to operate the tests and receive result reports. The test methods and analysis software have been developed using our commercial fNIRS research system, but the EarGenie MVP has been designed for easy use in paediatric audiology clinics. 10 infants with normal hearing will be recruited for the study, and undergo one test session each with the EarGenie MVP. Safety data will be documented and the results of the tests examined to see if they are consistent with the results expected from our experience using the commercial device in 36 infants with normal hearing. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05962814
Study type	Interventional
Source	The Bionics Institute of Australia
Contact	Colette M McKay, PhD
Phone	+61 408698202
Email	cmckay@bionicsinstitute.org
Status	Not yet recruiting
Phase	N/A
Start date	August 14, 2023
Completion date	November 30, 2023

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