Ignite Creation Date:
2024-05-06 @ 7:17 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05962814
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2023-07-10
Brief Title:
EarGenie Assessment of a Minimum Viable Product
Sponsor:
The Bionics Institute of Australia
Organization:
The Bionics Institute of Australia
Study Overview
Official Title:
EarGenie Assessment of a Minimum Viable Product
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 infants 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None