Status:
COMPLETED
EarGenie: Assessment of a Minimum Viable Product
Lead Sponsor:
The Bionics Institute of Australia
Conditions:
Hearing Impaired Children
Eligibility:
All Genders
1-24 years
Phase:
NA
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 heari...
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 infant's brain res...
Eligibility Criteria
Inclusion
- Is between the ages of 1 and 24 months at the time of fNIRS testing.
- Has no known hearing loss
- Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.
Exclusion
- There are no exclusion criteria other than not meeting the inclusion criteria.
Key Trial Info
Start Date :
August 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05962814
Start Date
August 14 2023
End Date
February 26 2024
Last Update
February 6 2025
Active Locations (1)
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1
Bionics Institute
East Melbourne, Victoria, Australia, 3002