N/A N=11 Device Feasibility

EarGenie: Assessment of a Minimum Viable Product

Hearing Impaired Children

Bottom Line

View on ClinicalTrials.gov: NCT05962814 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Prevalence of Significant fNIRS Detection and Discrimination Responses — 4; 6; 1; 9 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EarGenie MVP test (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: The Bionics Institute of Australia
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Prevalence of Significant fNIRS Detection and Discrimination Responses	4; 6; 1; 9; 10; 0	—
SECONDARY Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	0; 10; 10; 0; 0; 10	—

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.

Eligibility Criteria

Inclusion Criteria

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 Criteria

There are no exclusion criteria other than not meeting the inclusion criteria.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05962814). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.