Adults 1 Month to 24 Months, any sex, with Hearing Impaired Children. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Prevalence of Significant fNIRS Detection and Discrimination ResponsesPrimary· Each infant has one test session, lasting up to to hours. Outcome measures are determined after the last infant has been tested.
Evidence of device feasibility will be obtained by comparing the test results obtained using EarGenie MVP to our existing test results for a larger number of infants obtained with a commercial device NIRx (McKay et al. 2023. "A Reliable, Accurate, and Clinic-friendly Objective Test of Speech Sound Detection and Discrimination in Sleeping Infants." PsyArXiv. June 20. doi:10.31234/osf.io/fbwcm).
For each infant, the presence of a significant response is determined by the incorporated automatic analysis software, and further visually supported for the tester by checking that the shape of the res
significant detection response to BA at 65 dB SPL
Group
Value
95% CI
fNIRS
4
fNIRS
6
significant discrimination response to BA/GA contrast
Group
Value
95% CI
fNIRS
1
fNIRS
9
Response morphologies consitent with morphologies of research device
Group
Value
95% CI
fNIRS
10
fNIRS
0
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]Secondary· Adverse effects are noted during, and for 24 hours following the single test session of the infant. Incidence of events is calculated after the last infant is tested.
Safety assessment will be undertaken as follows. Any adverse event (as defined using standard definitions) will be documented in each infant's case report, and reported using standard required procedures. Each infant's case report will also include details of any minor non-reportable occurrences only relevant to comfort of use such as discomfort signs in the infant, or any temporary visual skin marks left by the headgear after the test.
If any major adverse effect occurs, the trial will be stopped until the such time as the issue is resolved.
Adverse events
Group
Value
95% CI
fNIRS
0
fNIRS
10
no impression marks on skin, or impression marks that resolved within 3 hours
Group
Value
95% CI
fNIRS
10
fNIRS
0
signs of distress during test such as crying
Group
Value
95% CI
fNIRS
0
fNIRS
10
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by The Bionics Institute of Australia
Last refreshed: 6 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05962814.