N/A
Completed N=11
EarGenie: Assessment of a Minimum Viable Product
Hearing Impaired Children
Source: ClinicalTrials.gov NCT05962814 ↗
Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Prevalence of Significant fNIRS Detection and Discrimination Responses — 4; 6; 1; 9 Participants
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.
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 | — |
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.
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. Informational only — not medical advice.