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EarGenie: Assessment of a Minimum Viable Product

NCT05962814 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-02-06

Study results available
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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.

Conditions

  • Hearing Impaired Children

Interventions

DEVICE

EarGenie MVP test

The EarGenie test consists of placing the EarGenie headgear on the infant and running the fNIRS tests via the user interface. Blocks of speech sounds are presented to the infant via earphones or via speaker, and the EarGenie MVP measures changes in the blood oxygenation. Automatic analyses are run to determine whether the infant heard the sounds or discriminated between them. The infant will be in a natural sleep when the fNIRS test is run. Prior to the test, standard audiometric procedures (otoscopy and tympanometry) will confirm normal middle ear function.

Sponsors & Collaborators

  • The Bionics Institute of Australia

    lead OTHER

Principal Investigators

  • Colette M McKay, PhD · The Bionics Institute of Australia

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-14
Primary Completion
2024-02-26
Completion
2024-02-26

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05962814 on ClinicalTrials.gov