Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)

August 14, 2025 updated by: Colette McKay, The Bionics Institute of Australia

The goal of this clinical trial is to find out whether hearing test results using functional near-infrared spectroscopy (fNIRS) will help to fast-track early intervention for infants born with a hearing loss. fNIRS is a method of imaging brain activity using light. The main questions are:

  1. Can audiologists make more confident decisions about the optimal interventions at different critical points in the hearing care pathway when they are given additional fNIRS information compared to when they have standard audiology test results alone?
  2. Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Universal newborn hearing screening (UNHS) has reduced the age of diagnosis of permanent childhood hearing loss from several years down to several weeks. While this is highly desirable, the early diagnosis raises challenges for the audiologists who manage these infants. The challenges are due to a lack of relevant audiological information, particularly about an infant's ability to discriminate between different speech sounds, and, for infants with Auditory Neuropathy, their degree of hearing impairment, which is required to make key management decisions. The missing information causes intervention delays at several time-critical points along the standard hearing care pathway that could seriously affect speech and language development for the infant, with life-long social, educational and employment consequences. The goal of this trial is to assess whether the addition of audiological information provided by fNIRS assessments can address these challenges for audiologists who care for infants with different types of hearing loss and at the different critical decision points in the care pathway.

A pool of at least 40 experienced audiologists will be recruited to participate in the study. In addition, infants with different types and degree of hearing loss, and at the different critical points in their care pathway will be recruited to provide fNIRS test results. For each infant, a group of ten paediatric audiologists will be randomly selected from the large pool and will be provided with anonymised audiological test results. Each audiologist will receive the current test results of the infant twice, once with, and once without the additional fNIRS test results, with 2 months between. Half (5 randomly selected) will receive the standard plus additional fNIRS test results before the standard-alone results and the other half in reverse order. The audiologists will be asked, via a questionnaire, to make clinical decisions relevant to the infant's point in the hearing care pathway and to rate their confidence in their decisions on a sliding scale.

Infants will be recruited for fNIRS tests at each of four points in the care pathway (after diagnosis, after first hearing aid provision, when optimal hearing aid program is established, and after cochlear implantation. The critical management decisions at these four points are, respectively: Is a hearing aid needed?; Is the hearing aid optimally programmed for the infant?; Would the infant be better off with a cochlear implant instead of their hearing aid?; and Is the cochlear implant programmed optimally for the infant?

Parents/guardians will also be surveyed about their experience with the fNIRS test.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • Bionics Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Prof Colette McKay
        • Sub-Investigator:
          • Dr Julia Wunderlich
        • Sub-Investigator:
          • Dr Darren Mao
        • Sub-Investigator:
          • Dr Gautam Balasubramanian
      • Geelong, Victoria, Australia, 3220
      • Moonee Ponds, Victoria, Australia, 3039
      • Parkville, Victoria, Australia, 3052
        • Recruiting
        • The Royal Children's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

The above eligibility applies to the participating audiologists who are in the experimental and control arms of the study

Audiologist Inclusion Criteria:

  • Is a qualified audiologist who meets the criteria for membership of Audiology Australia.
  • Has at least 1 year of experience in paediatric diagnostic, hearing aid or cochlear implant audiology service provision in Australia.
  • Provides a signed and dated informed consent form.

Audiologist Exclusion criteria (only for a specific infant test result):

  • Is the managing audiologist for the infant who's results are being provided.

Infants are also recruited into the study to have an fNIRS assessment performed. They do not participate further after the fNIRS test.

Infant Inclusion criteria:

  • Between the ages of 1 and 24 months at the time of fNIRS testing.
  • Has permanent hearing loss in one or both ears as determined by audiological diagnostic testing.
  • Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Infant Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Provision of standard audiological + fNIRS test results

The treatment arm involves the provision of additional fNIRS sound detection and speech discrimination test results to the audiologists, in addition to standard audiology information. Standard information includes:

  1. At diagnosis: unaided Auditory Brainstem Response results;
  2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;
  3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);
  4. After initial cochlear implant programming: behavioural observations.
Other: Provision of standard audiological + fNIRS test results
Infants with hearing loss will be tested using functional near-infrared spectroscopy (fNIRS) and a patented analysis algorithm to measure sound detection and discrimination. Their standard audiological test results will also be collected from their audiology service provider/s. Both sets of test results will be given to the participating audiologists in the experimental arm.
Active Comparator: Provision of standard audiological test results only

The standard audiology information available to the audiologists includes:

  1. At diagnosis: unaided Auditory Brainstem Response results;
  2. After initial hearing aid provision: as a) above plus aided Cortical Evoked Potentials;
  3. After hearing aid program is adjusted to satisfaction: as b) above plus parent observational report, PEACH (2);
  4. After initial cochlear implant programming: behavioural observations.
Other: Provision of standard audiological test results only
The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in confidence of audiological clinical management decisions when fNIRS hearing test results are included with standard audiological information compared to when using standard information alone
Time Frame: Between each infant's completed fNIRS testing session and 2 months after
The questionnaire responses that the participating audiologists provide will measure their confidence in making the appropriate next decision for the infant using a sliding scale (0 (no confidence) to 100 (high confidence)). The data from the sliding scale responses for the same audiologist/infant will be subtracted (confidence with fNIRS minus confidence without fNIRS) to obtain the raw data for analysis.
Between each infant's completed fNIRS testing session and 2 months after

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results
Time Frame: Within 2 weeks after their child's fNIRS testing session
The results of a parent questionnaire developed by the Advisory Committee (which includes parent members) will be qualitatively evaluated to determine if the fNIRS test process was acceptable, and the test results were perceived as useful. The results will also indicate whether there are aspects of the test process that could be improved in future to make it more acceptable to parents.
Within 2 weeks after their child's fNIRS testing session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Bionics Institute of Australia

Investigators

  • Principal Investigator: Professor Colette McKay, The Bionics Institute of Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2023

Primary Completion (Estimated)

April 28, 2028

Study Completion (Estimated)

April 28, 2028

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90457

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Beginning 1 month following analysis and article publication, the following data will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept Bionics Institute's conditions for access:

  • Raw anonymized confidence rating scores linked to the questionnaire question, infant subgroup (type and degree of hearing loss categories), and point in clinical care pathway.
  • study protocol and statistical analysis plan if not already clear in the publication

IPD Sharing Time Frame

Data, study protocol, and statistical analysis plan will be available from one month following trial analysis and article publication, for a period of 10 years.

IPD Sharing Access Criteria

Data can only be accessed if the researchers are from a recognized research institution, the proposed use of the data has been ethically reviewed and approved by an independent committee, and the researchers accept Bionics Institute's conditions for access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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