Hearing ImpairmentNCT05847426
Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
A study testing Provision of standard audiological + fNIRS test results and Provision of standard audiological test results only in people with Hearing Impairment, run by The Bionics Institute of Australia at 5 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 24 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Impairment
- What is being tested?
- Provision of standard audiological + fNIRS test results and Provision of standard audiological test results only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesAustralia
- Study dates
- 2 May 2023to 28 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Not yet recruiting
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002
Jaime Leigh, +61399298624, jaime.leigh@eyeandear.org.au
Rebecca Farrell, +61399298624, rebecca.farrell@eyeandear.org.au
- Recruiting
Bionics Institute
Fitzroy, Victoria, 3065
Prof Colette McKay, +61 3 9667 7541, cmckay@bionicsinstitute.org
Dr Julia Wunderlich, +61 3 9667 7500, hearingstudy@bionicsinstitute.org
- Not yet recruiting
Barwon Health
Geelong, Victoria, 3220
Rachael Hyder, +61342150873, rachael.hyder@barwonhealth.org.au
- Not yet recruiting
Hearing Australia
Moonee Ponds, Victoria, 3039
Lauren Burns, +61383259000, lauren.burns@hearing.com.au
- Recruiting
The Royal Children's Hospital
Parkville, Victoria, 3052
Jane Sheehan, +61393455675, jane.sheehan3@rch.org.au
About this study
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:
- 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?
- Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?
Read the 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.
- Conditions
- Hearing Impairment
- Being tested
- Provision of standard audiological + fNIRS test results, Provision of standard audiological test results only
- Keywords
- Infants, Early intervention, functional near-infrared spectroscopy
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of standard audiological + fNIRS test resultsOther
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.
Provision of standard audiological test results onlyOther
The provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included.
| Study group | Role | What they receive |
|---|---|---|
| Provision of standard audiological + fNIRS test results | Experimental | 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. Receives: Other: Provision of standard audiological + fNIRS test results |
| Provision of standard audiological test results only | Active comparator | 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. Receives: Other: Provision of standard audiological test results only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: Between each infant's completed fNIRS testing session and 2 months after
Secondary outcomes (1)
Parental/Guardian perception of acceptability of fNIRS test process and usefulness of fNIRS test results
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.
Measured: Within 2 weeks after their child's fNIRS testing session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start2 May 2023
- Primary completion28 Apr 2028 (estimated)
- Study completion28 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hearing ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The intervention (provision of additional fNIRS information) will be applied to audiologists in a cross-over design, wherein each audiologist will receive the anonymized current audiological information about a particular infant twice: once with, and once without the additional fNIRS information. Each time, the audiologist will answer questions about key management decisions via a questionnaire and rate their confidence in their decision using a sliding scale. The change in confidence (difference between the two sliding scale answers for the audiologist) when having access to additional fNIRS information will be the raw data analysed. To test the main hypothesis (that including fNIRS information increases confidence in making management decisions) separately for different hearing loss category groups and different points in the care pathway, 232 infants will be recruited to undergo fNIRS testing, divided into subgroups each with target numbers based on power calculation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Bionics Institute of Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colette McKay, The Bionics Institute of Australia
- Investigators
- Professor Colette McKay, Principal investigator, The Bionics Institute of Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847426
- Sponsor's protocol ID
- 90457
- Status last verified
- Aug 2025
- First submitted
- 27 Apr 2023
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Publications
Mao D, Wunderlich J, Savkovic B, Jeffreys E, Nicholls N, Lee OW, Eager M, McKay CM. Speech token detection and discrimination in individual infants using functional near-infrared spectroscopy. Sci Rep. 2021 Dec 14;11(1):24006. doi: 10.1038/s41598-021-03595-z.
PubMed 34907273Paranawithana I, Mao D, Wong YT, McKay CM. Reducing false discoveries in resting-state functional connectivity using short channel correction: an fNIRS study. Neurophotonics. 2022 Jan;9(1):015001. doi: 10.1117/1.NPh.9.1.015001. Epub 2022 Jan 18.
PubMed 35071689Shader MJ, Luke R, Gouailhardou N, McKay CM. The use of broad vs restricted regions of interest in functional near-infrared spectroscopy for measuring cortical activation to auditory-only and visual-only speech. Hear Res. 2021 Jul;406:108256. doi: 10.1016/j.heares.2021.108256. Epub 2021 Apr 28.
PubMed 34051607Zhou X, Sobczak G, McKay CM, Litovsky RY. Comparing fNIRS signal qualities between approaches with and without short channels. PLoS One. 2020 Dec 23;15(12):e0244186. doi: 10.1371/journal.pone.0244186. eCollection 2020.
PubMed 33362260Weder S, Shoushtarian M, Olivares V, Zhou X, Innes-Brown H, McKay C. Cortical fNIRS Responses Can Be Better Explained by Loudness Percept than Sound Intensity. Ear Hear. 2020 Sep/Oct;41(5):1187-1195. doi: 10.1097/AUD.0000000000000836.
PubMed 31985534Weder S, Zhou X, Shoushtarian M, Innes-Brown H, McKay C. Cortical Processing Related to Intensity of a Modulated Noise Stimulus-a Functional Near-Infrared Study. J Assoc Res Otolaryngol. 2018 Jun;19(3):273-286. doi: 10.1007/s10162-018-0661-0. Epub 2018 Apr 9.
PubMed 29633049
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Early Intervention in Hearing Impaired Children Using Functional Near-Infrared Spectroscopy (fNIRS)
- ClinicalTrials.gov ID
- NCT05847426
- Acronym / sponsor ID
- 90457
- Conditions
- Hearing Impairment
- Keywords
- Infants, Early intervention, functional near-infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Bionics Institute of AustraliaUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 28 Apr 2028 (estimated)
- Study completion
- 28 Apr 2028 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Is the experience of their infant having an fNIRS test acceptable and comfortable for the parents or care givers?
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention (provision of additional fNIRS information) will be applied to audiologists in a cross-over design, wherein each audiologist will receive the anonymized current audiological information about a particular infant twice: once with, and once without the additional fNIRS information. Each time, the audiologist will answer questions about key management decisions via a questionnaire and rate their confidence in their decision using a sliding scale. The change in confidence (difference between the two sliding scale answers for the audiologist) when having access to additional fNIRS information will be the raw data analysed. To test the main hypothesis (that including fNIRS information increases confidence in making management decisions) separately for different hearing loss category groups and different points in the care pathway, 232 infants will be recruited to undergo fNIRS testing, divided into subgroups each with target numbers based on power calculation.
| Arm | Type | Receives |
|---|---|---|
| Provision of standard audiological + fNIRS test results | Experimental | Other: Provision of standard audiological + fNIRS test resultsThe 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. |
| Provision of standard audiological test results only | Active comparator | Other: Provision of standard audiological test results onlyThe 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. |
Who may qualify
- Ages
- 24 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of standard audiological + fNIRS test resultsInfants 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. | Other | Provision of standard audiological + fNIRS test results |
| Provision of standard audiological test results onlyThe provision of test results to the audiologist will be the same as in the experimental arm, but without the fNIRS test results included. | Other | Provision of standard audiological test results only |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Background: PubMed 34907273Mao D, Wunderlich J, Savkovic B, Jeffreys E, Nicholls N, Lee OW, Eager M, McKay CM. Speech token detection and discrimination in individual infants using functional near-infrared spectroscopy. Sci Rep. 2021 Dec 14;11(1):24006. doi: 10.1038/s41598-021-03595-z.
- Background: PubMed 35071689Paranawithana I, Mao D, Wong YT, McKay CM. Reducing false discoveries in resting-state functional connectivity using short channel correction: an fNIRS study. Neurophotonics. 2022 Jan;9(1):015001. doi: 10.1117/1.NPh.9.1.015001. Epub 2022 Jan 18.
- Background: PubMed 34051607Shader MJ, Luke R, Gouailhardou N, McKay CM. The use of broad vs restricted regions of interest in functional near-infrared spectroscopy for measuring cortical activation to auditory-only and visual-only speech. Hear Res. 2021 Jul;406:108256. doi: 10.1016/j.heares.2021.108256. Epub 2021 Apr 28.
- Background: PubMed 33362260Zhou X, Sobczak G, McKay CM, Litovsky RY. Comparing fNIRS signal qualities between approaches with and without short channels. PLoS One. 2020 Dec 23;15(12):e0244186. doi: 10.1371/journal.pone.0244186. eCollection 2020.
- Background: PubMed 31985534Weder S, Shoushtarian M, Olivares V, Zhou X, Innes-Brown H, McKay C. Cortical fNIRS Responses Can Be Better Explained by Loudness Percept than Sound Intensity. Ear Hear. 2020 Sep/Oct;41(5):1187-1195. doi: 10.1097/AUD.0000000000000836.
- Background: PubMed 29633049Weder S, Zhou X, Shoushtarian M, Innes-Brown H, McKay C. Cortical Processing Related to Intensity of a Modulated Noise Stimulus-a Functional Near-Infrared Study. J Assoc Res Otolaryngol. 2018 Jun;19(3):273-286. doi: 10.1007/s10162-018-0661-0. Epub 2018 Apr 9.
- Individual participant dataSharing planned: Yes. 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
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Hearing Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor Colette McKay principal investigator
The Bionics Institute of Australia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of standard audiological + fNIRS test results and Provision of standard audiological test results only in people with Hearing Impairment, run by The Bionics Institute of Australia at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Colette McKay (+61 3 9667 7541, cmckay@bionicsinstitute.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847426, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.