Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000503426p
Ethics application status
Submitted, not yet approved
Date submitted
6/05/2025
Date registered
22/05/2025
Date last updated
22/05/2025
Date data sharing statement initially provided
22/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of advanced hearing aid technology for children with listening difficulties
Scientific title
Efficacy of Deep Neural Network and Directional Microphone Hearing Aids for Children with Listening Difficulties
Secondary ID [1] 314375 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Listening Difficulties 337371 0
Auditory Processing Disorder 337372 0
Autism Spectrum Disorder 337373 0
Attention Deficit Hyperactivity Disorder 337374 0
Condition category
Condition code
Ear 333752 333752 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will evaluate two types of TGA-approved hearing aids to address listening challenges in children: Deep neural network (DNN)-enabled hearing aids and traditional directional microphone hearing aids.

DNN hearing aids use artificial intelligence to process and enhance speech signals in complex acoustic environments, such as classrooms, by effectively separating speech from background noise.

In comparison, directional microphone hearing aids rely on beam-forming technology to focus on sound from a specific direction (usually in front of the listener) while reducing background noise.

For all participants, these hearing aids will be used during two key contexts: (1) laboratory testing and a (2) four-week take-home trial.

1. In the laboratory-based assessment, children will take part in structured auditory tests, administered by a Research Audiologist, to measure their ability to attend to and understand speech in challenging listening environments. Participants will be asked to perform 3 tasks unaided (no device) and while wearing the devices (aided):

1. Speech perception in noise. For this task participants will need to listen to and repeat target sentences (City University of New York-like (CUNY-like) sentence list), which will be played sequentially from 3 loudspeakers positioned at 0, 90, and 180 degrees azimuth while competing background noise (4-talker babble) is played from 4 loudspeakers positioned in the corners of the room). The stimuli will be delivered at a signal to noise ratio of 0dB and the participant will be seated in the centre of the room. This will take approximately 40 mins for all conditions (unaided, with DNN-based hearing aids and with directional microphone hearing aids).
2. Ability to locate sounds. This will require the participants to sit in the middle of a 16-channel loudspeaker array and pinpoint which of the speakers are producing a sound. This will take approximately 30 mins for all conditions.
3. Visual and auditory attention. This will be assessed using a computer program called Integrated Visual and Auditory continuous performance test - Quick Screening (IVA-QS). For this assessment participants will need to click a mouse button whenever they hear or see a particular number. This assessment will also be administered in the presence of background noise and will take approximately 30 mins to complete for all conditions.

2. During the take-home hearing aid trial, children will use two types of hearing aids — traditional directional microphone devices and advanced DNN hearing aids — over a four-week period. The hearing aids will be fitted by a Research Audiologist using minimal amounts of gain (5dB across 250 Hz - 8kHz) and the maximum power output of the devices will be set to 85dB to ensure damaging levels of sounds cannot be produced by the devices. Participants will be encouraged to wear the devices as much as possible, especially in the classroom setting. Each device will be worn for two weeks, allowing children to experience its benefits in real-world environments such as school, home, or social settings. At baseline and at the end of each two-week trial, children will complete a short set of self-administered (with the assistance of a parent) questionnaires (including the Listening Inventory for Education - Revised and the Paediatric Quality of Life Inventory) that captures perceptions of the hearing devices in daily life. It will take approximately 20 mins to complete the questionnaires. No washout period will be used in the study.

A washout period will not be used in this study because the interventions being tested, DNN-hearing aids and traditional directional microphone hearing aids are non-pharmacological and do not have lingering physiological effects that could influence subsequent testing. The devices function only when actively worn and are removed at the end of each testing session or daily use. Unlike pharmacological interventions, hearing aids do not leave residual effects that could interfere with participants’ performance in future testing or with the alternative device.

Additionally, the study design ensures each device is tested over a two-week period during the take-home trial, which allows participants sufficient time to become familiar with each hearing aid type. During the laboratory-based testing sessions, a randomised testing order will ensure unbiased comparisons between the devices. Since there is no physiological carryover between conditions, a washout period is unnecessary and would only increase the burden on participants without adding scientific value to the study.

These interventions aim to identify which hearing aid technology offers superior outcomes for children with normal hearing thresholds but have significant listening difficulties (especially in background noise).
Intervention code [1] 330987 0
Rehabilitation
Intervention code [2] 331075 0
Treatment: Devices
Comparator / control treatment
DNN-enabled hearing aids will be compared against (i) no intervention and (ii) 'traditional' hearing aids with directional microphone technology. Since device options are not currently used to treat this cohort in the clinical setting, it is not expected that any child will be wearing a device for their listening difficulties prior to the start of the trial. Hence, the 'no intervention' period will be taken as baseline (prior to commencement of the trial).

Potential benefits will be assessed in children with listening difficulties (including auditory processing disorder, autism, and attention hyperactivity disorder). A control group of gender, age and hearing level matched peers will also be included. This group will also complete both the auditory laboratory assessments and the 4-week trial.

A washout period will not be used in this study because the interventions being tested, DNN-hearing aids and traditional directional microphone hearing aids are non-pharmacological and do not have lingering physiological effects that could influence subsequent testing. The devices function only when actively worn and are removed at the end of each testing session or daily use. Unlike pharmacological interventions, hearing aids do not leave residual effects that could interfere with participants’ performance in future testing or with the alternative device.
Control group
Active

Outcomes
Primary outcome [1] 341336 0
Functional hearing ability
Timepoint [1] 341336 0
Baseline and after each device trial (e.g. end of 2 and 4 weeks).
Primary outcome [2] 341475 0
Quality of life
Timepoint [2] 341475 0
Baseline and after each device trial (e.g. end of 2 and 4 weeks).
Secondary outcome [1] 447163 0
Localisation
Timepoint [1] 447163 0
Baseline unaided (10 mins), with DNN-hearing aids (10 mins) and with directional microphone hearing aids (10 mins). This will enable a comparison in the ability for this task between interventions.
Secondary outcome [2] 447164 0
Attention in background noise
Timepoint [2] 447164 0
Baseline unaided (10 mins), with DNN-hearing aids (10 mins) and with directional microphone hearing aids (10 mins). This will enable a comparison in the ability for this task between interventions.
Secondary outcome [3] 447696 0
Speech perception
Timepoint [3] 447696 0
Baseline unaided (15 mins), with DNN-hearing aids (15 mins) and with directional microphone hearing aids (15 mins). This will enable a comparison in the ability for this task between interventions.

Eligibility
Key inclusion criteria
1. School-aged children (8-18 years) with normal sound detection but confirmed auditory processing disorder and no known co-morbidities or learning issues.

2. School-aged children (8-18 years) with normal sound detection but listening deficits associated with neurodevelopmental disorder. This cohort will include individuals with a confirmed diagnosis of autism spectrum disorder and/or children with Attention Deficit Hyperactivity Disorder (ADHD).

3. A control group of age, gender and hearing level matched children with no known auditory processing, neurodevelopment disorders or learning issues.
Minimum age
8 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
An exclusion criterion for this study is the presence of active middle ear pathology or any condition that could affect the integrity of hearing required for the research tests. Children with conditions such as untreated otitis media or those with significant conductive hearing loss would be excluded, as these factors would interfere with the accurate measurement of auditory processing abilities. This will be determined using a case history, otoscopic examination and tympanometry (if warranted).

Additionally, children with co-morbidities beyond autism spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD), such as intellectual disabilities, severe communication disorders, or neurological conditions unrelated to auditory processing, will be excluded. These additional factors may confound the study results and make it difficult to isolate the specific effects of the hearing aids being tested. The presence of these additional factors will be determined through a case history.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318893 0
Commercial sector/Industry
Name [1] 318893 0
SONOVA AG
Country [1] 318893 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 321362 0
None
Name [1] 321362 0
Address [1] 321362 0
Country [1] 321362 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317509 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 317509 0
Ethics committee country [1] 317509 0
Australia
Date submitted for ethics approval [1] 317509 0
21/05/2025
Approval date [1] 317509 0
Ethics approval number [1] 317509 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141270 0
Prof Gary Rance
Address 141270 0
The University of Melbourne, Department of Audiology and Speech Pathology, 550 Swanston St, Carlton, VIC 3053
Country 141270 0
Australia
Phone 141270 0
+61390355342
Fax 141270 0
Email 141270 0
[email protected]
Contact person for public queries
Name 141271 0
Julien Zanin
Address 141271 0
The University of Melbourne, Department of Audiology and Speech Pathology, 550 Swanston St, Carlton, VIC 3053
Country 141271 0
Australia
Phone 141271 0
+61 422795409
Fax 141271 0
Email 141271 0
[email protected]
Contact person for scientific queries
Name 141272 0
Julien Zanin
Address 141272 0
The University of Melbourne, Department of Audiology and Speech Pathology, 550 Swanston St, Carlton, VIC 3053
Country 141272 0
Australia
Phone 141272 0
+61 422795409
Fax 141272 0
Email 141272 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.