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Artificial Intelligence-Driven Hearing Aids for Auditory Neural Disorders for individuals 12 years and above

Effectiveness of Deep Neural Network–Based Hearing Aids on Functional Hearing Outcomes in Participants Aged 12 Years and Older with Auditory Neuropathy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000556347
Enrollment
160
Registered
2026-05-01
Start date
2026-07-01
Completion date
2028-03-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study explores how advanced hearing aids using artificial intelligence (AI) can help individuals with auditory neuropathy to better understand speech in noisy environments. The research will compare these advanced devices to traditional hearing aids by testing how well individuals hear and identify the location of sounds in a laboratory setting and during a eight-week trial. The goal is to determine whether AI-hearing aids provide better speech clarity and listening comfort in complex situations. The findings will help improve recommendations for individuals with auditory neuropathy and determine whether advanced hearing technology is more capable at enhancing communication than traditional technology. Individuals participating in the study will contribute valuable insights into the daily challenges of listening in noisy environments.

Interventions

This study will evaluate TGA-approved Deep neural network (DNN)-enabled hearing aids to address listening challenges in individuals with auditory neuropathy. DNN-enabled aids will also be compared to conventional 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

This study will evaluate TGA-approved Deep neural network (DNN)-enabled hearing aids to address listening challenges in individuals with auditory neuropathy. DNN-enabled aids will also be compared to conventional 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. The hearing aids will be setup based on each participant's hearing thresholds. For participants identified to have elevated sound detection levels, hearing aids will be fit to National Acoustic Laboratory Non-linear 2 prescription targets. Real ear measures will be used to verify the aids are matching to prescription targets. For participants with auditory neuropathy but normal hearing thresholds, minimal amplification will be provided (5-10 dB between 1 - 8kHz). Additionally, maximum power output of aids will be reduced to ensure no sounds will be too loud for listener's with normal sound detection thresholds. For all participants, these hearing aids will be used during two key contexts: (1) laboratory testing and an (2) eight-week take-home trial. 1. In the laboratory-based assessment, Individuals with auditory neuropathy 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 2 tasks unaided (no device) and while wearing the devices (aided): 1.1 Speech perception in noise. For this task participants will need to listen to and repeat target sentences (AzBio sentences), which will be played sequentially from 2 loudspeakers positioned at 0 and 90 degrees azimuth while competing background noise (multi-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 +5dB and the participant will be seated in the centre of the room. This will take approximately 30 mins for all conditions (unaided, with DNN-based hearing aids and with directional microphone hearing aids). 1.2 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. 2. During the take-home hearing aid trial, participants will use two types of hearing aids — traditional directional microphone devices and advanced DNN-enabled hearing aids over an eight-week period (total). Participants will be encouraged to wear the devices as much as possible. Each device will be worn for four weeks, allowing participants to experience its benefits in real-world environments such as school (if applicable), home, or social settings. At baseline and at the end of each four-week trial, participants will complete a short set of self-administered questionnaires (including the Speech, Spatial and Qualities of Hearing questionnaire and the Abbreviated Profile of Hearing aid Benefit questionnaire) that captures perceptions of the hearing devices in daily life. It will take approximately 20 mins to complete the questionnaires. Device adherence will be monitored using the datalogging feature of the hearing aids, which provide an indication of the hours per day the hearing aids are worn. 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 four-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 individuals with auditory neuropathy.

Sponsors

University of Melbourne
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria for the auditory neuropathy (AN) group: 1. Age 12–17 years (paediatric cohort) or 18-65 years (adult cohort). 2. Clinical diagnosis of AN indicated by: - Absent/abnormal ABR consistent with AN, and - Present OAE and/or cochlear microphonic (current or documented historically). - Able to complete speech testing in English, and comply with study procedures. Inclusion criteria for the control group: Age- and sex-matched participants with sensorineural hearing loss not consistent with AN (i.e. normal ABR consistent with cochlear HL), matched on hearing thresholds and hearing configuration, no history of auditory processing disorders, and neurologically normal.

Exclusion criteria

Exclusion criteria: 1. The presence of an active external and/or middle ear pathology. Individuals with conditions such as untreated otitis media would be excluded, as these factors could interfere with the hearing aid fitting procedure. This will be determined using a case history, otoscopic examination and tympanometry (if warranted). 2.Individuals fitted with a cochlear implant 3. Individuals unable to wear a behind-the-ear hearing aid (i.e. individuals with anotia/microtia) 4. Inability to provide consent/assent or comply with protocol.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 3, 2026