NIRGenie

Game-changing device accelerates intervention in infants and children with hearing and language disorders.

NIRGenie, a Bionics Institute spinout company, has designed and developed a new device that provides clinicians with information critical to the early intervention of hearing loss and language delay in infants and children.

EarGenie® is a device consisting of proprietary hardware, software and AI utilising near-infrared spectroscopy (fNIRS) to measure changes in the brain’s oxygenation levels in response to sound stimuli allowing clinicians to accurately and objectively determine what treatment to administer.

NIRGenie’s founding team at the Bionics Institute are Professor Colette McKay, Translational Hearing Research and Principal Scientist; Dr Julia Wunderlich, audiologist; Dr Darren Mao, engineer; and Dr Gautam Balasubramanian, data scientist. Jeffrey Ng is the inaugural NIRGenie CEO as well as a Venture Creator from the University of Melbourne.

The challenge

One in every 500 children in Australia is born with moderate or severe-to-profound hearing loss, with 10 per cent of this cohort suffering from Auditory Neuropathy, where sounds are heard but not transmitted accurately to the brain. In addition, children who have special needs, such as cerebral palsy or neuro-degenerative disorders, often have impaired hearing.

Currently a universal newborn hearing program screens babies for hearing loss, after which babies with potential hearing problems are referred for further diagnostic testing with an audiologist. However, testing and technology used by audiologists are limited in being able to pinpoint the exact extent of hearing impairment in the 10 per cent of children with hearing loss who have auditory neuropathy.

Knowing whether a hearing aid is programmed accurately for an infant and knowing whether a cochlear implant would be more appropriate than a hearing aid are challenging questions that are difficult to determine at early ages when verbal or behavioural responses are not reliable. However it is critical that these questions are answered at the earliest possible age, as any delay in providing the correct intervention will lead to language delay, with subsequent impact on education, social life, and health.

With 95 per cent accuracy, EarGenie® fills the information gaps to enable audiologists to accelerate their intervention.

The innovation

While working at the Biomedical Imaging Institute at Manchester University in the UK, Professor McKay became interested in the potential of a specific type of light technology (functional near-infrared spectroscopy or fNIRS) to help diagnose hearing loss in babies and young children.

When Professor McKay returned to Australia in 2013, she joined the Bionics Institute and established the fNIRS Hearing Research Laboratory. Since this time, with a multi-disciplinary team, she has developed the technology behind EarGenie.

“People vary in how much sound distortion they experience with their hearing loss and how much amplification they need, but we can’t test babies for this because we can’t sit them in front of a speaker and say ‘repeat the words you hear’,” Professor McKay says.

“No objective system can tell you reliably if a baby can discriminate between speech sounds and no current system can objectively assess hearing in cases of auditory neuropathy. EarGenie® will enable audiologists to know how severe a baby’s hearing loss is sooner, rather than having to wait to assess children when they are older.”

NIRGenie was established to develop a commercial prototype and take EarGenie to market.

“EarGenie® will fast track early intervention and lead to better hearing and language development in children. We’ve been able to develop and refine a design that is now wireless and lightweight and is capable of being manufactured on a larger scale,” Mr Klupacs says.

The support

NIRGenie has raised pre-seed investment from the Bionics Institute and the University of Melbourne. The Victorian Medical Research Acceleration Fund, the National Health and Medical Research Council and the Medical Research Future Fund have also provided grant funding for the development of EarGenie technology and its application in clinical trials.

The University of Melbourne, through the appointment of Jeffrey Ng from its Genesis Ventures team, has also provided intensive commercial expertise.

“The EarGenie® team had a great device but, initially, the commercial value proposition was quite weak because they were targeting a small market. Through a series of workshops, we identified other applications where the technology can be applied,”  Mr Ng says.

“The pre-seed investment has taken EarGenie® to a commercial setting – we now know the value proposition, market and target applications. NIRGenie has taken a big step from being an interesting and promising research project to becoming a company with a purpose to commercialise EarGenie®.”

The team

NIRGenie was founded in late 2022 as the commercial entity to commercialise the research, development and testing of the EarGenie device being carried out by Professor McKay and a team of software and systems engineers, data scientists and audiologists including Dr Julia Wunderlich, Dr Darren Mao and Dr Gautam Balasubramanian.

“As we move forward, we have needed to transform ourselves from a research team to a development team and we’ve had to learn about business plans and how to pitch to investors – we never stop learning how to do things better,” Professor McKay says.

“Jeff opened our eyes as to how to think like a business and to realise that we can’t be a one-trick pony. Together, we have ensured EarGenie® is a sound commercial proposition.”

Robert Klupacs and Jeffrey Ng have been instrumental in helping to establish NIRGenie, secure pre-seed funding and to enable EarGenie to move closer to commercialisation.

“The University’s Genesis Venture Creator team put us through the wringer from a due diligence perspective – and they had to. We had to develop a story to illustrate what the product is good for, what it needed to look like to be usable in a commercial setting and to identify the market opportunity,” Robert says. “But we are now seeing a lot of opportunities that would not have got to the point they have without the involvement of the University.”

"I come from a startup background and know what investors look for and how to put a business plan in place and execute it," says Jeffrey. "Medical research institutes generally aren’t set up for that. They get to a certain point but don’t know how to get to the next stage and all the way to starting up a company and securing external funding from investors. That’s where investment funds and startup teams like the University’s Venture Creators can add a lot of value."

The partners

NIRGenie is a 100 per cent subsidiary of the Bionics Institute that has received investment and support from a number of sources. As well as an investment of $1.9 million from the Bionics Institute and $500,000 from the University of Melbourne, NIRGenie has received $500,000 from the Victorian Medical Research Acceleration Fund (Round 6). A further $392,940 has been awarded by the Medical Research Future Fund and nearly $1.18 million by NHMRC Development Grants.

“We set up the company in-house and vended in the intellectual property pre-emptively in a company that we own and continue to develop,” Mr Klupacs says.

The Intellectual Property remains with the Bionics Institute with an option agreement for the IP to be assigned to NIRGenie.

The future

In the next few months, NIRGenie will deploy a Minimum Viable Product (MVP) prototype EarGenie device that will be assessed by key opinion leaders in Denmark, the UK and the US.

A market survey of audiologists across the US has been completed to gauge levels of interest in EarGenie and how audiologists believe it will add value within their clinics. NIRGenie is also undertaking the pre-approval submission process with the FDA ahead of starting the full approval process for EarGenie.

“We are also talking with the major commercial players in this space – existing diagnostic audiology companies and potential customers - to make them aware of EarGenie® and explore how we can engage with them to commercialise this device and bring it to market. We are building the commercial context around the technology and accelerating its path to market," Jeffrey Ng says.