Around 650,000 Australian children are affected by ear infections every year and 1 in 15 have surgery for grommets by age three. Earflo’s FDA-cleared connected device treats the negative pressure leading to ear fluid and infections – providing families with an at-home solution before surgery. We spoke with CEO and Co-Founder Dr Intan Oldakowska about how ANDHealth+ will help Earflo go global, the power of at-home care, and the similarities between rock climbing and building a healthtech startup.

Tell us about your company and the problem you're trying to solve.

Earflo is a connected device company transforming the treatment pathway of chronic ear infections in children. Chronic ear infections and middle ear fluid affect millions of children worldwide and are one of the leading causes of hearing loss in preschool-aged children. Left untreated, they can impact hearing, speech, learning, behaviour and social development.

Today, the primary treatment pathway for persistent disease is ear tube surgery under general anaesthesia, making it one of the most common surgical procedures performed in children. Many families are understandably concerned about surgery and often have limited treatment options available before reaching that point.

Earflo has developed an FDA-cleared at-home medical device that helps restore normal middle ear pressure and ventilation during normal drinking. Our goal is to provide families with a safe, effective and accessible treatment option that can reduce the need for surgery while improving hearing and quality of life for children.

Founded out of the Stanford Biodesign program by biomedical engineers and ENT surgeons, Earflo combines clinically validated technology with a scalable direct-to-consumer and clinician-referred commercialisation strategy to improve outcomes for millions of families.


Why did you apply for ANDHealth+ and what are you hoping to achieve through the program?

Earflo is entering an exciting phase of growth following FDA clearance and commercial launch in the United States. While we have made significant progress in product development, clinical validation, regulatory clearance and market entry, scaling a medical device company requires expertise that extends beyond these areas.

We applied to ANDHealth+ because of its strong track record helping Australian medtech companies navigate commercialisation, reimbursement, market access, partnerships and international growth. We believe the program's network of healthcare leaders, investors, clinicians and industry experts can help accelerate our path to becoming a globally impactful healthcare company.

Through the program, we hope to strengthen our commercial strategy, build strategic partnerships, generate additional health economic evidence and better position Earflo for large-scale adoption across both healthcare systems and direct-to-consumer channels.

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What have been the biggest challenges in developing or scaling your solution to date?

One of the biggest challenges has been translating a clinically effective concept into a product that can be safely and effectively used by parents at home. Medical devices for home use require far more than simply demonstrating clinical efficacy. We spent significant time addressing biocompatibility requirements, human factors engineering, usability testing and regulatory expectations to ensure the product was safe, intuitive and suitable for children.

Human factors was particularly important because our users are not healthcare professionals. The device needed to be simple enough for a parent to use correctly with a young child while still delivering a clinically meaningful outcome. This required multiple iterations of the product design, instructions for use, and user testing.

Another challenge has been communicating the opportunity to investors and stakeholders. Ear infections are one of the most common childhood conditions, yet many people underestimate the burden of disease. We have had to demonstrate not only that Earflo works clinically, but that there is an opportunity to fundamentally change the treatment pathway for millions of children and that this represents a huge market opportunity.

Finally, building a global medical device company and leading teams across Australia and the United States has presented unique challenges. Coordinating teams, advisors, clinical partners and stakeholders across different time zones and healthcare systems requires strong communication, trust and alignment around a shared mission. While this has added complexity, it has also demonstrated that a globally connected team can successfully develop, validate and commercialise innovative medical technologies, while building the foundations for international growth from the very beginning.

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What evidence or early results have you seen so far that validate your solution?

We have generated strong clinical, regulatory and commercial validation.

Published clinical studies have demonstrated that 86% of children experienced immediate improvement in middle ear pressure, 86% showed significant hearing improvement after four weeks of daily Earflo treatment, and 89% of children recruited at the ENT surgeon’s office, who were candidates for ear tube surgery, avoided surgery following treatment.

Earflo has received FDA 510(k) clearance, allowing commercial launch in the United States. The company has also been recognised with a CES Best of Innovation Award in Digital Health and inclusion in TIME's Best Inventions of 2025.

Beyond these milestones, we have seen strong engagement from both clinicians and parents. More than 500 clinicians signed up to our mailing list at major US conferences for paediatricians and ENT surgeons and we continue to build partnerships with hospitals, health systems and outreach organisations that share our vision of reducing the burden of chronic ear disease in children.

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Tell us about your background and/or founder journey.

I am a biomedical engineer and entrepreneur passionate about identifying significant unmet healthcare needs and developing practical solutions that improve patient outcomes. My medtech entrepreneurship journey began during my PhD, when I co-founded REX Ortho to develop innovative orthopaedic implants to reduce screw fixation failure. Since then, I have held leadership roles spanning medical technology innovation, research and education, including co-founding and leading ventures such as REX Ortho and Earflo, helping establish Perth Biodesign and Biodesign Australia, and teaching innovation and medical device development to biomedical engineering students at the University of Western Australia.

Earflo was born from a simple but important observation: despite chronic ear infections being one of the most common conditions affecting children, families had very few treatment options available before surgery. Together with my co-founders, including internationally recognised ENT surgeon-scientist Dr Peter Santa Maria, we set out to develop a treatment that could be delivered safely and effectively at home.

The journey has involved years of product development, clinical research, regulatory submissions, fundraising, and countless conversations with clinicians and families. Seeing children improve their hearing and avoid surgery has reinforced our belief that this problem is worth solving and motivates us to continue building the company.

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Where do you see the biggest opportunities for innovation in the Australian healthcare system?

I believe one of the greatest opportunities lies in shifting care from hospitals and specialist clinics into the home. Many chronic conditions could be managed earlier, more conveniently and more cost-effectively if patients had access to evidence-based technologies that empower them to participate in their own care.

Australia has world-class clinicians, researchers and healthcare infrastructure, but we often struggle to translate innovation into widespread adoption. There is a significant opportunity to improve pathways for reimbursement, procurement and evidence generation so that innovative technologies can reach patients earlier.

I also believe there is enormous potential to improve healthcare access for regional, rural and Indigenous communities through connected medical devices that reduce dependence on specialist services concentrated in major metropolitan centres.

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What's something the sector may not know about you?

Outside of healthcare innovation, I am an avid rock climber and spend much of my spare time training, climbing and planning outdoor adventures. One of the things I enjoy most about climbing is that it constantly forces you to solve difficult problems with limited information and adapt when things do not go according to plan.

In many ways, building a healthcare startup feels remarkably similar. Both require persistence, resilience, teamwork, risk management and the willingness to keep moving forward despite uncertainty. Fortunately, both are also incredibly rewarding when you finally reach the summit.

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ANDHealth is supported to deliver the ANDHealth+ program by the Australian Government through the Medical Research Future Fund (MRFF) 2024 BioMedTech Incubator Program.

Applications for the next intake of the ANDHealth+ program are expected to open in August 2026.

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