- It’s been named as one of TIME’s “Best Inventions of 2025.“
- Won the World Congress of Audiology “Innovation Prize” and was the Gold Winner in the Health: Innovation category at The Anthem Awards 2025.
- Won the overall pitch competition at West Tech Fest.
- Received the prestigious CES Innovation Awards® Best of Innovation in Digital Health for 2026.
While medtech breakthroughs are often complex, Earflo’s device demonstrates how simple, thoughtful design can be transformative.
Solving an intractable pediatric issue
Earflo’s next-gen “sippy cup” is a novel, stress-free way to treat negative middle ear pressure that leads to otitis media with effusion (OME), a build-up of non-infected fluid in the middle ear that can cause muffled hearing, a feeling of fullness in the ear, or balance problems. OME, which often follows a cold or upper respiratory infection, is one of the most common pediatric concerns, affecting more than 90% of children before they reach age five. The condition triggers 2.2 million pediatrician visits per year in the U.S alone and costs Americans $5 billion per year.
The effects of OME go beyond discomfort; the condition can lead to hearing loss and developmental delay. Previously, surgery was the only treatment option available for young children, with many parents fearing the risks that accompany general anesthesia.
Now, with the Earflo medical device, there is a non-invasive way to address the middle-ear pressure that drives OME that’s as easy as sipping from a cup. As the child drinks, their nose presses into a silicone mask that delivers a gentle puff of air into the nasal cavity, coordinated with swallowing, to open the eustachian tube. The device is equipped with a sensor to precisely control pressure and indicate when the treatment has been successfully administered. A companion app guides parents, tracks progress and keeps children engaged through positive reinforcement.
Major achievements fuel momentum
As a former participant in Fogarty’s Company Accelerator Program (CAP), the Earflo team benefited from feedback on the device design and development that has led to successful clinical trials. In fact, it was Fogarty’s advisors who helped them choose a go-to market strategy that targets consumers directly.
Data obtained thus far has been very positive, with 90% of the testers avoiding surgery and 88% experiencing significantly improved hearing. Results were published in the American Academy of Otolaryngology, the premier journal for ENT clinicians globally, and Earflo also presented its findings at the 2025 American Academy of Otolaryngology Head and Neck Surgery National Conference.
The device has been submitted to the FDA for clearance under the 510(k) pathway and is currently in review. The team anticipates receiving approval in early 2026 and plans to commercialize first in the United States, followed by Australia.
The company has raised a significant amount of seed funding, including from the Australian Medical Angels, the country’s largest syndicate of clinician investors, and recently received a $415,000 social-mission investment from the Richard King Mellon Foundation that will support FDA clearance, manufacturing and launch preparation efforts.
Seasoned talent drives achievement
In addition to working with Fogarty Innovation, the Earflo team has ties to Stanford Biodesign. Two of the cofounders—CTO Matt Oldakowski, a biomedical engineer from Perth, Australia; and Dr. Jozef Bartunek, a cardiologist from Aalst, Belgium—were fellows in the Stanford Biodesign Global Faculty in Training (GFIT) program, where part of their work involved shadowing ear nose and throat (ENT) specialists. That’s when they first recognized the prevalence of OME and the risks of surgical treatment – and started looking for a better way.
The core team also includes CEO Dr. Intan Oldakowska, who was previously the co-director of Biodesign Australia and Perth Biodesign; Dr. Steve Kargotich, Stanford’s SPARK global executive director; and Dr. Peter Santa Maria, a surgeon scientist.
The company also recently added two biomedical engineers in Perth to help scale the quality management system, as well as an expert in quality manufacturing. They have also brought on
chief marketing officer, Michelle Weil, who has over 15 years of experience in the direct-to-consumer health and wellness industry.
A solution that resonates
Given the response to date, the Oldakowskis feel confident the device will be well-received once approved. For example, the booth Earflo hosted at the American Academy of Pediatrics and the American Academy of Otolaryngology Head and Neck Surgery conferences drew significant attention. “We had more than 500 clinicians join our mailing list,” said Matt.
Much of the interest was organic, with conference attendees saying they’d heard about the device from colleagues or at panels they attended. “Rather than us really aggressively pitching, we were getting a receptive outcome just through word of mouth,” he said, noting that this included strong interest from clinician investors.
Oldakowski attributes part of the interest to the credibility provided by Dr. Peter Santa Maria, but also because physicians recognize how practical it is. “They see patients with chronic ear infections multiple times a day, and while they might have previously taken a wait-and-see approach, they are eager to have an alternative tool in their toolbox,” he said.
But the strongest validation comes from parents and children themselves. Parents have reported that the device was easy to use, and the app proved to be a hit with kids; a plus for ensuring compliance. “We’re building on that with a gamification storyline where the kids are involved in a two-week mission that will spur them to use the device every day,” Intan Oldakowska said.