What is the need you set out to address?

Matt: Our focus is on treating children with otitis media with effusion in order to restore hearing while avoiding surgery. The population we're addressing is kids between the ages of one and five years old because 89% of kids with the disease are under five. It’s also the time when children are most affected by the condition because they're learning how to talk and socialize. There's strong evidence showing that if children don’t hear well in this age range, they quickly begin to fall behind and can experience significant developmental delays. 

Intan: Otitis media with effusion is caused by the poor function of the eustachian tube, which is the canal that links the middle ear to the nasal-sinus cavity. The eustachian tube helps balance pressure and drain fluid from the middle ear. When it’s not working properly, fluid can build up behind the eardrum. When the eardrum can’t move freely, that causes hearing loss. Some children experience this for a few weeks, then the condition resolves on its own. Others have it for many months or years and require treatment. The most effective intervention currently involves surgery to place ear tubes to drain fluid and help balance pressure in the ear.  

What key insight was most important to guiding the design of your solution?

Matt: One major insight was that it was such a simple mechanical problem. And this was one of the filters we used when screening needs: We were looking for simple mechanical problems that our mechanical minds could solve! 

"We were looking for simple mechanical problems that our mechanical minds could solve!"

Our early research revealed some other important insights. There was a paper by a German physician who sat adult patients in a chair, angled their heads, and used a pneumatic otoscope to pressurize the eardrum and a politzer bag to pressurize the nasal cavity. He found that if he synchronized the three movements, he could clear 90% of effusions in adults. That helped convince us that the mechanism of action was sound. But when we started to investigate the devices that used this kind of pressure to open the eustachian tube and ventilate the middle air, we initially didn’t understand why they weren’t more broadly adopted. We bought them, started to play around with them, and read all the Amazon reviews. That’s when it became clearly apparent that they weren't practical at all, especially for children who are most impacted by the disease. With one device, you have to hold it to your nose, put some water in your mouth, and then press a button while you're swallowing. Even adult patients have problems coordinating that sequence of events. With another device, you have to blow up a balloon with your nose. Again, it’s very difficult, even for adults, to inflate the balloon and maintain the appropriate pressure without having air leak out. As a result, these devices really can’t be used for kids under five years old. The clinical trials show reasonably good data, but the average patient in these studies is age seven, which is outside critical one to five-year time frame. We realized that to effectively serve young children, we had to design something for a totally different user. 

Intan: One other challenge with the current devices on the market is that the pressure is uncontrolled. So, it can be quite shocking for a young child when they’re able to coordinate their movements and use a device properly to clear the pressure in the ear. Many of them don't want to use it again because the sensation is so unpleasant.

How does your solution work?

Matt: One thing children learn to do when they’re quite young is drink from a sippy cup. So, our solution leverages the basic form factor of a sippy cup, but with a built-in electric air pump to pressurize the nasal cavity when a child is naturally drinking. In order to get their lips on the sucker, the child has to press their nose into mask. That creates a seal so that when they swallow the fluid from the cup, their soft palate retracts to the back of the throat as the device initiates a brief and low-pressure puff of air that the child barely notices. But, because it’s precisely synchronized with the swallowing, it opens the eustachian tubes and ventilates the middle ear. That allows the fluid build-up to flow out of the middle air, which restores hearing. Importantly, the EarFlo device is sophisticated enough to make the process very simple for kids; just drink from the cup!

To help motivate children and make the experience fun, the device is paired with a game that can be played on a smartphone. In the game, they have a rocket that moves upwards based on intranasal pressure. When they get up to the right pressure, the rocket reaches a star. This helps them train themselves on how to use the device, and they get digital rewards each time they complete a session. Right now, each session requires them to get the desired effect five times. But we intend to study whether doing it more will cause children to get better even faster or whether five times is really necessary.

At what stage of development is the solution?

Intan: We’re at a clinical trial stage. We completed a single-use pilot study, using an early prototype, with good results. Thirty-one children, with an average age of about three years old, used the device once in a controlled environment and approximately 65% experienced a clinical improvement. We’ve now just started a pilot daily-use study with an injection-molded prototype that families can take home for four weeks. They'll use the device daily and we’ll check their diagnostic measures at the beginning, middle, and end of the study. 

Members of the EarFlo team: Peter Santa Maria, Steve Kargotich, Intan Oldakowska, and Matt Oldakowski.