Every year more than 12 million Americans visit their physicians for impacted earwax removal. This condition occurs when enough earwax accumulates to cause symptoms such as pain, fullness, itching, odor, tinnitus, discharge, cough, or hearing loss. The usual solution is to use the Ear & Bladder Syringe, which has been the standard of care since 1821. But it can be a frustrating tool for physicians and a painful experience for patients.

The founders of Tucson based SafKan, brothers Sahil and Aadil Diwan, saw a market opportunity. They designed and developed the first automated ear-cleaning device, OtoSet, for clinical use. OtoSet looks like a pair of headphones, but it can professionally clean a patient’s ear in just 35 seconds. The judges of the Protolabs Cool Idea! Award were impressed enough to make this design the latest winner.

The headphones have disposable silicone nozzles that spray a warm saline solution against the walls of the ear canal while extracting the solution and wax back into the nozzles and disposable outflow containers, avoiding messy spills. Long-term, SafKan plans to roll out a consumer version of the device but for now OtoSet will be administered by health care providers.

To develop OtoSet the Diwan brothers went through several iterations. Application engineers from Protolabs offered suggestions that help the brothers perfect their design.

The grant from the Cool Idea! Award removed the financial burden of the clinical trials, so the brothers could quickly place working prototypes in the hands of physicians.

“Without this grant, it would take more time,” said Sahil. “This allows us to build these devices, have them be the real deal, and get them to physicians quickly.”

From design to development
“While it’s pretty easy to design headphones on your computer and 3D print them,” said Sahil, “you then need to take that to the next level and start to commercialize it. Protolabs has been really helpful with our engineering team, using experience that we don’t have in-house to get our device ready to go to market.”

The Diwan brothers leaned on Protolabs’ expertise in Polyjet 3D printing and CNC machining, using 14 unique parts from the digital manufacturer. Once made, the parts for multiple devices were shipped to Tucson, Arizona, where they are assembled and tested by SafKan.

“One of the largest segments we serve as a digital manufacturing company is the medical and health care industry,” said Protolabs President and CEO, Vicki Holt. “So when the opportunity comes to support amazing products like OtoSet—devices that are solving real problems for its users—I’m more than thrilled with the fact that we can provide a manufacturing grant to do that.”

Since completing two clinical trials, OtoSet is going into a beta program in several cities including Seattle, San Francisco, Los Angeles, Tucson, Houston, and Philadelphia. With funding from the Cool Idea! Award, SafKan has developed industrial-grade prototypes that are being tested by more than 50 physicians across the country.

“The SafKan team has developed a brilliant concept and design for managing a condition we commonly see in the office setting,” said Dr. Gary Kato, a primary care physician. “As an educator of primary care physicians, I can envision physicians of the future using SafKan’s device as an essential tool in patient care. Their innovative device is unmatched in the industry.”

In the future, SafKan plans to make the product available to consumers, so that the millions of Americans that typically visit their physicians for ear syringing no longer have to.

Protolabs
protolabs.com

SafKan
safkanhealth.com