Earwax Remover Heads to Market with $8 Million, FDA Clearance & Viral TikTok Video – GeekWire

SafKan OtoSet earwax removal device. (Safkan photos)

The man clicks a button on a device that sits on his ears like a giant headphone. The engine is running. fluid flows. “It’s strangely satisfying,” he says in the TikTok video, which has more than 15 million views.

More people might have the same sentiment if Seattle had its way.

SafKan Health is behind the ear cleaning device that removes earwax and aims to replace current clinical methods of removing unwanted material.

“We want to basically do for your ears what Sonicare and the electric toothbrush companies have done for your teeth,” CEO Suhail Diwan said, in an interview with GeekWire.

The startup recently raised $8 million to support expanded manufacturing and marketing efforts for its OtoSet device, which has been placed in hundreds of clinics.

Diwan co-founded the company in 2016 with his brother, Adel Diwan. The following year she won first prize in the Seattle Angel Conference startup competition.

At the time, the device was just a blueprint, born out of Aadil’s problem with earwax. Since he was a child, Adil has suffered from earwax buildup – one of the millions of people affected worldwide.

About 10% of children and 5% of adults have excessive or impacted earwax, and an estimated 8 million earwax removal procedures are performed annually in U.S. clinics, according to the American Academy of Otolaryngology. Symptoms include hearing loss, pain, dizziness, and tinnitus.

Doctors usually irrigate the canal with fluids to dislodge the wax, which can take a long time. Another option involves suctioning by a specialist.

Sahel Diwan said OtoSet is faster and easier to use. It uses both irrigation and suction to clean the ears and takes just minutes.

SafKan founders Suhail Diwan (left) and Adel Diwan. (Photo by SafKan)

The brothers founded the company when Suhail was 26 and Adel was 23 and had just completed his undergraduate degree in bioengineering. Funded with $2.5 million in seed funding, the small team built prototypes using a 3D printer and tested them in collaboration with a clinical partner in the Seattle area.

In 2020, the FDA authorized the device’s use by physicians through a regulatory pathway that requires the startup to demonstrate “substantial equivalence” to the current device’s safety and effectiveness.

“Our quintessential equivalent was literally a syringe,” Diwan said.

Diwan added that consumers buy a lot of “highlights” to clean their ears. “You’ll find them on Amazon,” Dewan said. “Lots of crazy stuff.”

Products include small scoops with miniature cameras, drill-like devices that rotate, and ear candling kits, which literally include a candle. Some devices are dangerous. In contrast, the OtoSet is the only FDA-cleared device for earwax removal, Diwan said.

Dewan said the FDA’s insistence on seeing SafKan’s data helped the company make a better product. “Going through this process is rigorous, and it takes a lot of time,” he said. “It really makes you button everything.”

The Food and Drug Administration greenlit the device at the height of the pandemic, and so the company didn’t begin its beta launch until late 2021, bringing the device in person to professional conferences.

“We will be the busiest booth, because everyone can see the product and try it for themselves,” Dewan said. “It was wild.”

Doctors have now treated thousands of people with this device, which retails for $1,759 for a “six-month package” on the company’s website.

In another milestone, SafKan signed a partnership this year with hearing aid maker Beltone, which will offer OtoSet to its service providers. Dewan said that earwax buildup is a major cause of damage to hearing aids.

The company has not yet released the data publicly, but it plans to collect and publish more this year, which Diwan said is critical with the goal of replacing existing methods in the clinic.

SafKan is now modifying the device’s design to optimize it for large-scale manufacturing with contractors in India and China, and is hiring specialists for training, sales and marketing.

“It’s about building the team, launching our second-generation version of the device, which has some very basic improvements, and then developing this to be a standard of care,” Dewan said.

The startup aims to develop a device that consumers can use outside the doctor’s office and another for children.

SafKan is a portfolio company with the West Coast Consortium for Pediatric Technology and Innovation, an FDA-funded pediatric medical device accelerator.

Diwan, who leads a six-member team, said the brothers were also involved in a health tech accelerator from Dreamit Ventures that helped them learn how to build a medical device company.

Unorthodox Ventures led the first round, with participation from Dreamit Ventures, PCOM (Philadelphia College of Osteopathic Medicine), Primary Care Innovation Fund, Riptide Ventures, Healthtech Capital, Alliance of Angels, and individual investors including clinicians and clients.

In addition to $2.5 million in seed funding and a new $8 million Series A round, the company raised a $2.5 million convertible note in early 2022. Total funding to date is $13 million.

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