Earwax-removal device heads to market with $8M, FDA clearance and a viral TikTok video
SafKan’s OtoSet device for removing earwax. (SafKan Photo)
The man clicks a button on a device settled on his ears like a giant headphone set. A motor runs. Fluid flows. “It’s weirdly satisfying,” he says in a TikTok video that’s racked up more than 15 million views.
More people might have the same feeling if a Seattle company has its way.
SafKan Health is behind the ear-cleaning device that removes earwax and aims to supplant current clinical approaches to removing built up gunk.
“We want to essentially do for your ears what Sonicare and electric toothbrush companies have done for teeth,” said CEO Sahil Diwan, in an interview with GeekWire.
The startup recently raised $8 million to fuel 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, Aadil Diwan. The following year it won the top prize at a Seattle Angel Conference startup competition.
Back then, the device was only a blueprint, born of Aadil’s problem with earwax. Since he was a child, Aadil has suffered from earwax buildup — one of 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 occur annually in U.S. clinics, according to the American Academy of Otolaryngology. Symptoms include hearing loss, pain, vertigo and tinnitus.
Clinicians typically irrigate the canal with fluid to flush out the wax, which can be time consuming. Another option involves suctioning by a specialist.
The OtoSet, said Sahil Diwan, is faster and easier to use. It uses both irrigation and suctioning to clean the ears and takes only minutes.
SafKan co-founders Sahil Diwan (left) and Aadil Diwan. (SafKan Photos)
The brothers founded the company when Sahil was 26 years old and Aadil was 23 and just finishing his undergraduate degree in bioengineering. Fueled with $2.5 million in seed funding, the small team built prototypes using a 3D printer and tested them in collaboration with a Seattle-area clinical partner.
In 2020, the U.S. Food and Drug Administration cleared the device for use by clinicians through a regulatory pathway that required the startup to show “substantial equivalence” to an existing device’s safety and effectiveness.
“Our substantial equivalence was literally a syringe,” said Diwan.
Diwan added that consumers buy a lot of “gimmicky” products to clean their ears. “You’ll find them on Amazon,” said Diwan. “A lot of crazy stuff.”
Products include tiny spades equipped with miniature cameras, drill-like devices that rotate, and kits for ear candling, which literally involves a candle. Some of the devices are dangerous. In contrast, the OtoSet is the only FDA-cleared device for removing earwax, said Diwan.
The FDA’s insistence on seeing SafKan’s data helped the company make a better product, said Diwan. “Going through that process is rigorous, it takes a lot of time,” he said. “It really makes you button everything up.”
The FDA greenlit the device at the height of the pandemic and so it wasn’t until late 2021 that the company began its soft launch, bringing the device in person to professional conferences.
“We would be the busiest booth, because everybody could see the product and try it themselves,” said Diwan. “It was wild.”
Clinicians have now treated thousands of people with the device, which sells for $1,759 for a “six month bundle” on the company’s website.
In another milestone, SafKan inked a partnership this year with hearing aid maker Beltone, which will offer OtoSet to its providers. Earwax buildup is a major cause of hearing aid damage, said Diwan.
The company has not yet released data publicly, but plans to collect more and publish it this year, which Diwan said is critical for the aim of supplanting current methods in the clinic.
SafKan is now tweaking the design of the device to optimize it for large-scale manufacturing with contractors in India and China, and is hiring training, sales and marketing specialists.
“It’s about building up the team, launching our second-generation version of the device, which has some pretty basic improvements, and then just growing this to be standard of care,” said Diwan.
The startup aims to develop a device that can be used by consumers outside of a clinician’s office and another for children.
SafKan is a portfolio company with the West Coast Consortium for Technology and Innovation in Pediatrics, an FDA-funded pediatric medical device accelerator.
The brothers also took part in a health tech accelerator from Dreamit Ventures that helped them learn how to build a medical device company, said Diwan, who leads a six-member team.
Unorthodox Ventures led the Series A round, with participation from Dreamit Ventures, PCOM (Philadelphia College of Osteopathic Medicine) Primary Care Innovation Fund, Dreamit Ventures, Riptide Ventures, Healthtech Capital, Alliance of Angels, and individual investors including physicians and customers.
In addition to $2.5 million in seed funding and the 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.