Tucson-based startup SafKan Health this week announced FDA clearance for its automated ear-cleaning device, OtoSet.
Developed to clean impacted earways, OtoSet has irrigation and microsuction technology built into an automated and wearable device. According to the American Academy of Otolaryngology, excessive or impacted earwax is present in 1 in 10 children, 1 in 20 adults, and more than one-third of the geriatric population. It is also the leading cause of conductive hearing loss, according to a Harvard University report.
SafKan won Protolabs’ 2019 Cool Idea! Award for OtoSet. The headset has disposable silicone nozzles that spray a warm saline solution against the walls of the ear canal while sucking the solution and wax back into the nozzles and disposable outflow containers, avoiding messy spills, the company said.
SafKan Health is now developing a consumer version of the device that can be used to prevent excessive earwax buildup from home.
“We plan to do for your ears what electric toothbrushes have done for your teeth,” said company CEO Sahil Diwan in a news release.