OtoSet Automatic Ear Cleaning Device FDA Cleared
OtoSet Automatic Ear Cleaning Device FDA Cleared

SafKan Health, a firm based in Tucson, Arizona, won FDA clearance and is about to release its OtoSet automated ear cleaning system.

Designed to address impacted earwax, which affects millions of people and often causes hearing loss, the OtoSet is a pair of headphones with irrigation and suction tips on the inside. These spray water onto the walls of the ear canal, rather than directly toward the ear drum, and suck out the residue at the same time. The residue is collected into a built-in container that is disposable and is replaced, along with the spray tips, with a brand new one between each patient. Alcohol wipes are then used to wipe down the rest of the device to maintain hygienic standards.

SafKan claims that in clinical studies their device was able to remove even severe earwax impactions and considering that each treatment takes less than five minutes, a lot of ears can be cleansed by the OtoSet. More than 50 procedures can be performed on a single charge of the built-in battery, meaning that it should be able to function reliably for a whole day at a busy otolaryngology clinic.

Currently, it takes about 20 minutes for an otolaryngologist, using a microscope, to clean out a well-plugged ear, compared to 5 minutes using the OtoSet. “As an otolaryngologist, we deal with some difficult earwax impactions, and realizing the value OtoSetTM would have in allowing others to clean out earwax in a safe and gentle manner without the need for a microscope is profound,” said Dr. Sapna Patel, an otolaryngologist at Kaiser, in a SafKan press release.

The manufacturer of the OtoSet also plans to release a consumer version of their ear cleaner, allowing people to properly and safely clean the ears at home, similar to how we brush our own teeth without relying on dentists.

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