The Food and Drug Administration (FDA) has granted 510(k) clearance to OtoSetTM – Ear Cleaning System (SafKan Health) to remove impacted earwax.

OtoSet is an automated ear cleaning device that resembles a set of headphones. The device breaks down earwax by using irrigation directed from solution containers through disposable ear tips and toward the walls of the ear canals. Continuous microsuction then draws the liquid and earwax back through the ear tips and into disposable waste containers.

The device provides at least 50 earwax removal procedures per battery charge. Both bilateral and unilateral procedures can be performed with a total procedure time of under 5 minutes. OtoSet is expected to be available in late 2020.

“As an educator of primary care physicians, I can envision physicians of the future using OtoSet as an essential tool in patient care,” said Dr Gary Kato, a primary care physician affiliated with the University of Washington Medicine.

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A consumer version of OtoSet is also in the works, according to Sahil Diwan, co-founder and CEO of SafKan Health.

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  1. New FDA cleared automated ear cleaning device brings ear care into the 21st century. [press release]. Seattle, WA: SafKan Health; November 12, 2020. 
  2. SafKan Health website. Accessed November 12, 2020.