PoliticsHealth Care


First FDA-cleared automated ear cleaner could become widely used

An FDA-cleared automated ear cleaning system looks like a pair of headphones, and could become a widely used part of more automated health care.
FDA-cleared OtoSet Ear Cleaning System.
Posted at 6:12 AM, Mar 14, 2023

A new type of ear-cleaning device may become more widely offered by health care professionals, especially to those wearing hearing aids. 

Safkan Health, the maker of the first FDA approved automated ear cleaning device OtoSet, says its headset-looking machine will clear "excessive or impacted earwax" from the ear. 

If someone experience a sudden loss of hearing at any time in life, the Mayo Clinic advises people to see a doctor. Especially if it happens in one ear. Gradual buildup of earwax is among the top causes for hearing loss. 

The Mayo Clinic says that the ears are "self-cleaning" for most people, but earwax can become excessive and move deeper into the ear canal.

Health care professionals usually use a small instrument known as a "curette," or a suction device with other specialized methods to remove earwax buildup. 

Sahil Diwan, CEO Safkan Health and co-founder of the company that makes the device says the OtoSet ear cleaning system is for health care professional use only. 

While some have reported on the nearly $3,000 price tag for the device, Diwan wants to make it clear that this product isn't being sold to the general public. So, the price of a visit to a professional to administer use of the ear cleaning system would vary. 

Diwan said the company sold out of their devices in the first three weeks of a launch. He started the company with his brother in 2017 and they have secured patents on the device and received FDA approval. 

OtoSet works by creating a cycle of liquid flow from a container of solution which flows out of disposable ear tips. The liquid is directed to ear canal where it is said to break down earwax before being drawn back through the ear tip by micro-suction to a disposable waste container.

The company has partnered with Beltone to provide an earwax cleaning solution for hearing aid users. 

While there are various products on the market for clearing excess earwax that are sold to consumers directly, online or over the counter in stores, the OtoSet device isn't yet meant to replace cotton swabs or earwax clearing drops. It's also important to note that the National Institutes of Health warn cotton swab users that inserting swabs or other objects into the ear is never advisable as it could damage the ear or push wax deeper into the ear canal. 

Many tech enthusiasts might have become excited about the OtoSet after the release of another headphone-shaped device from Dyson that claimed to purify air while it rests on the user's head, with a $1,000 price tag. That device was sold to consumers, while the OtoSet would be sold to and used by professionals in a doctor's office setting at this stage.