OtoSet® for Healthcare Providers
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OtoSet® for Healthcare Providers

Impacted earwax is among the most common reasons why people visit primary care physicians, otolaryngologists, and audiologists. In fact, in the United States alone, there are an estimated 20 million visits to healthcare providers for the earwax removal procedure annually.

The current most common procedure for removing earwax is ear syringing. Not only can this procedure be time-consuming for such a seemingly simple problem, but it can often be unsuccessful - meaning that millions of patients need to be referred out to high-cost otolaryngologists every year.

This is why the team at SafKan Health developed OtoSet®, the first automated and FDA cleared ear cleaning device. This innovative cleaning system offers an efficient and effective solution for healthcare providers and their patients.

Prevalence of Impacted Earwax
Impacted earwax, an excessive accumulation of earwax in the ear canal, is a major cause of ear-related problems which lead patients to seek medical care. This health issue is more prominent than most people realize. According to the American Academy of Otolaryngology: 1 in 10 children, 1 in 20 adults, and 1 in 3 older adults have excessive or impacted earwax.

This statistic highlights both the prevalence of people dealing with earwax buildup and the prevalence of healthcare provided for it. However, those statistics may not reveal the entire picture. Given that it is common for people to shrug off addressing hearing-related issues, impacted earwax is likely under diagnosed, under treated, and consequently under reported.

Challenges Healthcare Providers Face
Earwax removal procedures have experienced little to no innovations over the last 200 years. Yes, 200 years! Common methods for earwax removal include:
  • Irrigation: this method (also referred to as ear syringing) involves manually flushing wax out with a syringe or spray bottle.
  • Curette: a small medical instrument with a curved shape that is designed to manually pull out the earwax.
  • Suction: micro-suction involves using a microscope and suction device that helps manually extract wax out of the ear.
These methods of extracting earwax can be messy, difficult, and involve risk. For example, manual use of medical instruments like curettes comes with the added risk of injury like eardrum perforation - piercing or tearing the thin tissue that divides the ear canal and middle ear.

The lack of advancements in ear care related to earwax, the amount of time removal procedures take, the scope of people affected, and the prevalence of this service highlights the inconveniences healthcare providers face. After understanding this problem, the SafKan Health team were inspired to address the issues and provide an effective solution that makes earwax removal easy.

What Does OtoSet® Offer?
Healthcare providers did not go through their rigorous education and specialized training to spend so much time removing earwax! OtoSet® provides an innovative solution to a common problem, optimizing the earwax removal procedure. The device offers numerous benefits including:
  • Developed with expertise. OtoSet® is an FDA cleared medical device that was developed with extensive research and expertise from healthcare providers. This included strong collaboration with otolaryngologists who are experts in ear health.
  • Efficiency. Currently, earwax removal procedures can take 20 to 30 minutes compared to just 5 minutes with OtoSet®. Additionally, the device provides the option for bilateral procedures and the battery allows more than 50 patients to be treated on a single charge. This means that OtoSet® is ready to go when it is needed!
  • Effective. In a 30-second cleaning cycle, liquid flow is directed from solution containers through disposable ear tips and towards the walls of the ear canals to break down earwax. Continuous micro-suction draws the earwax and liquid back through the ear tips and into disposable waste containers for a mess-free procedure.
  • Easy to use. OtoSet® was built to be user-friendly to increase access to care. Its design makes the device easy to learn and use. And its automated process means that the procedure is no longer labor intensive for healthcare providers.
  • Reduces risks. The ear tips for OtoSet® direct liquid flow towards the top and bottom of the ear canal rather than at the eardrum. With infection control in mind, OtoSet® takes advantage of single patient use disposable ear tips and waste containers making the device convenient to clean between patient use.
OtoSet® was designed to help bring ear care into the 21st century. This exciting device offers an automated solution for earwax removal, better supporting healthcare providers and the needs of their patients.