OtoSet® for Audiologists

It is an exciting time to be an audiologist. With sophisticated, smart, and sleek technology available to address hearing loss, you have such powerful and effective options to offer your patients. And it is such a monumental payoff to see the joy your patients experience when, for the first time after years or even decades, they reconnect to the sounds they have been missing.

We understand that the work you do is nothing short of life-changing for the millions of people who experience hearing loss. We also understand that more than 35 million Americans are affected by impacted earwax. In the United States alone, there are an estimated 20 million visits to healthcare professionals for the earwax removal procedure annually.

In your field, you know more than most the effects of impacted earwax on your patients’ hearing. It is, after all, the leading cause of conductive hearing loss. Furthermore, excessive earwax buildup can affect the functionality of these incredible hearing instruments available and is the main reason why hearing aids are damaged and sent in for repair.

Taking into account the correlation between impacted earwax and hearing issues, the team at SafKan Health saw a clear problem. While hearing aid technology has advanced leaps and bounds, earwax removal methods have not evolved much in 200 years.

You may have seen this in your own experience: this lack of innovation has left audiologists with antiquated options for extracting earwax which are time-consuming, risky, and messy. SafKan Health is excited to introduce an innovative new solution: OtoSet® - the first automated and FDA cleared ear cleaning device for clinical use.

Impacted Earwax & Hearing
The American Academy of Otolaryngology estimates that 1 in 10 children, 1 in 20 adults, and one-third of adults 65 and older have excess or impacted earwax.

As an audiologist, you have seen firsthand how earwax accumulation obstructs your patients’ ear canals and creates barriers for speech and sound to be processed. In addition to hearing loss, earwax impaction can cause various uncomfortable symptoms for your patients, such as:

• Tinnitus: a buzzing or ringing noise in the ears
• Pain in the ears, earaches
• Sense of fullness or pressure in the ears
• Dizziness, coughing, itchiness
• Discharge and/or odor from the ears

These symptoms, if left untreated, can impact ear health and contribute to ear-related conditions. Though an accumulation of earwax is such a seemingly simple problem, its removal can be challenging.

Challenges of Earwax Removal
Earwax removal is one of the most common procedures performed by healthcare professionals nationwide. Unfortunately, because the process itself is not standardized, nearly one-third of procedures fail to remove earwax thoroughly and effectively. Much of this is due to outdated earwax removal tools and practices which include:

• 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.
• Irrigation: this method (also referred to as ear syringing) involves manually flushing wax out with a syringe or spray bottle.

These methods require more time and can also be messy in addition to involving the risk of injury. For example, use of manual instruments like a curettes can damage the eardrum or ear canal.

Current earwax removal practices can be inconvenient and inefficient for audiologists and other healthcare professionals. The scope of this problem and the desire to offer an easy solution inspired the team at SafKan Health to develop OtoSet®.

Benefits for Audiologists
OtoSet® brings earwax removal into the 21st century, lining up nicely next to the extraordinary hearing devices available for patients. This device offers numerous benefits for patients, healthcare professionals, and practices. Major benefits include:

• Developed with expertise. OtoSet® is an FDA cleared medical device that was developed with extensive research and expertise from healthcare professionals. 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 professionals.
• 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® is a new medical device for hearing health care, complementing the sophistication of hearing instruments audiologists work with every day. With its precision and ease, OtoSet® can be an essential tool for your patient care, giving you a safe and efficient way to remove the obstacles of earwax on your patients’ life-changing journeys to better hearing.