Johari Digital Healthcare is glad to support SafKan Health as a development and manufacturing partner for OtoSet®, the first automated and FDA-cleared ear cleaning device for clinical use. At the push of a button, irrigation and micro-suction technology combine to automatically break down and remove impacted earwax for a quick, safe, effective, and mess-free procedure. OtoSet® often reduces the conventional earwax cleaning procedure time of 20-30 minutes to less than 5 minutes. This new medical technology allows providers to successfully treat a far greater number of patients, increasing access to care for all. Since the soft launch in 2022, this revolutionary device has created a massive impact in the hearing healthcare field in USA and other parts of the world.
The global cerumen removal market size was valued at USD 2.0 billion in 2021 and is projected to expand at a compound annual growth rate (CAGR) of 7.2 % from 2022 to 2030. SafKan Health’s OtoSet® Ear Cleaning System will contribute significantly to this predicted growth.
As Aadil Diwan, Co-Founder & CTO, Safkan Health and his team began researching and developing OtoSet®, they learned the true scale of this problem and how frustrating today’s earwax removal procedure is for both patients and healthcare professionals.
More than 35 million Americans and over 500 million people worldwide are affected by impacted earwax, which is the leading cause of conductive hearing loss. Other symptoms can include pain, vertigo, tinnitus, itching, and coughing. Additionally, approximately 60-70% of all damaged hearing aids sent in for repair are simply clogged with earwax or degraded by organic materials. The earwax removal procedure is very common but has seen little innovation over the last 200 years. This has left healthcare professionals with time-consuming, messy, and antiquated options to provide relief to their patients — until now. OtoSet® is the first automated and FDA-cleared ear cleaning device for clinical use, which is available to healthcare professionals now. SafKan Health has also started developing a consumer version for home use!
While manufacturing the innovative ear cleaning device the team makes sure that they don’t only build a device that fits the specifications, but a device that also serves the greater end goal of higher accessibility to hearing healthcare. Johari’s key focus areas while working with the SafKan Health team are:
Engineering & Design Optimization
Supply Chain Management & Cost Optimization
Final Assembly Production & Testing
The device looks like a pair of headphones with specially designed single patient use ear tips and solution containers. Automated irrigation directed at the walls of the ear canal through the top of the ear tips dislodge and breakdown earwax while continuous micro-suction removes all outflow through the bottom of the ear tips and into the single patient use waste container. Each automated ear cleaning cycle lasts only 30 seconds. Depending on the level of cerumen impaction, softening and multiple cycles may be required.
Reduces procedure time from 20-30 minutes to less than 5 minutes.
FDA Cleared technology safely directs liquid flow towards the ear canal walls.
Clinically proven to remove mild to severe earwax impactions.
Automated suction collects all outflow solution and earwax into disposable waste containers.
As SafKan Health’s OtoSet® Ear Cleaning System continues to help patients and providers across the globe, the developers are working on new generations of the clinical device as well as a direct-to-consumer device for home use. JDHL is really excited about what lies ahead for SafKan Health and looks forward to transforming hearing healthcare together.