SafKan Health Submits IPO Prospectus for OtoSet, the World’s First FDA-Cleared Automated Ear Cleaning Device

By the sixth month of gestation, the fetal auditory system is fully developed, enabling the fetus to perceive external sounds. In other words, we begin to comprehend the world through sound even before birth.

People often need to have sharp ears and eyes, and be attentive to sounds from all directions; hearing is undoubtedly an important way to understand the world. However, the first World Report on Hearing released by the WHO in 2021 shows that about one-fifth of the global population is affected by hearing problems, making hearing issues the leading cause of disability worldwide.

Text of the WHO World Report on Hearing 

Among these, conductive hearing loss caused by earwax buildup continues to cause harm due to its insidious nature.

In 2019, SafKan Health, a medical device startup headquartered in Tucson, USA, developed the world’s first FDA-cleared clinical automated earwax removal device. The device’s pulsed irrigation and continuous suction capabilities automatically break down and remove excess earwax within 35 seconds. A year later, OtoSet was successfully launched in Belton chain stores, meeting the requirements of hearing healthcare professionals.

Recently, SafKan Health raised $8 million in its Series A financing round, led by Unorthodox Ventures, bringing its total funding to date to $13 million.

The company stated that it intends to use the funds to further expand its business scope and product capabilities. As Sahil Diwan, the company’s CEO, remarked in the press release, “We plan to do for your ears what electric toothbrushes have done for your teeth.”

Earwax buildup is mostly caused by physiological factors such as excessive cerumen secretion and inadequate expulsion, but may also result from pathological conditions like otitis externa and eczema of the external auditory canal. However, earwax removal procedures have seen little innovation in the past. The use of cotton swabs, traditional ear picks, and other tools not only yields limited efficacy but can also injure the ear canal if used improperly, stimulating further cerumen production and leading to increased earwax accumulation.

The American Academy of Otolaryngology states that in the United States, one in ten children suffers from hearing impairment due to excessive earwax. This phenomenon is even more pronounced among adults, with over one-third of the elderly population affected by earwax-related issues. A survey report from Harvard University also indicates that earwax has become a leading cause of conductive hearing loss.

Currently, a significant portion of the American population is affected by earwax, which has become a leading cause of conductive hearing loss. In addition to hearing impairment, earwax buildup is highly likely to cause ear pain and itching, potentially leading to symptoms such as vertigo. Among damaged hearing aids sent for repair, approximately 60–70% suffer from functional failure due to earwax blockage or degradation caused by organic materials.

To this end, SafKan Health has developed the Otoset automated ear cleaning device, designed to provide a more convenient, hygienic, and effective option for earwax removal.

Aadil Diwan, Co-founder and Chief Technology Officer of SafKan Health, suffered from earwax buildup as a child, requiring regular visits to a designated hospital for physician-administered ear injections—a process he recalls typically lasting 30 minutes.

After becoming a biomedical engineer himself, he set out to improve ear cleaning procedures. In collaboration with the CEO of SafKan Health, they envisioned achieving effective ear cleaning by combining pulsed irrigation with micro-suction. Building on this concept, they imagined the product as a device that, like headphones, could be worn to enable automated cleaning.

In 2019, SafKan Health’s unconventional concept of an ear-cleaning headphone won the “Cool Idea” award from Proflabs, securing the seed funding needed to transform the concept into a product. To achieve this, Aadil and Sahil leveraged their Formlabs Form 2 and Protolabs’ 3D Systems 3D printers to validate their design, prototyping the ear pads, housing, and four containers for holding solution and waste using ABS-like materials. Sharp components were printed in soft materials, while the top headband was CNC-machined from ABS to enhance its strength.

Sahil explained, “Since it is difficult to confirm the exact location of earwax within the ear canal, using a syringe for earwax removal is not very effective. Meanwhile, the jet stream directly ejected toward the eardrum also has a high probability of causing complications. We wanted to eliminate those major risk factors, so we designed this pair of headphones. We can be considered experts in ear cleaning because we have devoted all our research efforts to the design of the in-ear component, studying how to produce firmware that combines continuous suction with pulsed irrigation.”

OtoSet resembles a pair of over-ear headphones and incorporates pulsed irrigation and continuous suction technologies. It is equipped with disposable silicone nozzles that spray cleaning solution onto the inner walls of the ear canal during use, while continuous suction removes the used solution and disintegrated cerumen into a collection container, thereby preventing contamination from splattering earwax.

OtoSet Device Design

The entire cleaning process lasts approximately 35 seconds, with the complete procedure controllable within 5 minutes. Compared to the previous 30-minute duration, this significantly reduces time costs.

SafKan, Inc. stated that the use of OtoSet effectively alleviates hearing impairment caused by conductive blockage. As the first FDA-cleared ear cleaning device, OtoSet rapidly and safely removes mild to severe earwax impaction. Furthermore, OtoSet reduces the need for patient referrals to otolaryngologists, thereby fostering greater trust and enabling the delivery of enhanced services.

OtoSet Device Usage Procedure

Furthermore, the efficacy of cerumen removal is significantly enhanced by the combined action of the irrigation solution and the pulse and suction functions.

In response, Dr. Sapna Patel, an American otolaryngologist, stated, “Even without a microscope, OtoSet can remove earwax in a safer, gentler, and more effective manner.”

Practice has shown that, compared to the 20–30 minutes it takes a skilled otolaryngologist to perform an earwax removal procedure, OtoSet requires less time per treatment, thereby enabling care for a larger patient volume. On a full charge, OtoSet can be used more than 50 times, meaning it can operate reliably throughout an entire day, even in a busy otolaryngology clinic.

Undoubtedly, OtoSet has brought ear care into the 21st century, offering clinicians unprecedented convenience.

In China, although audiology started relatively late, in addition to clinical doctors' earwax removal surgeries, the traditional skill of ear picking has been passed down. This technique originated in the Sichuan region and is gradually being accepted by more and more people. The market is showing a trend of rapid development, gradually growing from an appendage of traditional service industries into an independent consumption scenario.

For Chinese people, ear cleaning has become both an urgent need for improving hearing and a form of enjoyment in healthy living. However, amidst this promising outlook, various industry standardization issues have emerged one after another, casting a shadow over the seemingly booming ear-cleaning industry.

In the fiercely competitive market, the ability of enterprises and investors to make timely and effective market decisions is the key to success. The emergence of OtoSet has effectively addressed the drawbacks in the ear cleaning industry caused by factors such as tools and practitioners. In this blue ocean market, actively embracing technology and creativity may well be a superior approach to solving these challenges.