The OtoSet Revolution: 7 Reasons Why This FDA-Cleared System Is The Future Of Earwax Removal In 2025

The OtoSet Ear Cleaning System has fundamentally redefined professional ear care, moving the process from a messy, time-consuming procedure to an automated, few-minute session, and as of December 15, 2025, it remains the gold standard in clinical cerumen removal technology. Developed by SafKan Health, this groundbreaking device is the world’s first FDA-cleared, automated ear cleaning system, utilizing a unique combination of irrigation and micro-suction to safely and effectively eliminate mild to severe earwax impactions.

This deep-dive review explores the technology, clinical benefits, and why the OtoSet system is rapidly becoming the preferred method for audiologists, primary care physicians, and specialized ear care studios worldwide, offering a superior experience compared to outdated, traditional methods like ear syringing or manual curettage. The system’s efficiency and safety profile address a critical need for the estimated 35 million Americans affected by problematic earwax buildup, a leading cause of temporary hearing loss and discomfort.

The Genesis of OtoSet: SafKan Health and the Diwan Brothers

The innovation behind the OtoSet system stems from the personal experience and entrepreneurial drive of the Diwan brothers, Sahil and Aadil Diwan. SafKan Health was co-founded by Sahil Diwan, the company’s Co-Founder and CEO, and his brother, Aadil Diwan, the CTO and inventor of the device.

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Aadil Diwan conceived the idea after years of frustrating, recurring visits to clinics for his own earwax issues. He recognized the need for a faster, safer, and more convenient alternative to the cumbersome methods then in use, such as traditional ear syringing, which can be messy and often requires multiple appointments.

The result of their work is a wearable, automated device that resembles a pair of over-the-ear headphones. This design is not merely aesthetic; it is central to the device’s functionality, allowing it to perform a complete, bilateral ear cleaning cycle in a matter of minutes.

SafKan Health’s dedication to innovation was recognized early on, including being a winner of the prestigious Hearing Technology Innovator Award™ in 2021, cementing OtoSet’s position as a game-changer in the otolaryngology and general healthcare sectors.

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How the OtoSet System Works: A Technological Breakthrough

The core of the OtoSet’s effectiveness lies in its patented, dual-action technology that combines two historically separate earwax removal techniques: irrigation and micro-suction.

1. Controlled Irrigation for Cerumen Softening

The device initiates a precise, automated cleaning cycle, typically lasting only 20 to 35 seconds per ear. During this cycle, a warm, controlled stream of liquid solution is delivered into the ear canal. Crucially, this flow is directed toward the walls of the ear canal, not the eardrum, minimizing the risk of discomfort or injury.

The solution works to break down and loosen the stubborn cerumen (earwax) buildup, preparing it for removal. This careful, automated delivery is a significant improvement over manual syringing, where pressure and direction can be less consistent.

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2. Continuous Micro-Suction for Mess-Free Removal

Simultaneously with the irrigation, the OtoSet employs continuous micro-suction. This vacuum pressure immediately draws the liquid and the dislodged earwax back out of the ear canal.

The waste is collected in small, disposable waste containers integrated into the device. This closed-loop system ensures the entire process is mess-free, highly sanitary, and significantly more convenient for both the patient and the healthcare provider.

7 Clinical Advantages of Choosing OtoSet Over Traditional Methods

For decades, the standard methods for earwax removal included ear syringing (water irrigation), manual curettage (using a specialized tool), or traditional microsuction. The OtoSet system offers compelling advantages that have led to its rapid adoption in specialized centers like All Ears Ear Care Studios.

• Unmatched Speed and Efficiency: The total procedure time is drastically reduced, often taking only a few minutes compared to 15-20 minutes or longer for manual procedures. This allows healthcare practices to treat more patients and reduce lengthy appointment slots.
• FDA-Cleared Safety Profile: OtoSet is the first automated and FDA-cleared device of its kind for clinical use, providing a high level of assurance regarding its safety and efficacy for adults.
• Treatment of Severe Impaction: It is clinically proven to remove both mild and severe cerumen impactions, which can be challenging for simple irrigation or manual methods alone.
• Reduced Risk of Injury: Unlike cotton swabs (which push wax deeper) or uncontrolled syringing (which can cause vertigo or trauma), the OtoSet's automated, controlled pressure and directed flow minimize the risk of eardrum injury or pushing wax further into the canal.
• Mess-Free Procedure: The integrated disposable ear tips and waste containers capture all liquid and cerumen, eliminating the need for towels, basins, and extensive cleanup associated with traditional water irrigation.
• Improved Patient Experience: The process is generally described by users as smoother and more convenient than traditional methods. The automated nature removes the anxiety often associated with manual tools being inserted into the ear canal.
• Reduced Healthcare Referrals: By enabling primary care providers and audiologists to quickly and effectively address earwax issues in-house, the OtoSet reduces the need for costly and time-consuming referrals to otolaryngologists (ENT specialists).

The Future of Ear Care: Availability and Professional Use in 2025

As of late 2025, the OtoSet Ear Cleaning System remains a professional-grade medical device, meaning it is primarily available through licensed healthcare providers and specialized ear care clinics. It is not a direct-to-consumer product intended for home use, which underscores its clinical nature and the need for trained personnel to operate it effectively.

The device's availability is expanding, with specialized studios like "All Ears Ear Care Studios" offering the treatment in various locations. The cost of an OtoSet session varies depending on the provider and location, but prices for a single professional cleaning often range from approximately $99 to $199, reflecting the advanced technology and the speed of the service provided.

The rise of the OtoSet system signals a major shift in how cerumen management is approached. By automating the process, combining the best of irrigation and suction, and receiving FDA clearance, SafKan Health has successfully created a new standard for safe, efficient, and comfortable earwax removal. For the millions of people who suffer from recurring earwax buildup and its associated symptoms—including hearing loss, ear pain, and tinnitus—the OtoSet represents a significant leap forward in accessible, high-quality ear healthcare.