Masimo announced FDA 510(k) clearance, CE Mark, and limited market release of the industry's first single-patient-use ear sensor. Compared to digit sensors, the Masimo E1 enables faster detection of oxygen saturation changes during low perfusion due to a variety of clinical factors, including sedative or medication-induced vasoconstriction. Compared to reusable ear sensors, it also avoids cross-contamination risks for patients and reduces the complexity of sensor management for clinicians, including cleaning, storage, and transport. In the limited market release, select clinicians around the world will have the opportunity to use and evaluate the performance and benefits of the E1 sensor.

Due to the signal processing limitations of conventional pulse oximetry during challenging conditions, clinicians often seek alternative monitoring sites on the head. In spite of the established need, available single-patient-use sensors for the head have suffered from unreliability. While Masimo SET Measure-through Motion and Low Perfusion pulse oximetry overcomes the limitations of conventional pulse oximetry and offers reliable true alarm detection and false alarm prevention during challenging conditions, there are still some advantages to monitoring on the head such as faster response to oxygenation changes during low perfusion and the use of an alternative site when the digit is unavailable.

As a single-patient-use ear sensor that is placed securely in the cavum conchae (the deep hollow near the ear canal opening), the E1 allows clinicians to combine Masimo SET performance with a reliable alternative monitoring site while minimizing cross-contamination. This site frees up the patient's hands and is easy-to-access for clinicians. Made of durable soft silicone, it has no moving parts that can entangle in the hair or irritate the skin. In addition to its advantages for faster detection of saturation changes during low perfusion, it also offers an alternative site when other monitoring sites are unavailable due to emergency transport or use by another type of head sensor such as those used for Masimo's SEDLine brain function monitoring.

In addition, by using the cavum conchae as the monitoring site, the E1 avoids the challenges associated with forehead sensors, including known limitations in the presence of venous pulsations and when patients are in a supine or trendelenburg position. When compared to the traditional ear lobe site, the cavum conchae site also offers better perfusion and superior signal quality—enabling improved monitoring performance in a sensor that stays in place more securely.

According to Dr Daniel Davis, a contributor on the design of the E1 ear sensor, Professor of Clinical Emergency Medicine, and director of the UCSD Centre for Resuscitation Science in San Diego, California, “The Masimo E1 ear sensor is an ideal monitoring site solution for multiple clinical applications. With it, signal detection is optimized in low perfusion states (sepsis, haemorrhage, hypothermia) and in the presence of peripheral vascular disease. In my experience, the E1 ear sensor detected hypoxemia up to 2-3 minutes sooner, which is critically important during airway management, resuscitation, and inpatient apnea/hypopnea episodes. Additionally, the ear site is more accessible and offers distinct advantages when traditional peripheral monitoring sites are unavailable due to trauma or injury, are swollen and do not easily fit into a digital sensor, or are inaccessible due to drapes, bandages, and dressings. The E1 also eliminates the need for excess cords making it ideal for ambulatory and general care floor patients because it frees up their hands for better mobility, physical therapy, or exercise.”

Masimo is the global leader in innovative non-invasive monitoring technologies that significantly improve patient care—helping solve “unsolvable” problems.