Masimo has received both US FDA and European CE clearance for its E1 single-patient-use pulse oximetry ear sensor. The ear is often used as an alternative site to measure oxygenation in situations where measurement at the fingertip is impractical, such as when there is excessive patient movement or when perfusion is too low to obtain reliable results.
While traditional fingerclip sensors are often applied to the earlobe, the E1 is attached more securely in the cavum conchae. It promises to give faster detection of oxygen saturation changes during low perfusion, and to avoid cross-contamination risks associated with reusable sensors.
Masimo has started a limited market release of the device.
Press release: Masimo Initiates Limited Market Release of E1, Single-Patient-Use Ear Sensor for Pulse Oximetry Monitoring…
Product page: E1 Ear Sensor…