Perception of the patch-based polysomnography system and patient-reported experience from using the device were positive. Patients reported that they liked the Onera STS, found it comfortable and that it was simple enough for them to use it unsupervised at home. More than 69% of the patients found the Onera STS comfortable when wearing the four sensors. No patient expressed strong discomfort.
FDA 510k cleared and CE-marked refers to the Onera Sleep Test System, which is a Class IIa medical device. Onera STS includes the Onera STS I System, which is CE marked in Europe, and the Onera STS System, which was cleared the the Food and Drug Administration for use in the United States.