When we launched the Owlet Smart Sock—a consumer device which contained a wireless, bluetooth pulse-oximeter at a fraction of the size and a tenth of the cost of a traditional pulse oximeter device—people were skeptical. They wanted to know if they could trust the accuracy of the Owlet Smart Sock.
Since its development, Owlet has conducted several third-party studies to validate its accuracy; two of which are of special value because they tested the Smart Sock sensor against the highest standards. In both studies, the Owlet Smart Sock has performed exceptionally well and has met industry and regulatory standards for accuracy for pulse oximetry.
The first study used direct arterial blood gas measurements, which is the “gold standard” for testing accuracy of pulse oximeters. The sensor performed well within required standards for pulse oximetry. The Owlet accuracy study on ClinicalTrials.gov can be found here.
The second study tested our accuracy in 15 babies between 0 and 17 months of age against Masimo Radical-7 oximeter, an FDA-approved medical device. The results of the tests showed the Smart Sock sensor reached desired industry accuracy standards and compared favorably to Masimo Radical-7.
The testing validates what hundreds of thousands of parents already know: the Owlet Smart Sock is accurate and can be trusted.
Summary of the study results can be found in the table below.
Table: Owlet Smart Sock V2 Sensor Accuracy Studies
* Accuracy Root Mean Square (ARMS) evaluates the accuracy of pulse oximetry. It is required to be 3% (SpO2 range 70-100% in non-motion conditions)
Owlet is helping shift thinking (and data) into everyday lives.
From day one, the accuracy of the Owlet Smart Sock has been one of our top priorities. We believe by empowering parents with the wellness insights of heart rate, oxygen levels and sleep, they can take a proactive role in their baby’s well-being and development.
To ensure you have the best experience possible using the Owlet Smart Sock, we recommend keeping these guidelines in mind:
- Change the sock size as your baby grows
- Only wear while your baby is asleep
- Do not use on an awake or moving baby
- Follow Safe Sleep Guidelines
- Do not use while co-sleeping
- Always activate the Base Station
- Make sure your baby is dressed appropriately for the sleeping environment