The Owlet Smart Sock 3 differs in several ways from the FDA-approved Owlet Dream Sock. In response to the FDA’s warning letter to Owlet in late 2022, the company took steps to transition from the legacy Sock to the Dream Sock. This transition was prompted by the FDA’s assertion that Owlet’s monitoring of oxygen concentration and heart rate classifies it as a medical device.
The change from Sock 3 to Dream Sock:
The FDA crackdown resulted in a notable alteration in how Owlet presents vital signs data on its app. Interestingly, this change underwent significant refinement in both 2022 and 2023. Furthermore, a recent update in 2024 has brought the Dream Sock even closer to the reporting capabilities of the Owlet Sock 3.
Following the FDA’s ruling that heart rate and oxygen level saturation are considered medical diagnostic information, Owlet made a strategic shift in how these metrics are presented. Instead of simply conveying them as standalone measurements, Owlet incorporated them into sleep quality indicators. This clever adaptation not only gained FDA approval for the continued sale of the Sock but also showcased Owlet’s ingenuity.
Owlet didn’t make any adjustments to the Sock design. Surprisingly, the Dream Sock appears to be a replica of the Sock V3, complete with the same strap that wraps around the ankle using velcro. It still relies on the base station and smart sensor, utilizing UV light and pulse oximetry to diligently monitor the baby’s vital signs.
Owlet Smart Sock Vs Dream Sock: 5 Key Differences:
Vital Signs Metrics Are Now Sleep Quality Indicators:
Owlet has integrated its metrics reporting system with sleep quality indicators and sleep solution metrics. This innovative approach combines various Sleep Quality Indicators, such as movement, heart rate, oxygen level, and wakings, to accurately assess your child’s sleep state and overall sleep quality.
If your child is uncomfortable or needs assistance to sleep more soundly, the system will promptly notify you. While the sock continues to monitor vital signs, it now utilizes them as indicators of sleep state and quality. By opening the new Dream app while the sock is on, you can conveniently access these indicators, along with real-time movement patterns and reported wake-ups.
Live Reporting Changed to a 10-minute-Average Reporting:
Between early 2022 and October 2023, the Dream Sock app transitioned from Owlet Sock 3′ live oxygen level notifications to notifications of 10-minute averages. Rather than showing second-by-second readings as it did with Sock 3, it displayed a 10-minute historical average.
While the app could still instantly alert you if oxygen levels go out of range, low oxygen levels trigger an alert for “poor sleep quality” instead. This is because the app tracks oxygen levels as part of its multifactorial sleep algorithm. If oxygen levels are abnormally low, the app reports suboptimal sleep quality and triggers a lavender alert on your base station and phone. Despite the 10-minute average, the alert is instantaneous, not delayed by 10 minutes.
Starting in November 2024, Owlet introduced an exciting update to the home screen feature. The oxygen level, displayed as a 10-minute average is now available on the home app, similar to Sock 3 dashboard but still showing 10-minute averages.
Sleep Comfort Metrics:
Rather than reporting oxygen level saturation and heart rate as part of a baby’s vital signs as it did in Owlet Sock 3, Dream Sock reports these two metrics along with movement and waking times to give an aggregate score for your baby’s sleep quality and comfort.
Dream Sock has therefore transitioned to provide something similar to Nanit’s sleep insight where it uses a combination of sleep quality indicators to guide you on your baby’s well-being. Dream Sock will send a sleep-assist prompt if the baby is feeling uncomfortable or requires assistance to achieve a more restful sleep. This is determined by monitoring sleep indicators such as oxygen and heart rate and comparing them to the baby’s baseline. If the baseline for sleep quality shows that your oxygen level has dropped, you’ll get a notification for poor sleep quality and will have to check on specific data to guide your response.
In Dream Sock, sleep quality indicators include the historical average of oxygen levels. However, unlike Owlet Sock 3, there is currently no oxygen chart available in the sleep session history, which displays historical charts and data on oxygen level concentrations.
Unlike the Smart Sock 3, the Dream Sock has obtained FDA De Novo clearance. This signifies that the Dream Sock underwent comprehensive clinical testing and evaluation for SpO2 accuracy across all skin tones (Type I-VI on the Fitzpatrick scale) under both motion and non-motion conditions. The Dream Sock has proven to be accurate within +/- 3% of gold-standard arterial blood gas measurements. In contrast, the Owlet Smart Sock 3 did not have FDA clearance. It is also FSA and HSA-approved.
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Sandra W. Bullock is a highly skilled expert in baby safety, specializing in both indoor and outdoor safety. With her previous experience in retail support, she has successfully assisted numerous parents in installing essential safety equipment such as baby gates, cabinet locks, and outlet covers. Additionally, Sandra has collaborated with various child care facilities, providing valuable safety consultations and comprehensive training to caregivers.