FAQs about FDA-Cleared Dream Sock®
The first-of-its-kind FDA-cleared Dream Sock® smart baby monitor offers parents the ultimate peace of mind. Dream Sock provides caregivers with a deeper understanding of their infant’s safety and well-being. Below are some frequently asked questions about our recently FDA-cleared Dream Sock.
How do I get the FDA-cleared experience? Do I need to buy a new Dream Sock?
We are excited to share that you do not need to buy a new Dream Sock if you are a current user. The fully-featured FDA-cleared experience, including Live Health Readings for pulse rate and oxygen level and our new Health Notifications will be rolled out to all existing and new Dream Sock users at no extra cost.
To access FDA-cleared features, a current Dream Sock user can click the “Update Now” button on the home screen of their Dream App. For additional information, please reference this article.
What’s the difference between the previous Dream Sock experience and this new one?
The current Dream Sock experience tracks and displays live pulse rate and oxygen level, and notifies caregivers with a lavender prompt when baby may need them or their sleep quality indicators deviate from the baby’s algorithm. FDA-cleared Dream Sock will track and display Live Health Readings, including pulse rate and oxygen level. Additionally, the FDA clearance includes Owlet’s new Health Notifications, which will notify parents with lights and sounds when their child’s health readings fall outside of preset ranges.
What will my experience be when my child is outside the weight/age restriction?
The new FDA-cleared Dream Sock+Health Notifications experience is for infants ages 1-18 months between 6-30 lbs. If your child is outside of the intended use range, you may continue using the Dream Sock with Health Notifications disabled. This experience provides sleep insights into your child, including a Live Sleep Status, Live Sleep session graph with sleep states, historical sleep tracking and predictive sleep. You will continue to receive yellow, blue and lavender notifications that will let you know if your child is not being monitored or if your child is moving excessively and may need your help falling back to sleep.
What happens if I upgrade to Dream+Health Notifications and my child is already older than 18 months? Can you revert my app back to how it was so I can have live readings and notifications again?
The Dream Sock to the FDA cleared Dream Sock + Health Notifications conversion process provides warning to users about the upgrade process. Dream Sock + Health Notifications is cleared from ages 1-18 months and 6-30 lbs. The conversion cannot be undone. Beginning the upgrade is accepting the acknowledgement and terms of the process. Unfortunately, the conversion cannot be reversed.
Is Dream Sock safe and accurate?
Dream Sock is safe and accurate for meeting its intended use. Achieving this FDA De Novo clearance means Dream Sock was clinically tested and evaluated for SpO2 accuracy across all skin tones (Type I-VI on the Fitzpatrick scale) under motion and non-motion conditions. Dream Sock has been demonstrated to be accurate within +/- 3% of gold-standard arterial blood gas measurements.
Can I use this for my child that is older than 18 months?
The FDA-cleared functionality is intended for use on infants 1-18 months and 6-30 lbs. We hope to expand this age range in the future and will share updates as we have them.
Can we set our own ranges for Dream Sock notifications?
FDA-cleared Dream Sock will notify parents if pulse rate or oxygen saturation level falls outside of preset ranges. The ranges are preset and not adjustable.
Why are the parameters for notifications under 50 BPM or over 220 BPM for pulse rate or below 80% for oxygen saturation level? Seems too low.
The preset ranges for Dream Sock +Health Notifications consider the common conditions possible across the intended user range and the appropriateness of the parameters to minimize nuisance notifications. These parameters have been validated through clinical studies which evaluated the prevalence of clinically actionable notifications. If you have concerns about your infant’s readings, even if they do not approach the set notification limits, please discuss them with your healthcare provider.
Is this covered by insurance?
At the time of availability, Dream Sock will not be covered by insurance but is HSA/FSA eligible. There will be insurance reimbursement options available for BabySat™, our prescription monitor intended for infants that require additional monitoring under the supervision of a medical provider.
What is the difference between Dream Sock and BabySat™?
Dream Sock is the first and only FDA-cleared over-the-counter pulse oximeter for healthy infants. It is intended for use on healthy infants 1-18 months and 6-30 lbs. It features Live Health Readings, including pulse rate and oxygen level and Health Notifications that will notify caregivers with lights and sounds if levels leave preset ranges. Dream Sock pairs with the Owlet Dream App and does not qualify for insurance reimbursement. However, it is HSA/FSA eligible.
BabySat is an FDA-cleared prescription pulse oximeter that is intended for use on infants that require additional monitoring under the supervision of a medical provider. Caregivers receive alerts if levels leave ranges set by the infant’s physician. BabySat pairs with the Owlet Care+ App and does qualify for insurance reimbursement options.