The Food and Drug Administration (FDA) has cleared Happiest Baby’s SNOO Smart Sleeper Bassinet plus the SNOO Sleep Sack to facilitate a supine position during sleep for infants up to 6 months of age who are not yet able to roll over consistently.
The marketing authorization was granted based on data indicating that use of the SNOO infant supine sleep system significantly reduced risky sleeping behaviors, including non-supine sleep, bedsharing, and use of soft bedding.
Though the study showed a reduction in sleep behaviors linked to sudden infant death syndrome (SIDS), the evidence was not sufficient to determine whether the device prevents SIDS. According to the FDA, no infant sleep system or positioner has been approved to prevent or reduce the risk of SIDS or sudden unexpected infant death (SUID).
Using continuous, rhythmic sensations, white noise, and swaddling, the SNOO has been shown in a large-scale study to increase the duration and improve the quality of sleep in infants from birth through 6 months when compared with normal cribs and bassinets.
The SNOO Smart Sleeper Bassinet retails for $1695 and can be controlled remotely through a dedicated app that tracks sleep patterns. The system can also be rented.
The SNOO is contraindicated for use in infants who can push up on their hands and knees or for those who have reached 6 months of age, whichever comes first. The maximum weight limit for the product is 25lbs. The device should also not be used if the infant has any condition that would prevent placement in the supine position.
SNOO is granted FDA De Novo approval for keeping sleeping babies safely positioned on the back. News release. Happiest Baby, Inc. April 3, 2023. https://www.prnewswire.com/news-releases/snoo-is-granted-fda-de-novo-approval-for-keeping-sleeping-babies-safely-positioned-on-the-back-301788453.html.