The Food and Drug Administration has approved the first “smart bassinet” whose manufacturer says it reduces safety risks for infants through automated rocking that keeps them flat on their backs.
Happiest Baby, Inc.’s SNOO Smart Sleeper, an over-the-counter sleep system that parents can control and monitor on their smart devices, sells for $1,695. The device includes a “sleep sack” that swaddles babies up to 6 months old who are not able to roll over consistently.
That design allows the Los Angeles-based manufacturer to market the device as the only crib that “keeps your baby safely on the back” and uses “the #1 safe sleep guideline recommended by the American Academy of Pediatrics.”
The FDA approved the device this month as providing “reasonable assurance of safety and effectiveness for the intended use,” noting it as the first legally marketed smart crib, a spokesperson for the federal agency said in an email.
However, the spokesperson added that the FDA’s review of incidents of Sudden Infant Death Syndrome (SIDS) in SNOO users vs. non-SNOO users was “not sufficient” to prove that the device is more effective than ordinary cradles at keeping babies safe.
Babies rolling over onto their faces and suffocating during sleep is the most common cause of SIDS — also known as Sudden Unexpected Infant Death, or SUID.
According to federal safety guidelines, parents can protect their babies by clearing suffocation hazards like large plush toys out of any crib.
“At this time, there are no infant sleep systems or infant positioners authorized for marketing by the FDA to prevent or reduce the risk of SIDS/SUID,” the FDA spokesperson told The Washington Times. “The American Academy of Pediatrics and the National Institute of Child Health and Human Development recommend that the best way to reduce the chance of SIDS/SUID is to create a safe sleep environment for a baby.”
The agency has approved the SNOO Smart Sleeper as a Class II medical device, meaning it carries a medium risk to users.
Pediatrician Harvey Karp, who worked with an MIT engineer to create the SNOO, said he got the idea from 20 years of teaching pregnancy class instructors how to help exhausted parents calm their crying babies at night. The SNOO was designed to promote sleep through gentle rocking and soothing.
He said that no matter how many lessons he taught at hospitals, military bases and teen pregnancy programs, 3,500 babies kept dying annually from SIDS.
“I thought, if another country killed 3,500 of our babies every year, we would stop at nothing to save their lives,” Dr. Karp told The Times. “Yet the government programs were not giving us the progress we needed.”
Six museums have exhibited the SNOO, including the permanent collection of the Smithsonian Institution, and Dr. Karp said more than 150 hospitals use the device for 4-5 hours a day to relieve nursing staff shortages in maternity wards.
Weary parents of newborns have coveted the SNOO since it first hit the market in 2016, but more for sleep reasons than safety.
Moms have raved in online discussion forums that it saves them from getting up every few minutes at night by emitting white noise sounds that lull their babies back to sleep.
Several cheaper knockoffs have appeared online at Amazon, where the SNOO ranks in the top 100 of best-selling bassinets but draws criticism from some parents for the high sticker price of an item their children will only use for six months.
“$1299? Seriously? Given it becomes a glorified bassinet after 5 months when babies can start to roll over, I’d expect an extra kidney at that price,” one parent named Devin wrote in an October 2019 Amazon review.
“Our baby was in a standard bassinet for a couple weeks but I was up all night replacing the binky and not getting any sleep,” a mom named Amber wrote in another Amazon review dated Feb. 19. “Now when his binky falls out SNOO is there to sooth[e] him back to sleep without it.”
• Sean Salai can be reached at ssalai@washingtontimes.com.