What parents need to know about the SNOO and the FDA's Breakthrough Device program.
The sleep deprivation new parents feel is real and can be devastating. Ideally, society would support parents so that they can get the sleep they need by prioritizing paid leave (for both parents) and postpartum support services—but we don't live in an ideal society.
New parents often feel like they are alone in their battle for sleep and long for a secret weapon. The SNOO Smart Sleeper claims to be that secret weapon and uses "gentle rocking with soothing white noise and snug, safe swaddling" to keep babies (and parents) asleep for longer. It has a cult following, a 4-figure price tag and claims to add one to two hours of sleep time, something many parents would pay anything for.
This week the SNOO made headlines when the company announced it has received "FDA Breakthrough Device designation to receive expedited review of SNOO as a device to reduce Sudden Infant Death Syndrome." It sounds promising, and for parents who are on the fence about spending nearly $1,400 on the SNOO (or renting itfor $118 a month) the idea that the SNOO may prevent SIDS could be the deciding factor.
But what exactly is the Breakthrough Device Program and what does this mean for parents? It could mean the SNOO will become a lot more accessible. Here's what parents need to know:
The FDA accepted the SNOO for evaluation in the Breakthrough Device program—what does this mean?
This week the company behind the SNOO, Happiest Baby Inc., announced it received Breakthrough Device designationfrom the U.S Food and Drug Administration (FDA). The Breakthrough Devices Program is a voluntary program makers of medical devices and certain other products can apply to be part of. It means the SNOO will soon be reviewed by the FDA as a potentially life-saving device, and the sleeper could one day be labeled for use in the reduction of SIDS.
Dr. Karp, co-founder and CEO of Happiest Baby tells Motherly, "the FDA has a process of reviewing devices that can be helpful for medical conditions and that process usually takes a year and a half, even up to two years of review and study...But if it's a device that potentially can save lives or reduce a debilitating disease, they recognize that there's a need to expedite that year to do it fast."
According to Dr. Karp, if approved (he stressed that part) the SNOO will be the first SIDS prevention product.
"We are not at all claiming that we reduce SIDS, we have more research that we need to do to be able to be true to that point. Right now we're only saying that we can secure babies to the back just because that's what the swaddle does, it reduces their risk of rolling over and that keeps them in that position. But, once we're approved, if we are approved by the FDA, then, of course, we will be able to make that claim."
Dr. Rachel Y. Moon, the chair of the AAP Task Force on Sudden Infant Death Syndrome tells Motherly that as far as she knows there is no evidence to support that the SNOO saves lives. The AAP wants parents to be extremely cautious about any product claiming to prevent SIDS (which, again, the SNOO is not doing—yet).
This may seem odd to consumers who have seen the SNOO marketed as "the only bed to meet the American Academy of Pediatrics' (AAP) back sleeping recommendation," but it is because the AAP's safe sleep guidelines aren't just about putting baby to sleep on their back (babies slept on their backs in the now recalled Rock n' Play, after all) but about several practices.
According to the AAP,these include making sure babies:
- Sleep alone in their own crib, play yard or bassinet on a firm, flat mattress with a taut sheet" without blankets, pillows, crib bumpers, toys or other objects.
- Sleep on their back every time.
- Sleep in a bassinet, play yard or crib in a parent's room for the first six to 12 months.
- Do not sleep in an adult bed, or on a couch, sofa or armchair.
- Are not swaddled once they shows signs of rolling over.
As Dr. Moon explains on the AAP's Healthy Children website, while "babies should sleep on their backs for all sleep times," the AAP also says that "when your baby looks like he or she is trying to roll over, you should stop swaddling."
The SNOO offers "secure swaddling [which] prevents rolling to an unsafe position during sleep" and the makers of the SNOO dispute the AAP's guidelines around swaddling. In a blog post,Dr. Karp suggests that the AAP's recommendation to stop swaddling as soon as a baby can roll is confusing and contradicts the idea that babies should sleep on their backs at all times.
"The AAP also recommends that babies only sleep on the back during the first 6 months and that they do not sleep in the parents' bed for the first year. That's interesting because swaddling makes it harder for a baby to roll to the side or stomach, and it has been shown to lessen a parent's temptation to bed share. So, when wrapping stops early, achieving these guidelines becomes more challenging," Dr. Karp writes.
The chair of the AAP Task Force on Sudden Infant Death Syndrome does not endorse the SNOO, but the device does have some support from members of the AAP. Motherly received a copy of a letter of support for the SNOO from Dr. Colleen Kraft, the 2018 president, American Academy of Pediatrics.
Dr. Kraft wrote, in part: "I practice in Orange County, California, where many of my new parents have used the SNOO for their infants. Universally, my parents report that they are able to follow the Safe Sleep recommendations. They use the SNOO to keep their infants on their back and find no need to bed share. Their infants sleep longer, wake fewer times, and allow these parents the opportunity to sleep without fear for their baby's safety. I have found that improved parent and infant sleep helps to promote optimal bonding, which is essential for early brain development. In summary, the SNOO is a breakthrough device that could change the outcome for our most vulnerable citizens of the United States, our infants. I support this device that promotes the most fundamental health benefit of safe sleep and the security of a parent knowing that their infant will not succumb to SIDS/SUID."
Making the SNOO more accessible
Dr. Kraft believes the SNOO could "change the outcome for our most vulnerable citizens of the United States," but the babies born to her Orange County patients—many of whom are wealthy enough to purchase or rent a SNOO, or are lucky enough to work for a company that provides them as an employee benefit—are not actually the most vulnerable babies in the United States.
According to the CDC, infant mortality rates are higher than average for those who are Black and also for American Indian, Alaska Natives and Pacific Islanders. The highest rates of infant mortality happen for moms under 20 years old. Research suggests that high rates of discrimination and poverty are factors in why some democratic groups experience higher rates of SIDS.
The good news is, if the SNOO is approved by the FDA as a potentially life-saving device, it could end up in more homes through insurance programs. As Dr. Karp tells Motherly, "the goal was first to be able to create something that's helpful. And then the next goal is to get it into as many people's hands as possible."
Karp explains that more than 50 corporations now provide the SNOO as a benefit for employees, "and then we now rent it for pretty much the cost of a Starbucks coffee. And so in just three years we've gone from a $1,200 baby bed to something you could rent for the cost of coffee a day."
But a daily Starbucks isn't in the budget for many American families—and Karp recognizes that and hopes FDA approval could help those families.
"We hope in the next couple of years that insurance companies will cover it and government agencies will cover it. Then we're now at over 20 hospitals doing studies around the world on this bed. To be able to improve health outcomes so that we can convince companies that they will save money by preventing problems, compared to waiting for the process to happen," he says.
In the meantime, Dr. Moon doesn't want parents who can't afford the SNOO to feel guilty because they can't afford one, as she hasn't seen enough evidence to make it a nursery necessity. "However, if they truly have evidence to support the claims, then the onus is on the company to make this more affordable," she said in a statement to Motherly.
The SNOO keeps babies alseep for longer, but is that safe?
Parents are often asked if their baby is sleeping through the night, but according to Dr. Moon, they shouldn't be. Research from McGill University suggests that most babies don't and that while parents are often encouraged to commit to behavioral interventions for baby, perhaps expectations and supports for parents need to be adjusted instead. Yes, moms need more sleep, but perhaps conversations, community and cultural change should be considered as possible solutions, at least as much as any consumer product is.
Dr. Moon does not endorse the SNOO and suggests that babies wake up frequently because they need to. "The purpose of the SNOO is to keep a baby from waking and crying. A baby has to wake every few hours to feed. Additionally, the likely issue with SIDS is an arousal problem. A product that encourages a baby to sleep for longer periods of time is not physiologically advantageous for either safety or feeding purposes," she tells Motherly.
Dr. Karp says you wouldn't wake up a baby to eat if the baby didn't wake up on their own and does not see a problem with an additional 1-2 hours of sleep. "Some babies just mature their circadian rhythm earlier and SNOO helps them do that," says Karp.
The bottom line on the SNOO's Breakthrough Device designation
Bottom line: As Motherly has previously reported,the CDC says progress on SIDS has stalled, and less than a third of American babies are only put to sleep in the products the American Academy of Pediatrics (AAP) recommends: firm and flat cribs, bassinets, or Pack N' Plays which meet the safety standards of the Consumer Product Safety Commission.
If the SNOO can help parents achieve Back to Sleep (something that understandably feels impossible for many exhausted parents) that is certainly a good thing and we are eagerly awaiting the results of the FDA's Breakthrough Device designation investigation.
If the FDA does find the SNOO makes baby sleep safer than we hope more parents will have access to it and more babies can sleep safe and sound.