“The Owlet Smart Sock is a Bluetooth Pulse-oximeter, which means that it measures the amount of oxygen in the blood. The goal is to protect babies while they sleep and reduce the risk of SIDS [sudden infant death syndrome] or suffocation,” explains Elizabeth King, founder and CEO of Sleep Baby Consulting. The device also monitors the baby’s heart rate and can send the information to an app on your phone. The FDA sent a letter to the Smart Sock’s manufacturer, Owlet Baby Care, on October 5, 2021, stating that the company has been “marketing Owlet Smart Socks in the United States without marketing clearance or approval” from the FDA. Owlet then pulled the product from the market and says it will apply for the appropriate approvals. But plenty of parents say they aren’t concerned with marketing the socks as a medical device. Instead, they’re concerned with how the device has helped keep their child safe, and they want it to stay on the market. Here we’ll take a look at how the Owlet Smart Sock works, the FDA’s request that the socks be marketed as a medical device, and how parents either adore the smart socks or can do without them.
How the Owlet Smart Socks Work
The smart sock is designed to monitor the baby’s levels in a way that is not intrusive, by using clothing the child normally wears. “The baby wears a sock that has a sensor that reads oxygen and heart rate levels. If those levels fall below preset ‘safe’ zones, an alarm goes off on the base station that the sock is connected to,” states Nichole Levy, a certified child sleep expert at Little Peach Sleep. The ability for parents to monitor their babies’ breathing while they sleep can help remove a level of stress, and some parents say it can help reduce the risk of SIDS. SIDS occurs when babies unexpectedly stop breathing during their sleep. In 2019, almost 40% of sudden unexpected infant deaths were caused by SIDS. Stay-at-home mom Julia Garza started using the Owlet when her son was 2 months old. “I knew male infants had a higher rate of SIDS, and my husband and I have always looked for ways we can reduce the risk,” she states. “The Owlet seemed like another tool we could use to keep our infant safe since it would alert us if he was having trouble breathing.” Those alerts and that monitoring, however, are what make the Owlet function like a medical device. And that’s what caused concern for the FDA.
FDA Concerns
Medical devices must have FDA approval to be marketed in the United States. That clearance can assure the appropriate level of oversight. “A medical product is subject to a rigorous evaluation by the FDA and its group of physicians, who carefully review safety and efficacy data that the company must provide to the FDA,” states Armeen Poor, MD, a pulmonary attending physician at Metropolitan Hospital in New York. “This ensures that products that are out there to be used do not cause any harm and are true to what they are marketing." Because Owlet did not have FDA authorization, the company pulled the product off the market. The company says it will now seek FDA approval. The company notes that smart sock was not recalled and that the FDA did not cite any safety concerns or reported safety issues from thedevice’s usage. “My concern with this device is that studies have shown that parents are more willing to engage in unsafe sleep activities like letting their child sleep on their stomach or with blankets in the crib if they feel the device will alert them to any problems. Even with assurances from a device like this, parents still should be practicing safe sleep to reduce the risk of SIDS or any other injuries in the crib,” states King. Although the smart socks will no longer be sold, parents who already have the item can continue using it. For some parents, however, lack of access to a much-loved item is cause for action.
Some Parents Love It, Others Wonder What the Big Deal Is
News of the Owlet Smart Sock being taken off the market sparked the ire of parents dedicated to the device. An online petition with the goal of keeping the smart sock on the market has garnered over 150,000 signatures so far. Parents like Sara Beth Berman understand why. She started using the smart sock on her daughter just a few days after she was born, and loves it. “I called it the baby Fitbit, and it was the best for telling me her sleep schedule. I could literally see the moment she dropped off to sleep because her heart rate would drop as her breathing slowed into little sleep snores,” Berman states. Garza says when she dealt with postpartum anxiety, her fears were quelled by the use of the Owlet Smart Sock. “I could open the Owlet app and check on my son without having to creep into his room and hold my hand near his nose to see if he was breathing,” she states. “The data on the app was reassuring.” Garza is expecting another boy and wants the product to be available to use with her next child. “We had a great experience with the Owlet and like any product that I’ve used and love, I want to use it again,” she states. On the other hand, problems with increased anxiety are what caused Meredith Riggins to stop using the product. Her daughter spent time in the neonatal intensive care unit (NICU) after being born prematurely. Riggins says alarms sounded when her daughter’s oxygen levels dropped too low in the hospital; she thought the Owlet would do the same thing at home. “I became obsessed with checking her oxygen levels, to the point that I couldn’t sleep myself because I was so worried she wasn’t breathing. Also, on more than one occasion, the alarm sounded and blared red, and it sent me into a panic, only for me to realize it was a ‘false’ alarm and she was fine.” Riggins adds that the NICU nurses advised against using the Owlet. “If this device helps put a new parent at ease, then they should use it. But I think the Owlet needs to be marketed as a medical device before it is allowed to come back,” states Riggins. For author Kimberly Rae Miller, she says as a first-time mom she made an impulse buy to ease her fears of unknowns with a newborn baby. The purchase, however, was not a successful one. “I only used the sock a couple of times. It seemed to irritate my son and even as a newborn…he fussed to get it off.” Experts note that having the product on the market can be positive for consumers, but it’s important to ensure that it’s marketed properly. “I can empathize with parents wanting access to products to help them have even a little peace of mind at nighttime,” Levy notes. “I think it can be a win for all if it can be approved by the FDA and stay on the market for parents to have.” Ultimately, however, no device can take the place of implementing safe sleeping measures with your baby.
Safe Sleep Practices Are Priority Number One
While sleep aids and technology can be a dream to sleep-deprived, worried parents, they have to be balanced with the basics. The American Academy of Pediatrics recommends the following safe sleep guidelines:
For the first year of life, the infant can sleep in the same room with their parents. They should have their own sleeping surface, near their parents’ bed.Make sure your baby is not dressed too warmly for the environment so they don’t overheat.Avoid using devices like sleep wedges or positioners. They are not considered safe for sleeping.Put babies on their backs to sleep.
“As a sleep consultant who advocates for safe sleep, any product that offers monitoring of the baby should not be relied on 100% for safety. We use technology for peace of mind, but if the environment is not safe, there are still risks,” Levy states. Parents love their little ones, and they want to do whatever they can to keep them healthy, happy, and safe. Observing best sleep practices and getting a little help from a product that is safe and effective can be a win-win for all involved. “If a product has a decent chance of alerting me to something potentially harmful, that’s good enough for me,” Garza concludes. Experts caution that while devices like the Smart Sock may help with peace of mind, technology is no replacement for proper sleep safety. Parents should continue to focus on following sleep safe guidelines, ensuring they’re doing all they can personally to keep their little one healthy and happy.
