The first baby monitor, known as the Zenith Radio Nurse, was invented in 1937. But baby monitors didn’t become mainstream until the 1990s, when frequency hopping technology made baby monitors much more reliable. Since then, expectant parents have poured much time and energy into determining which monitoring product can offer some peace of mind during naps and nighttime. These days, digital monitors with HD cameras, precision audio, and smartphone connectivity help parents relax during those precious hours when baby finally sleeps.

The newly launched Owlet Dream Sock takes infant monitoring into the realm of wearable sleep tracking. Affixed with a small, circular sensor, the soft sock resembles a tiny ankle brace. It wraps comfortably around the baby’s foot, monitoring sleep status, wakings, heart rate, and movement. Via a companion app, parents can check the room temperature, noise levels, and humidity, and track sleep history and sleep quality. Dream Duo adds the Owlet Cam to the platform, so parents can see and hear their baby within the Owlet system.

The app also provides guidance to improve baby’s sleep: a goal that has spawned many books, techniques, and heated debates over the years. It’s easy to feel skeptical about this feature. Still, for the sake of exhausted parents everywhere, we should probably hold out hope that advanced AI can bring about a non-controversial infant sleep solution.

But Owlet Baby Care, Inc. has itself experienced some recent controversy. The company introduced the Dream Sock after discontinuing its first product, the Owlet Smart Sock. Owlet stopped selling the Smart Sock in response to an October 1, 2021 FDA warning letter informing the company that selling the Smart Sock violated federal regulations. According to the FDA, the Smart Sock qualified as a medical device, yet it had not received the required FDA clearance to enter the U.S. market legally. 

Although the FDA letter didn’t mention any specific safety concerns, it cited Smart Sock’s “proactive notifications via lights and sounds if your baby’s oxygen level or heart rate leave preset zones.” Such notifications are considered diagnostic and fall outside the classification for low-risk trackers designed to promote a healthy lifestyle. The new Dream Sock does qualify as a low-risk device as it only sends notifications when the baby is awake, unable to sleep soundly, or appears to be uncomfortable.

Owlet released a statement in February 2022 explaining that the company is working with the FDA and will apply for medical device clearance before reinstating those features. The statement points out that the FDA has not suggested that consumers using the Smart Sock should return or exchange their devices. In an initial response to the FDA letter dated October 4, 2021, Owlet states that results from 3rd-party studies have successfully demonstrated the safety of the Smart Sock. According to this notice, in a survey of 5000 parents, 94% percent reported that the Smart Sock promoted better sleep. 

There’s a dark side to baby monitoring, in that these devices were invented to help prevent unbearable tragedy. Zenith developed the Radio Nurse in response to the 1932 kidnapping of Charles Lindberg’s infant son. Since the 90s, parents have understandably turned to baby monitors out of concern about Sudden Infant Death Syndrome (SIDS) and other conditions that contribute to infant morbidity. But the truth is that even the fanciest and most expensive monitors cannot guarantee the safety of a sleeping baby. Dream Sock and other innovative solutions may enhance digital monitoring and provide useful insights. However, consumers should always do their due diligence and maintain realistic expectations about the benefits of using a baby monitor.