The Owlet: Fact and Fiction

Everyone is talking about the Owlet Smart Sock right now because of its issues with the US FDA and its drop in the stock market. I’ve always wanted to cover this item, look at the research and provide current information – so I figured now was finally the “right” time.

The Owlets major issue with the FDA is that it claims to be a medical device through its marketing, yet it did not seek or attain FDA approval for this label. The FDA sent them a warning letter and requested that commercial sales be stalled. The company is hoping to work with the FDA to obtain approval and get the sock back on the commercial market.

Lets take a look at the Owlet, the facts and the fiction around it.

Disclaimer: Nothing on this blog is or should be considered medical advice. Please seek medical advice from your trusted healthcare professional.

What is the Owlet Smart Sock?

Right now, if you go to Owlet Baby Care US’s website you will find that there is no information on the sock because of the above issues.

However, the commercial sock is still available in Canada. In short – the sock is a heart rate and oxygenation monitor. The associated app with the sock would send you a notification if there was a drop in oxygen level or heart rate. With this information, it also looks at baby’s sleep. There is a whole FAQ available on their website here on the sock.

What type of studies exist around the Owlet?

A study done by Dangerfield et al. (2017) looked at experience and usage of this product in a large group (47k) of newborns retrospectively. The authors note this is a hotly debated topic (the use of devices like this at home) and has been for many years. Most of the literature they reviewed in their study suggests that, for a device like this that is considered a medical device, the greatest benefit seems to be for high-risk infants and not necessarily healthy, term infants. This is in reference to its use to monitor pulse oximetry and heart rate specifically.

In their study, they found that the device was highly reviewed by parents and encourage further research and development of the sock for potential future benefits specifically in higher risk infants.

Is it accurate?

A more recent study by Anjewierden et al. (2021) looked at the detection of tachyarrhythmias in infants using the sock. They reviewed literature that suggested the accuracy of the sock was good. The results of their study showed that the sock was able to detect tachyarrhythmias quite often, and their sample size was quite large.

Malik and Ehsan (2020) reviewed some other studies which showed that the sock had lower efficacy than has been claimed by the company, and they suggested that more studies are needed before recommending the sock to new parents. They do confirm that there is a place for home monitoring systems like the sock, and mention that the American Academy of Pediatrics also supported this as a consideration for infants who are considered high risk. They do not endorse the use of these systems for SIDS prevention however.

Owlet Baby Care’s Canadian website has a research page as well – however when you click the link on the FAQ it takes you to a non-relevant page on the US website currently. If you look at the US site’s FDA response page you can find the company’s response to the FDA and a few common questions answered. I was unable to find this proposed research page at this time – perhaps because of the FDA involvement it is being revised. We shall see.

Verdict is the jury is out – more studies are needed to confirm the level of accuracy. It seems mixed at the moment.

Is the sock safe?

The company maintains that the sock remains safe and note that the FDA was not addressing a safety issue with them when they sent their warning letter.

One major safety concern that exists with the sock and has occurred with other items that track heart rate/oxygenation in the past (like fitness trackers for example) is redness in the location of the band or in this case, the sock.

The company responds to this concern in their FAQ saying this is a rare occurrence and when it has happened it has been related to improper application of the sock or use of the incorrect size. Their research apparently says that it is not a burn as many media articles have claimed, and this is apparently supported by both paediatricians and dermatologists. More can be read on this at their Support Center here. I know I have personally experienced this with my Fitbit band before – but it has been related to it being too tight. I can’t comment on the sock because I’ve never used or owned it.

Notably, there was a class action suit against the company in 2019 related to these burns as well as other concerns like the sock not detecting issues.

In regards to experts, there isn’t much official comment beyond what I’ve mentioned in the previous section. If you do a search on this topic, there are several news media articles that can be perused – but of course, these are media articles. So this always need to be considered as we read through headlines. As always, I encourage everyone to talk about the use of any device like this with their child’s trusted provider.

Similar to above – we hope for more studies around safety and investigation into reported issues with data that is shared and easily accessible to the public. I don’t like that I have to click through a million links to find just a statement about safety, and not the actual data.

Is there a benefit?

There are studies, many others, that look at home monitoring devices like the sock, in general. Most of them suggest that commercially available products like the Owlet sock may have a potential use in certain populations, but that more research and studies on this specifically are needed. Most studies also seem to suggest that healthcare providers should be both aware of and informed about devices like the sock so they can offer guidance around their use to parents.

This whole topic reminds me a lot of the bed sharing post I just wrote. As care providers, we need to educate parents about the risks of these devices – for example, they are not foolproof, or perfectly accurate. They are not the same as the devices you will see used on your infant in hospital. The sock is not a medical grade device. The sock and similar devices are not for SIDS prevention and you should be following other SIDS prevention guidance.

But, we may also need to look at – why do parents use them? We always need to ask these questions to the population to whom the device applies to (and we won’t get much of an answer from infants!). If we can understand the experiences of parents, as well as the current and accurate data on this commercially available device, then we may be able to provide better guidance.

If parents are using it for reassurance/comfort – can we support this while also keeping parents informed about the risks/considerations for its use? And since I mention this – for many, from anecdotal information I have received and read, the device does offer comfort and reassurance. There are also reports in the studies I’ve mentioned of the device accurately capturing an issue that could then be followed up on by medical professionals. So the potential benefits are there.

My thoughts? I never bought the sock because I fell into the other camp of parents – I was pretty sure this item would give me worse anxiety. I already check our camera religiously, if I had an app that looked at this stuff with my healthy infant, I feel like I would have been constantly checking.

I think it’s got potential – as long as safety concerns/risks are addressed, its use recommendations are outlined, and (unless it is approved by the FDA in the future as a medical device) parents are reminded it is not a medical device.

The truth is – these items will keep coming out whether the medical community likes it or not. Investing time and energy into studying, being involved and improving them may be beneficial for us in the long run – because parents will often use them anyways, as we’ve seen with other items. If safety concerns are ruled out and risks remain low (like a fitness tracker), perhaps we can learn more and counsel appropriately going forward. But it all needs to start with more studies and research in my opinion.

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