We believe that the Otteroo is a safe and useful product. With over 440,000 Otteroos in homes across the world, there have been nearly 9 million safe uses (assuming each household uses it 20 times, but we know many use it much, much more!). 

We also know it’s a life-changing product for many families of infants with special needs, who experience movement with Otteroo in a way they simply never could on land due to their disability. 

While we wish all Otteroos were 100% tear-proof or could never deflate, nothing can be–as you know from your experience with other inflatables, such as tires, basketballs, and air mattresses (which always seem to spring a leak when you’re about to head out camping). 

Babies slipping through Otteroo, due to deflation from a slow leak, can and does happen. And we understand it can be a very scary experience to some parents. 

However, as long as the parent is exercising common water safety, and is within an arm’s reach and can pull their baby from the water, then no harm is done.

This is why we stress the importance of checking for leaks in Otteroo, or any inflatable used in water, before each and every use. 

More importantly, though, we implore parents to be within arm’s reach of their infant at all times while they are in the water – with an Otteroo or not. 

I was petrified of water growing up and never managed to get over my fear. I only “somewhat” learned to swim because Cornell, where I graduated from, had a really old and strange “swim three full laps in an Olympic-sized pool” graduation requirement.

This sparked my interest in creating a product that can help babies foster a love of water.

In our early days, I cold-called a lot of developmental experts and medical doctors at teaching hospitals in and around San Francisco. They all wanted to meet in person! 

They all thought Otteroo was a brilliant idea – a game changer to allow infants to start physical therapy interventions early was often the first lightbulb that went off for them.

There are many studies examining the benefits of aquatic therapy and early interventions. This study (not with Otteroo) concludes that there is a relationship between aquatic exercise, respiratory outcomes and functional activities in water and on land in children with Neuromuscular Disorders. 

We were also excited for Otteroo's potential to kickstart infant development. 

When you think about it, it just makes sense – the earlier your baby is able to experience self-produced locomotion (moving from point A to point B), the sooner their brain is able to start understanding cause and effect. 

A 10-year longitudinal study involving 374 participants concludes that “Infants who were more motorically mature and who explored more actively at 5 months of age achieved higher academic levels as 14-year-olds.”

Please note that we are NOT claiming any benefits until we have more data, but the above are pretty solid reasons to explore further. And we were excited and humbled that many academics agree and were interested in working with us to quantify how Otteroo may be beneficial! 

Here are some of the peer-reviewed studies. 

We have been gratified to see so many families recognize the value of the Otteroo, many reaching out to share their inspiring stories, whether seeing their baby smiling for the first time or seeing their infant, whom they were told could never move, doing “normal” things in water. If you need a pick-me-up, please check them out here. 

Later, we were so humbled and honored to see Otteroo being used in research hospitals like Children’s Hospital of Philadelphia and included in care packages sent to families of infants newly diagnosed with Spinal Muscular Atrophy (SMA). 

• Although both warn of drowning risks, the FDA acknowledges that drowning only happens if the baby is left alone; they are more focused on the potential of neck strain, especially in the special needs population, which we will address further on. 

• CPSC, on the other hand, believes Otteroo is defectively designed because it could deflate if there is a leak. We don’t refute their belief that a baby who wears a deflating Otteroo is at risk of slipping out of the device into the water. However, this would not be fatal if they are closely supervised.

First of all, I would like to extend our sincerest gratitude to our community of parents. They rallied and got the attention of the FDA by emailing their positive Otteroo stories to Jeff Shuren, Director of the Center for Devices and Radiological Health at the FDA, after the Safety Communication came out in June 2022. 

We have had multiple meetings with the FDA, and in our latest with Dr. William Maisel (Chief Medical Officer and Director, Office of Product Evaluation and Quality of the FDA), he clarified the reasoning behind the FDA's statement about neck strain as a possible risk: “...young infants typically lack strength and neck control to fully hold their heads upright. In addition, low muscle tone and prolonged head lag has been associated with infants with certain disabilities.” 

Per the recommendation from Dr. Maisel, we are actively moving forward to discuss the type and extent of evidence necessary to show that Otteroo is safe when used as instructed, and discuss the path forward for Otteroo to be classified as a medical device (in FDA-speak, we will be requesting a pre-submission meeting).  

We are working with a research study design team and plan to present our proposed studies to the FDA. The study endpoints will: 

1. Measure the effectiveness of Otteroo at supporting an infant’s head while in the water.
2. Calculate the force on an infant’s head / neck as a function of their weight (from the neck down) when they are in the water wearing the Otteroo.

We know the weight is miniscule because buoyancy significantly reduces a person’s weight when submerged from the neck down, as reported in a study performed in 1987 which found that with immersion to the C-7 (neck) level, weight bearing was reduced to only 5.9–10% of actual body weight.

In the case of an 11 lb infant, their body weighs at most 1 lb in water (we measured internally with a volunteer), which translates to 4.5 newtons. During a vacuum-assisted vaginal delivery, an infant’s neck must withstand external forces of up to 115 newtons (during each of the 2-3 pulls), which is significantly higher!

But the FDA is all about data, so we must determine what they deem acceptable to prove Otteroo’s safety. 

If you are interested to learn more about Otteroo and its benefits, check out these peer-reviewed studies! Or jump to the heart-warming testimonials that keep us going. 

We have done our best to be completely transparent and work with the CPSC every step of the way from the very beginning.

Unfortunately, a tragic event that occurred in 2017 amplified their fear that parents would leave their infants unattended while in an Otteroo.

In this incident, a mother left her child unattended in a bathtub for an extended period of time. We disagree with the CPSC’s assumption that the Otteroo is responsible. (NOTE: We don’t know if the CPSC believes it was the fault of the Otteroo. They may believe it is the mother’s fault. Either way, a child died and that gets their attention.) The mother in this incident was part of a 2-year police investigation and she changed her story about whether the child was left alone in the tub, in the bath seat, or in the neck float. 

CPSC is apparently convinced that parents will leave their infants unattended in an Otteroo while also believing that because Otteroo carries a risk of deflating, it must be defectively designed.  But no inflatable device can be designed to be 100% leak-proof. We believe that CPSC’s position here would set a precedent that could require virtually all inflatable products to be taken off of the shelves.

Safety has always been our number one priority.

The CPSC has reviewed (and approved) our design, manufacturing and quality assurance plan, warnings and instructions before we launched the second generation of Otteroo classics.

In 2017 – before we started production of our second-generation Otteroo, called the LUMI – we voluntarily shared our design for LUMI with the CPSC because we wanted to be completely transparent. 

Moreover, we have been providing documentation on all incidents of slip-throughs since 2015 including interviews with the parents. We have always voluntarily provided this information to the CPSC when requested.

Most slip-through cases have come to our attention when the parent reaches out with a replacement request. We believe that parents tend to not be alarmed by the slip-through because 1) it is sufficiently warned about, and 2) a baby slipping into the water isn’t only possible with Otteroo; babies can slip out of bath seats, hands, etc. However, as long as the parent is with their child and attentive, no harm is done and the baby is pulled out of the water almost instantaneously. (Though, as noted earlier, we do understand for some, seeing their baby slip out of a neck float is a scary experience.) 

CPSC attempted to interview every single parent on the list we provided them. These interviews, which we were sent and reviewed, confirmed that all parents were within arm’s reach when it happened.* We believe that this proves that our warnings worked. 

*NOTE: The family of the infant who tragically drowned never reached out to us directly. We were not able to identify who they were until 2022 when a redacted report became available and out of respect, we have never attempted to reach out to them. 

The very first thing I did when I was contemplating starting Otteroo was to find a lawyer who specializes in product liability to make sure that there was a way to clearly write the instructions and warnings to ensure parents know how to safely use Otteroo. I knew this was of paramount importance, given that it was 1) a baby product, and 2) one used in water! 

While we understand that the CPSC believes that, in some situations, a product cannot rely on its warnings for its safe use, we don’t believe it is a realistic position.  

We believe warnings are essential to ensure safety for innumerable products on the market, including car seats which undergo rigorous testing and are in nearly every household with an infant. 

Yet, no matter how safe a product is made, tragic events can happen–even in CPSC-approved products like car seats and cribs.

According to the American Academy of Pediatrics, a “10-year study of 11,779 infant sleep-related deaths showed that 348 babies died in sitting devices, in most cases while in car seats. More than 90% of the time, the car seats were not being used as directed. The median age at death was 2 months.” 

This is heartbreakingly tragic, but it also highlights the importance of education no matter how much we think something is common sense. 

Will neck floats completely go away if Otteroo didn’t exist?

No, because it is really easy to sell products online, and it is even easier to remain anonymous and untraceable. There are many sellers producing cheap versions of neck floats, often with no warning and instructions, or ones written in a different language. 

The fact is, Otteroo is the only responsible seller of neck floats in the U.S. 

We know from our interviews with parents that despite warnings from the FDA and the CPSC, Otteroo’s benefits outweigh the potential drowning risk, which can be easily mitigated by close and constant supervision.

So if Otteroo is not an option, people will still have access to inferior, dangerous neck floats. Regulating these sellers is a never ending game of whack a mole; they might go away but others pop up almost immediately. 

In CPSC’s history of attempting to remove products they perceive as unsafe, they have reversed some decisions and instead collaborated with the industry to come up with better safety standards because consumers don’t want to part ways with the product category. These categories include ATVs, button batteries, and baby slings. 

With these products, the CPSC has chosen to establish safety standards that manufacturers and sellers must comply with. If the product doesn’t comply, then the manufacturer will be required to recall the product. There are no safety standards for neck floats. We would welcome them.

That’s what our ultimate hope is – to have a productive conversation with CPSC because we both share the same goal: to keep babies safe.

We are hoping they will open the communication channel with us!

However, the issue is not the product which we believe is as safe as any inflatable can be – it’s more broadly water safety education. 

Drowning in the bath will not go away unless we better educate the parents and caregivers about the importance of ALWAYS supervising children while in and near water. 

In CPSC’s own research titled Submersions Related to Non-Pool and Non-Spa Products 2012, they concluded that most non-pool and non-spa related submersions happened during lack of supervision, during bath time, with bathtub or showers being the most usual product. 

We want to work with the CPSC to issue a joint statement (like this joint press release) to emphasize the importance of water safety, especially during bath time.

Stepping away for “just a second” is one second too long. 

If what you have read resonates with you, please buy an Otteroo or tell a friend to buy an Otteroo.

If you want to let the CPSC and FDA know how Otteroo has made a positive impact, please share it here and we will pass it along.

If you have more you can offer (i.e. knowledge on how to work with the FDA, credentials to conduct studies using Otteroo, money to help us pay for our legal bills), please write me at tiffany@otteroo.com.