Did the FDA Ban the Owlet Smart Sock Monitor?

Поделиться
HTML-код
  • Опубликовано: 19 окт 2024

Комментарии • 146

  • @Nardes
    @Nardes 2 года назад +70

    We purchased an Owlet for our little one after she had apneic spells while in the hospital. We originally did not think we needed one, but that changed after what transpired in her first 48 hours of life. Safe sleep always was (and still is) the number one priority when she was finally able to come home, but having an Owlet sock and then the Nanit breathing band helped put our anxieties (which we incredibly high after what we had been through at the hostpital and in the NICU) at ease. When she went to bed at night we knew we had done everything we could to keep her safe while sleeping, and these breathing monitors were just the icing on the cake to make sure she was holding up her end of the bargain and kept breathing throughout the night.

    • @dadverb
      @dadverb  2 года назад +3

      Thanks so much for sharing your experience on this.

    • @Mommyingthis
      @Mommyingthis 2 года назад +12

      RN/FNP here. mom of a baby who used it for a year due to various reasons. Looooveeee the owlet! It doesn’t monitor for sids. It monitors heart rate and oxygen levels just like the Apple Watch, which is still on the market. Also, checked it with medical grade pulse oximetry AND used it when our child was admitted to a hospital while on the monitor. For over 2 weeks the owlet MATCHED the hospital monitor and medical grade pulse ox’s. Personally know many NICU AND PICU nurses who says it works great! Maybe fda doesn’t want parents making coorelations between things like example: parents saying vaccines cause sids and monitoring it themselves etc etc. Not quite sure… but as far as it working… IT WORKS!

    • @KristenGullick
      @KristenGullick 2 года назад

      Just home from our nicu stay for the same issue and I’m trying to find what would be best.

  • @annsmith7196
    @annsmith7196 2 года назад +175

    It amazes me the FDA approves e-cigarettes but not something to monitor the heart rate/oxygen of a baby.

    • @GenJenandJuice
      @GenJenandJuice 2 года назад +6

      This!! It’s insane.

    • @joeymdye
      @joeymdye 2 года назад +7

      Obviously, they are going to be more strict about baby products.

    • @annsmith7196
      @annsmith7196 2 года назад +6

      @@joeymdye shouldn’t all health products have equal scrutiny?

    • @OutdoorCanadians
      @OutdoorCanadians 2 года назад +4

      @@annsmith7196 one is for adults who can make their own choices one isn’t

    • @annsmith7196
      @annsmith7196 2 года назад +6

      @@OutdoorCanadians please tell me you’re joking.

  • @aloza09
    @aloza09 2 года назад +16

    As a mom of a child with a disability, owlet has been invaluable to our sleep and making sure she is safe during sleep time. It alerted us to a sleep apnea issue, so that we could request a sleep study and now we do have a hospital grade pulse oximeter and I can verify owlet and the pulse oximeter from the insurance company is very close. So much that we much rather use the owlet. I hope this gets resolved soon

  • @Alex-iv4ee
    @Alex-iv4ee 2 года назад +39

    I think it is ridiculous that the FDA made them pull it. If it is harming children then that is different but this product is not. Parents using bad sleep habits are on the parents not a sock. When I was researching this product, prior to purchase, it was not difficult to find that it had not been reviewed by the FDA. So if you that is a requirement for you to buy the product then don't buy it. For them to do this after it has been on the market for so long is wrong.

    • @kelsd161
      @kelsd161 2 года назад +3

      A medical device is defined by the FDA in the same way a prescription medication is. It’s not the same as a vitamin or nutritional substance which is not approved by the FDA, because the sale of those things can be endorsed by the FDA but are not directly regulated by the FDA. A prescription medication (like medical devices) must be approved by the FDA before sale OR apply for an exemption in the case of emergency (like vaccines for example). The marketing of the Owlet used language which put this product under the definition of a medical device (it said it was used the prevent SIDS), therefore needing FDA approval before sale. I see your point but I think the issue here lies in the Owlet team not going through the proper legal outlets before sale and not in the FDA doing their job.

    • @Alex-iv4ee
      @Alex-iv4ee 2 года назад +2

      @@kelsd161 how is this device any different than the blood oxygen sensor in the Apple Watch? Both read blood oxygen levels. Both listed as not a medical device. Both not approved by the FDA. Only one gets this letter from the FDA and pulled from the market. Regardless of what the FDA wants to claim or define they are letting other companies sell products that have an O2 sensor that they didn’t review.

    • @Alex-iv4ee
      @Alex-iv4ee 2 года назад +2

      @@kelsd161 If the owlet team made a claim of it being a medical device or marketed it as a cure for SIDS than that is a problem that lies with their marketing team. I never saw that myself and researched it heavily 6-7 months ago. Even if they had made those claims, pulling the product isn’t the answer. The company could put out corrections and I think the FDA can fine a company. Not totally sure on the fine but there should be another outcome short of pulling a device that is not causing anyone harm.

    • @sha8photo
      @sha8photo 2 года назад +2

      Yeah this seems like huge overreach. It’s not the company’s fault if parents practise bad sleep?

    • @NataliaoRI
      @NataliaoRI 2 года назад

      ​@@kelsd161

  • @annarocha3254
    @annarocha3254 2 года назад +28

    I very much dislike the FDA in this regard. So many products that could help people are not on shelves because of FDA bureaucracy.

  • @futbolfreestyle036
    @futbolfreestyle036 2 года назад +14

    My baby was born premature 10 weeks early. She spent 4 months in the NICU, had surgery for double aortic arch, and was on ventilator and oxygen due to her trachea until a week before leaving the NICU.
    One of the Drs. at CHOP wrote a negative article about the sock. Never the less when they wanted to remove her hospital oxymeter we told them we would be bringing the Owlet into the hospital. He happened to be her attending physician her last two weeks there. He respected our decision and allowed us to see if owlet readings would correlate with the hospital grade equipment.
    We had multiples discussions as to the use of the device being auxiliary to the standard checking her color, making sure she sleeps face up, crib be empty of items, no co-sleeping, etc.
    By the end of our stay Owlet sock 3 had matched exactly to the medical oxymeter the whole time. After our discussions our Dr, seemed to understand our use of it and didn’t discourage us.
    Since being home since end of June of this year. She has slept with her sock every night. It has never provided a false alarm to us. We even know when she’s about to wake up and when she is deep asleep based on heart rate. As well as know when she learned to flip over when she was too face planted in her crib.
    This device is the best investment my wife and I ever made, I would pay 3-4 times the price if that is what it took to get it back with fda aproval. But, let’s be real. It’s not a hype product or gimmick, it works. No one is arguing that right?! The fda just wants their cut.
    The only negative impressions you get from medical doctors is parents that would only rely on the device and not practice safe sleeping habits. For many parents of healthy babies that feel like it would just cause anxiety or false alarms, would you not take that and have an extra layer of protection in exchange?
    How many people like my self would vouch for this product if it didn’t work or likes some cases actually save their child’s life!?
    Not everything Owlet is rainbows and sunshine, the camera has been a fail, it took a lot to work it out it’s problems just to return it and the second unit we got has been flawless.
    In the end. Owlet will be back eventually when they get their fda clearance, in the meanwhile they’ll sell the sock 3 as “sleep sock” without oxymeter readings and hopefully reactivate that part of it when Uncle Sam gets his cut.

    • @laurenwalters51
      @laurenwalters51 2 года назад +1

      They just started a web based app for the smart sock 3. I have one for my fourth child (1 month old) and wish I would of had one for my others too. It’s a huge help to my post partum anxiety and I do trust it

    • @TenshiR
      @TenshiR 2 года назад +1

      My wife and I also got an owlet 3 years ago for our premature baby. It also gave us a piece of mind as well. It actually alerted us a couple times to certain situations that lead us to bring him to the ER. One of the times I brought it with me to compare it with the equipment at the hospital. Sure enough the readings were similar. The doctor that was attending to us was even impressed.

    • @ballglamis
      @ballglamis 2 года назад

      @@laurenwalters51 how do you like it even though it doesn’t have the pulse ox reading? I think I’m going to return mine because the product isn’t the same.

    • @lynnhua4735
      @lynnhua4735 2 года назад

      @RiGo how did you use the owlet in the hospital without wifi? Did you connect to their wifi?

  • @KarenBanaszak
    @KarenBanaszak 2 года назад +12

    I appreciate the depth you went into with this video in covering this tricky legal topic. The part that doesn't sit right with me is how you change your mind in retrospect about actions you took as a parent of a newborn. It's easy to tell that former self "You should have done X Y Z with your baby" when you are no longer in the difficult situation of having to care for a newborn. Don't lose sight of your empathy. Anyway, I hope that the FDA clears the Owlet quickly, but more importantly I hope that products that can save lives are available to the parents and babies who would benefit from them.

  • @KarenM2012
    @KarenM2012 2 года назад +13

    after losing our daughter last year suddenly and unexpectedly (not to sids), my husband and I got the owlet to increase peace of mind overnight so we could actually sleep. So glad I downloaded the app early. It has brought us peace of mind and actual sleep overnight this past week and I pray everything gets worked out with the fda. Also, just for the record, we are very strict with safe sleep

    • @malorie8557
      @malorie8557 2 года назад

      I'm sorry for your loss.

  • @sha8photo
    @sha8photo 2 года назад +7

    As someone who isn’t American, I really don’t care if the FDA wants me using it or not. I just want to be able to use it.

  • @Pinupvixen3
    @Pinupvixen3 2 года назад +10

    I’ve used the Smart sock for both of my babies. My newest little one was born in October and we bought the newest Smart sock for her. We started getting red alerts when she was about two weeks old and brought this up to our pediatrician. Turns out our daughter has SVT (a heart condition which causes her heart rate to spike). This condition is such that it’s symptoms are mostly undetectable and in a baby who can’t tell you that they are having palpitations, shortness of breath, feeling dizzy or having chest pains it would’ve been impossible for us to know. It may have not been diagnosed until childhood or even early adulthood if not for the owlet. I’m so torn about this device being pulled and I really hope they don’t pull the support. Seems like they’ve pivoted to this new “Dream sock” which doesn’t seem to offer what the former Smart sock did.

    • @boerir
      @boerir 2 года назад +3

      Working in the medical device field, the abilities of the dream sock, in other words, what it actually monitors, are EXACTLY the same as the Sleep Sock. The only difference is level of detail provided in the app. The breathing and O2 is still being monitored (the Owlet website actually says this on their website) but you cant see those exact numbers anymore. Instead that information is fed into the dream app. The alarms that go off are for the same information trigger, it's just us on the user interface side that dont get those details. By removing those details, it allows the dream sock to be once again in the "wellness" catagory instead of having to get FDA approval as a "diagnostic" device.

  • @hannahsnyder2997
    @hannahsnyder2997 2 года назад +3

    Thank you for making videos like this! I have been watching your videos for years, still doing my research as we are still family planning. I love how you bring in the tech side to growing families. Please keep making content for the (hopefully soon to be) new moms that are nerds about tech. :D

  • @alixdantzler2531
    @alixdantzler2531 2 года назад +7

    I have had my Owlet in the box for months now, baby due in Jan. I was bummed to hear this but I was able to download the app. So I am hoping to still be able to use it as I feel comfortable with it in addition to our safe sleep practices we will use.

    • @kierraherrod9819
      @kierraherrod9819 2 года назад

      did yours still work? my baby is due in a few weeks and i’m having issues connecting mine as it’s been in its box for months also.

  • @fusedtony
    @fusedtony 2 года назад +14

    This monitor save my baby. It alert me when my daughter got apnea spell while we where sleeping. I ran to her and she was already turning color and had to pick her up and wake her up. If it wasn't for the owlet I don't even know what would've happened. I'm so glad we purchased the owlet 3.

    • @JCTJ07
      @JCTJ07 2 года назад +2

      Hi I have the owlet 3 as well. I read your comment about getting an alert. How did you know your baby was having a apnea spell? Our sock went off with low oxygen for the first time. my baby is almost 3 weeks. I woke her up so fast but now I am paranoid..

  • @Jonathan-nk4tc
    @Jonathan-nk4tc 2 года назад +5

    The owlet was my favorite thing we had for my first born. It was a very expensive purchase but I loved the analytics and the extra peace of mind while sleeping. I do agree that we got in bad sleeping habits though. The part I was frustrated about was I wanted to use it for my 2nd child. They were 22 months apart and we were 10 months past the 1 year manufacturer warranty when the owlet would not charge. After troubleshooting and speaking to customer service they had discontinued our model and gave me the option to spend even more than we did on our first one for the newer model. I did not repurchase because for such an expensive product it should have a longer life or better replacement/warranty procedures in place. It was a very sad day to not use it but we practiced MUCH BETTER safe sleep habits for our 2nd child.

  • @TenshiR
    @TenshiR 2 года назад +2

    I think I mentioned in your original video that we purchased the original owlet 3 years ago based on your video. We loved it so much that we bought it as gifts for friends who were expecting.
    It helped give us peace of mind when we brought our first child, who was a premature home. It also alerted us on a few occasions that led us to bring him to the ER. During one of the trips to the ER, I was curious and brought the device with us to compare it with the equipment at the London hospital. The two readings were identical. It even impressed the doctor who was attending to us.
    Our first is now 3 and is good and healthy, but we just had another premature baby born last week. We still plan on using the owlet. We don't see it as a cure all but as an extra precaution. I've also noticed it's still for sale in the UK.

    • @lynnhua4735
      @lynnhua4735 2 года назад

      @RiGo it’s still for sale in other countries besides the U.S. we just got ours through a European website.

  • @procrastinationproductions5012
    @procrastinationproductions5012 2 года назад +5

    As a parent of a baby that had a long NICU stay and has witnessed him have apnic spells in his sleep. We bought it simply because we got so dependent on the monitors in the hospital to know if he was good and although the hospital didn't allow him to go home until he grew out of his spells, it was just a piece of mind one he came home when we put him down to sleep

  • @stevenaguilar8331
    @stevenaguilar8331 2 года назад +2

    This video came at the perfect time. I couldn’t figure out why the app just randomly stopped working. We used the owlet with our daughter and never had any issues. Our son was born on Saturday and our plan was to put the sock on him when we returned from the hospital and to our surprise, the app wouldn’t work and I couldn’t figure out why! I will admit, it did give me a peace of mind with our daughter, but now I just have an excuse to buy the Nanit monitor and put the sock aside until Owlet figures out their FDA issues.

    • @lilgv4584
      @lilgv4584 2 года назад

      I'm on the US and the app still works on Android not sure if this is only an issue for iOS. I hope it is bc I own the nanit and the owlet and I still prefer by far the owlet.

  • @AuthenTech
    @AuthenTech 2 года назад +7

    Have you seen the show Dopesick? Lol it shines a beautiful light on the FDA

    • @dadverb
      @dadverb  2 года назад +3

      I definitely find it interesting that all of this happens shortly after Owlet becomes a publicly traded company.

  • @sandraviktoria4623
    @sandraviktoria4623 2 года назад +3

    This saved our then 12 day old daughters life.

  • @BabyKristina
    @BabyKristina 2 года назад +1

    As a mum of a child who spent her first 4 months in NICU this is a lifesaver! We can buy them freely in Australia, hopefully they will stay on the market.

  • @midwestreefer2902
    @midwestreefer2902 2 года назад +1

    Is there a separate app for the camera? I have the owlet sock and cam which we bought in 2019, my daughter is 2 and we've still been using the camera, I plan on using our sock for our baby due in June, I am not going to stop using it, helped diagnose breathing issues for our daughter who was born with heart defects. If we didnt find out she might've died. I had no regrets of my purchase but how do they expect to use the cam if they get rid of the app

  • @notsoamyable
    @notsoamyable 2 года назад +1

    We’ve been using the owlet since my 9 month premie came home. I’ll admit at first I’d stare at it all night long and take the numbers too seriously. But now it’s just a peace of mind in the background for me. I hardly ever open the app, I just check the slow green pulse on the home base and that’s enough for me to close my eyes and get some much needed sleep.

  • @samanthakelley6390
    @samanthakelley6390 2 года назад +1

    Our little one ended up coming 6 weeks early. He spent the first 3 weeks of his life NICU. He had 2 apnea spells when he was there & I was certain that the Owlet was going to be a purchase for when our little one came home. We had gotten so used to watching his levels on the hospital monitors & loved the reassurance that everything was ok.
    We spoke to our medical team about it & to our surprise we were met across the board with a resounding "No - Do not purchase or use one".
    They said 1. If he needed something like that, the hospital would provide one & 2. If he's discharged it's because he's safe to come home and we had to learn to trust him.
    Safe sleep practices were the thing that was hammered in day after day & because I'm an anxious personality they gave me multiple SIDS studies to sift through.
    A well respected study (from 2015 in CA) cited that 99% of all SIDS death were due to something preventable & attributed it unsafe sleep habits.
    Knowing that the overwhelming majority of SIDS is preventable brought some peace & we chose to fully trust our medical team & our son that he was ready to come home.
    He turned 8 months on Tuesday & although there have been some helicopter moments, we are still happy thst we went the route we did.

    • @paulacruz6239
      @paulacruz6239 2 года назад +1

      I know this response is from long ago. But I had to say this. The baby had 2 apnea episodes on the hospital were all the precautions are made to make sure SIDS was not a situation. They detect it base on monitors for sure, and yes it was a premature, so lounges are not total developed, but saying something "you need to learn to trust him" is not a thing, specially with a premature baby, conditions can be present without one knowing, is not about trust, its about making sure you know everything is ok. Just yesterday I found out of a baby that had died with just 2 months and the parents never knew how it append, no one could pin point exactly how or why she died.. So I totally don't agree that you should just trust, even if accidents are preventable, already pre existing conditions are not.

    • @kris580
      @kris580 Год назад

      @@paulacruz6239 Agree. I recently read that deaths due to medical error are very high. I think devices like this are *supplementary* and secondary to consistent safe sleep practices. I just can’t see how this could cause harm *if* parents are already practicing safe sleep habits for their babies. I wish there was more info available to us. Id like to know how many babies lives were saved because of this device, I’d like to know how many babies were diagnosed with a health condition because the parents were alerted by this device, and I’d like to know how many babies died while using this device and the details surrounding the deaths: were they practicing safe sleep habits, etc.

    • @paulacruz6239
      @paulacruz6239 Год назад

      @@kris580 I believe the main problem is the fact that they assume that if you are using this you will neglect safe sleep practices, and that's not the case for the vast majority of people. How can someone, that is spending this kind of money to reassure that their baby will be ok, will then just neglect all the safety recommendations? Why can they just highly advise people to not Only relly on this, but also Always insure safe sleep practices no matter what? That baby that I mention, that was very traumatic to the mother, and she was now pregnant again and could not even sleep or eat properly just because of the stress of something happening to this next baby, she did not know about this device, and was extremely relieved to know about it. You are totally right, that information would be essential and should be public knowledge, unfortunately, don't see anything off sortes happening soon.

  • @MichaelSmith-dr8tw
    @MichaelSmith-dr8tw 2 года назад

    We still use ours, even though I got a new phone and now we have to rely on only moms phone. The fact is that we practice every aspect of safe sleep that we can and having just that little extra is only icing on the cake.

  • @nicolecook1245
    @nicolecook1245 2 года назад

    Can you share which parent groups you follow? Any suggestions for 1st time mom?

  • @arriellegiles8077
    @arriellegiles8077 2 года назад +1

    I'd love to see you do a video on the weighted sleepers that are now being marketed everywhere for infants.

  • @tjnoor5901
    @tjnoor5901 2 года назад +5

    Owlet seems to have released a new version of the sock. Not sure what’s missing or what’s new - would love your input on it! It’s called “Owlet Dream Duo” now.

    • @ballglamis
      @ballglamis 2 года назад

      It’s basically a new product, does have pulse ox reader.

  • @jemmarichardson6614
    @jemmarichardson6614 2 года назад

    Hi do you know of any. Breathing mats ect... That are fda approved for new borns ?

  • @jessicapiekarski6929
    @jessicapiekarski6929 2 года назад +6

    I think when the parent is already practicing all safe sleep practices and still wants to be able to monitor the baby's heartbeat and oxygen levels for peace of mind then it is a good idea. I love the owlet sock for my 3 month old. It has only had three red alerts so far, 2 for low oxygen and once for low heart rate. Who is to say whether he would have been okay if not for me being alerted there was a problem. Obviously this type of product isn't meant to be a crutch for poor safety habits but in addition to following recommended safety sleep guidelines.

    • @kaylak3405
      @kaylak3405 2 года назад

      Hey! Being that the app is no longer available, may I ask, does the base alert you in the same way that the app would? It makes a noise?

    • @jessicapiekarski6929
      @jessicapiekarski6929 2 года назад

      @@kaylak3405 ours does but we also still have access to the app and all the original features because our app was set up prior to it being changed. The base does make the correct sound but I don't have experience using the sock exclusively without the app. In my experience it does make the corresponding alert from the base as what the app does but I don't know if you purchased a sock after they took away the heart and oxygen functions.

    • @kaylak3405
      @kaylak3405 2 года назад

      @@jessicapiekarski6929 I purchased it used, and it has all of those functions. I’m so upset about the FDA making them take down to app. It’s my first baby and I really only wanted to sock for a little extra peace of mind. Bummer. I’ll try it without the app and see how it works, thanks for your response!

    • @lynnhua4735
      @lynnhua4735 2 года назад

      @@kaylak3405 does it still work without the app? We just got one and haven’t set it up yet.

    • @kaylak3405
      @kaylak3405 2 года назад +1

      @@lynnhua4735 hey! So I downloaded the app and converted the sock to the “Dream Sock” and yes, the app works now!

  • @LVNITUPM8
    @LVNITUPM8 2 года назад +2

    So basically someone at the fda hasn't got their kick back and is throwing a hissy fit

  • @bradleydnbwnba1
    @bradleydnbwnba1 2 года назад

    So does anyone know what app you can download to get the smart sock 2 to work? I have two newborns at home and would really like to get these to work. Thanks

  • @ChrisEsparza
    @ChrisEsparza 2 года назад +4

    I knew there was a reason my wife and I skipped out on this! Glad to see we didn't spend the money unnecessarily. Thanks for the in depth information!!

    • @dadverb
      @dadverb  2 года назад

      You're very welcome. May I ask which monitor you went with?

    • @ChrisEsparza
      @ChrisEsparza 2 года назад

      @@dadverb We have a Wyze security camera mounted above her crib and keep an eye on her from our phones.

    • @CatherineCarol
      @CatherineCarol 2 года назад

      I am still using the Nanit but I didn’t use the breathing band or swaddles after one month because of false alarms generated. The sleep analysis is what I enjoy and sleep coaching tips. This enabled me to sleep train my baby and she sleeps through the night well now. It also enabled me to train my child to self soothe herself to sleep.

  • @waynechen8254
    @waynechen8254 2 года назад

    It's ridiculously expensive to run the studies for a medical device certification through the FDA, not to mention the application itself. Sometimes, the FDA will also arbitrarily require additional testing/studies/documentation of some devices versus others, particularly so if you're the first company actually trying to get a device approved for non-doctors office use only.

  • @broghan17
    @broghan17 2 года назад

    You can use a web link for the owlet smart sock 3 still. No app, but it works the same minus the notifications.

  • @carlagreco494
    @carlagreco494 2 года назад +1

    Owlet is bringing back a new sock soon and I believe it’s the same one but different wording. It states that it’s just to check if the baby is sleeping comfortably

  • @purieh
    @purieh 2 года назад +1

    They're releasing a dream sock on January. I wonder if it's the same and they just renamed it?

  • @neosworld4659
    @neosworld4659 2 года назад +1

    Omg! I’m still TTC, I’m going to try to get one off the FB marketplace now just in case I can’t get one when I need it.

  • @wildcat62282
    @wildcat62282 2 года назад

    Does this mean used models won’t work because the app will be shut down? Wondering if this decision will drive up or down the price for the resell market

  • @robertsari
    @robertsari 10 месяцев назад

    Well in Germany its available on amazon and the app is available

  • @rapIlike1
    @rapIlike1 2 года назад

    I ♥️ the owlet.... It just helps out so much! Let's you know how your baby is sleeping.... Also my baby loved to boppy lounger... But I can see how it can be unsafe if you as the parents are tried and little baby is not positioned in it correctly. Just get the safe see through mesh baby bassinet and put it right up next to your bed.

  • @daisyangel891
    @daisyangel891 2 года назад

    So I just bought one cyber Monday, however I’ve been having trouble registering it… can this be why? We also got the nanit, but because she’s in the mamaroo bassinet I wanted the sock for the first 6 months

  • @carlyvalentin
    @carlyvalentin 2 года назад

    A rep for owlet told me theyre going to have an app from their website available by January

  • @lauramoreland3153
    @lauramoreland3153 2 года назад +1

    Thank you for this video. I also almost bought into the Owlet hype during the beginning of my pregnancy; but that was before I learned about safe sleep. I will never break the ABC's of safe sleep, because the rule is simple, it works and it gives me peace of mind.
    I love your videos! They've helped my husband and I navigate through parenthood like pros!

  • @AMJenne
    @AMJenne 2 года назад +4

    This is not what an 8-month pregnant women needs to hear this close to giving birth. I never intended on using this sock in place of safe sleep practices. This is asinine, I now have a $300 piece of garbage collecting dust. So devastated that I can’t use this. Looking at spending another $150 at least to get a Samsung device, hoping I can use it then. 🙄

  • @CrazyCanucker14
    @CrazyCanucker14 2 года назад

    I'm guessing this is only affecting the States? Seems I can still download the app and purchase the Owlet in Canada

    • @dadverb
      @dadverb  2 года назад

      I'm not 100% but I believe this regulation is only pertinent to the US.

  • @leandreigdtan5133
    @leandreigdtan5133 2 года назад

    Is there another brand more reliable than Owlet? Looking for another one for my newborn. Thank you!

    • @dadverb
      @dadverb  2 года назад

      I can't definitively say that there is one more accurate. Because Owlet was an actual pulse oximeter, it technically offered the best accuracy compared to monitors that do image processing. While the perform nicely, I don't know that they'd be considered 'more' accurate.

    • @Billy_Silva
      @Billy_Silva 2 года назад

      Neebo

  • @KevinJacksonDrummer
    @KevinJacksonDrummer 2 года назад +2

    This sucks! I haven’t gotten as good of sleep lately without this thing running all night while my 6 month old is sleeping…. Still running the baby monitor but am CONSTANTLY waking up and watching her to make sure she’s ok. Sometimes feeling the need to go touch her and make sure she’s breathing. Don’t think I sleep more than an hour at a time. 😩😩😩
    This thing was awesome and miss it.

    • @makennaduff5804
      @makennaduff5804 2 года назад

      I don’t understand, why did you stop using it?

    • @KevinJacksonDrummer
      @KevinJacksonDrummer 2 года назад

      @@makennaduff5804 app went down (I assume because of what’s discussed in this video) and can’t get it fired back up.

  • @nicolecook1245
    @nicolecook1245 2 года назад

    I also LOVE my owlet! I do not use it or rely on it. It’s more of a “nice to have” and to supplement.

  • @matthewtuel2747
    @matthewtuel2747 2 года назад

    This is disappointing and we will return the sock as we haven’t used it yet. It seems someone didn’t grease the wheels enough.

  • @tessak5869
    @tessak5869 2 года назад

    Can the smart sock be used without the app? I just bought the sock before it was pulled off of Amazon but did not get to download the app before that was pulled. Does anyone know if it can still be used without the app?

    • @lilgv4584
      @lilgv4584 2 года назад

      You do need the app to do the setup and also to see the stats.

    • @makennaduff5804
      @makennaduff5804 2 года назад

      No- you do not need the app. The sock connects via Bluetooth to the base. It will still alert if levels go outside the parameters, you just won’t be able to actually SEE the numbers on your phone. With my now 4yo when he was an infant, we didn’t have Wi-Fi, so I only relied on the alerts from the base. Worked great. Now that we have Wi-Fi, it’s even better- but not necessary.

    • @lynnhua4735
      @lynnhua4735 2 года назад

      @@makennaduff5804 since you don’t need WiFi. You can use the sock anywhere even outside your house as long as the sock is connected to the base through Bluetooth?

  • @bkaye7253
    @bkaye7253 2 года назад

    Can you do a new video on the dream sock 🙏🏼

  • @jamo_8972
    @jamo_8972 2 года назад

    Does this also apply to Europeans, or is it only in the US?

  • @BisyBackson365
    @BisyBackson365 2 года назад

    Is it really worth while to have these kinds of monitors for Baby? Expecting new dad, and being how much I love science tech, I was surprised to see how much monitoring I CAN do. But should I? Is it worth it? Is it a really helpful tool?

    • @rocketb00t
      @rocketb00t 2 года назад +3

      As a father to a 4mo, I would never use something like this. You can stress yourself so much monitoring your baby while they sleep, so we've opted for a minimalist approach. We have a video monitor that we only turn on if we hear him fussing (nursery is across the hall, so we can hear him cry out). We found that constant monitoring caused us to obsess over every movement, which was negatively affecting our sleep. With a heartrate monitor, I feel like it would be 10 times worse.
      But do whatever works best for you! Congrats and good luck!

    • @rocketb00t
      @rocketb00t 2 года назад +2

      @Brian Faber Fair enough! Whatever helps you and your family sleep better! We just went through the dreaded 4 month sleep regression so I can attest to the value of solid sleep for everyone.

    • @rocketb00t
      @rocketb00t 2 года назад +1

      @@CaliMel184 Those who have been lucky enough to have not suffered it may say it's overblown, but those of us that have been through it can tell you it's very real and you should at least be prepared for it! My wife and I weren't ready because we had heard that same thing, and we wishfully thought it might not happen to our baby. But after a week of waking every 20 minutes we were cursing every person who suggested it might not happen to us!
      I would almost plead with amy first time parent to be aware and prepared for the possibility. Our baby started rolling over the same week the regression started, so we were stuck trying to wean him out of the swaddle at the same time!
      If anyone has the luxury, meaning their baby is giving them a few hours of decent rest every night, try to move away from any sleep crutches as early as possible.

    • @lilgv4584
      @lilgv4584 2 года назад +1

      It depends on the person but there's also something called postpartum anxiety which is very real and I happen to have, so this kind of tech help ease some of my fears.

  • @mackenzielynn7653
    @mackenzielynn7653 2 года назад

    Does anyone know if they’re issuing refunds? Their site says only 30 days

    • @dadverb
      @dadverb  2 года назад

      I'm unsure at this time. Since this wasn't a major recall like we saw with CPSC and Boppy, I don't know if there's a mass refund structure in place or if there will be. The best that consumers can do is message their support team and request a refund even if beyond the 30-day window since it's a unique circumstance. If bought through a different seller, you'll likely need to go through that store.

  • @TXAslingr
    @TXAslingr 2 года назад

    I like the sock. Its useful for a variety of reasons.

  • @raha1277
    @raha1277 2 года назад

    It’s not that it wasn’t approved as in it was harmful it’s that it the FDA’s process is crazy long.

  • @AbdullaHernandez
    @AbdullaHernandez 2 года назад +1

    Subhanallah, the FDA stopped parents getting a life saving product because they wanted their cut. It isn't just letters they're waiting for.

  • @bambils123
    @bambils123 2 года назад

    My baby almost died in a rock and play! I just found out they are recalling them for that exact reason.

  • @father6371
    @father6371 2 года назад

    Unless your doctor tells you, you don't this anxiety building thing

  • @brittanybowen7710
    @brittanybowen7710 2 года назад +2

    The best advice I got regarding the owlet and similar devices from my pediatrician: these devices are not medically reliable and have a tendency to shoot your anxiety through the roof. There is no preventing SIDS.

  • @ballglamis
    @ballglamis 2 года назад

    I just want to update this comment section so people are aware. The new owlet doesn’t have a pulse ox reading with the new Owlet Dream app. I’m returning mine. I hope the FDA approves soon as my baby will be born this week. I hope they understand they’re removing the ability to save babies lives by coming down hard on Owlet, not cool. I also hope that they can reimburse Owlet for lost sales, reimburse parents for anything that happens to their child because they decided to remove the app off the market, so frustrating.
    Maybe Owlet should just change their description so they can avoid this whole headache with FDA who can’t prioritize what is important in this world to improve babies lives. They’ve approved e-sigs, vaccines, prob more things, but not an actual proven life saving product. 🤦🏽‍♂️

    • @paulacruz6239
      @paulacruz6239 2 года назад

      Hi, for what I read on the site it still has the ox reading, they actually say that the Owlet uses ppg technology and "Owlet’s Dream Sock tracks and gives insight to certain factors, through tracking critical sleep quality indicators like: heart rate, oxygen level, room temperature, noise level, wakings, and movement.
      Owlet’s proprietary algorithm gets to know your baby by tracking your baby’s sleep quality indicators to learn your baby’s sleep baseline. If your baby’s sleep indicators differ from the expected baseline, you will receive a “Sleep Assist” prompt on your Base Station and in the Dream App letting you know baby may be uncomfortable or need help getting back to sleep."
      This are the same functions as before, but they now described as something to help you understand you baby sleep and not as a device to check your baby health.

  • @Burritosarebetterthantacos
    @Burritosarebetterthantacos 2 года назад

    My issue with owlet is the wonky tech and the foot alarm is way too sensitive. I honestly think the owlets woke us up more than the baby.

  • @ADs548
    @ADs548 2 года назад

    They brought it back and is now called the owlet dream sock 😀

    • @ballglamis
      @ballglamis 2 года назад

      They didn’t bring it back, it’s basically a new product that doesn’t read baby pulse ox

  • @boerir
    @boerir 2 года назад

    Hey Andrew. Having worked in the medical device field and with the FDA I wanted to provide a bit of insight and a correction. The FDA is NOT saying that the device is unsafe or that parents shouldn't use it, or that owlet cut corners in its product quality, rather they have issue with the device marketing itself as a diagnostic device when it hasn't passed the ASTM and FDA testing requirements. It's purely a paperwork exercise not a device issue.
    If the FDA actually thought the device was even remote unsafe or might cause more problems, their letter would have been a recall, not a request to stop selling and marketing. It may seem a small difference, but in actuality it is a large one in both the end user result and the legalities of it.

  • @atherton3221
    @atherton3221 2 года назад

    Any way you can comment on new owlet dream sock?

  • @CruisinwithCoCo
    @CruisinwithCoCo 2 года назад

    Probably because certain organizations aren't making money off the Owlet.. smh

  • @CanadaSocial
    @CanadaSocial 2 года назад

    It’s best not to buy it as the website does not easily take you to to the pages for the FDA response and the app updates. The page flashes for a moment and then redirects to the main shopping page. That shows that the company is not being transparent about the issue and still trying to sell items.

  • @DrTroop
    @DrTroop 2 года назад

    the FDA will work to save lives after it is dissolved. as of now it's focus is money and funding

  • @Hardy_Productions
    @Hardy_Productions 8 месяцев назад

    Money! It all boils down to money. Gotta grease those skids. "Federal" agency lol... When has the federal gov actually protected us? Anyone who thinks so is crazy. Compare food additives of our country vs say the UK, or any European nation. Is our FDA really smarter than all them?....

  • @trentasenzalode
    @trentasenzalode 9 месяцев назад

    thanks for the video but i dont know if all the comments are real here...

  • @PratheLa1
    @PratheLa1 2 года назад +1

    Who cares what the FDA says?

  • @OzSome1
    @OzSome1 Год назад

    They didn't grease the right palms period! Fda is a joke!

  • @ea1420
    @ea1420 2 года назад

    I’m thrilled Owlet has been taken off the market. Because they did advertise their device and implied it was on par with hospital grade monitors. And, they are not. They don’t have any scientific data (done through peer reviewed studies) demonstrating that. While many people watching your videos may use this type of device responsibility in conjunction with safe sleep practices many parents do not. I hope things like the dockatot also get removed from the market. I say this as a parent of a kid who was in the NICU for weeks and who was told repeatedly from NICU nurses not to use those kind of monitors. An unpopular opinion here I think.

    • @ballglamis
      @ballglamis 2 года назад

      At the end of the day though the product works and parents should use the product appropriately. It’s a proven product, just read the great reviews and life saving stories.

  • @iangavin631
    @iangavin631 2 года назад +3

    This sock is trash glad the FDA stepped in

    • @ashleynoble2880
      @ashleynoble2880 2 года назад

      What do you dislike about it? I didn't want something this complicated.

    • @whosaidthat9265
      @whosaidthat9265 2 года назад +2

      @@ashleynoble2880 it’s not trash. I have had one for almost 2 years. I used the sock for my first child born last year and used it for my second child born this year. I liked it and found it to be a tool that added peace of mind. I never had a problem with mine.

    • @lilgv4584
      @lilgv4584 2 года назад

      If you don't like it don't use it. Many find it useful, do whatever is best for you. The goverment don't need to decide what can or can't use.