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2024/05/25 Can You Get And Use Soft HBOT Chambers of More Than 1.3ATA for Hyperbaric Treatments in the US?
π 2024-05-25 01:01 by Merlin in Hbot
I'll start this by staying, I'm not a doctor, I'm not a lawyer, I'm not a sales person, and I'm not a medical device medical engineer with FDA approval/regulations specialty, although I did use to live with one for over 10 years, so I have some understanding of that FDA process while not being a specialist on it either (but neither are most who talk about it). Before I continue, I'll point out that multiple people who post about HBOT and call themselves doctors are not medical doctors with medical degrees, and therefore their medical background or opinion should be on the same level as mine. You should trust what I say no more than what they say, but hopefully I'm giving enough reasoned information below that matches what's currently happening in the US market, that you can consider my points as hopefully valid.

Now that this is out of the way, I'll summarize what I've read and seen, partially to help others, as well as encourage someone who actually knows this stuff inside and out, to tell me if I'm wrong, why, and show me supporting evidence like clear FDA regulations and how they apply to what I'm going to explain below. I will however say right now that I will only consider "you're wrong" opinions with clear supporting evidence in a well written reply with references and ignore you if you say "I know this stuff, but I don't have time to write the details as to why I'm right and you're wrong".


  • way too many people post in the US that soft chambers can only be 1.3 ATA at most in the US
  • incidentally all of them I've talked to myself, happen to sell/resell soft chambers, and from what I saw all of them sell/resell soft chambers made by US manufacturers. Potential conflict of interest obviously.
  • my understanding is that US manufacturers of soft chambers must make such chambers to meet one FDA approved use, and there is only a single FDA approved use of soft chambers, namely to transport a patient with decompression sickness to a hard chamber capable of higher pressures (treating DCS can require pressures of 3 ATA or more, which soft chambers are not capable of). If you have heard of double blind placebo controlled studies, this is where those come in. They make sure not only the treatment is not otherwise harmful, does help for the intended use, and helps more than spontaneous healing due to luck or people healing themselves by the power of their mind (if you think this is a joke, it is not, look up "placebo effect"). The premise for those studies is sound, but they are slow and expensive.
  • Whoever paid for that FDA study to get soft chambers approved for it likely had to pay millions of dollars and spend over a year to get this approved, that's how the FDA works. If you want to add a new FDA approved use, or change the chamber pressure to 1.5 ATA, you need to do a new study which can cost again about a year and millions of dollars. Few companies have that time and money.
  • there are 14 FDA approved uses of HBOT in hard chambers, and covered by insurance, and they are listed in this page. Odds are none of those are what you are trying to do, or if they were you'd likely go to an approved hard chamber facility and get those treatments and reimbursed by insurance:
  • Most uses of hbot by people looking at buying their own chambers for home use, are off label. Off label means using an FDA approved drug or equipment for a medical use other than one that was part of a tested and approved use tested by a study. It is actually a huge loophole in the system, it allows using just about any drug or equipment for any ultimately other use that wasn't properly tested as part of a rigorous study as described above. For instance if you are using trazodone, an anti depressant, for sleep, or gapabentin (an anti nerve pain drug) again for sleep, or even seroquel (an anti bipolar drug) for sleep, those are all off label uses and none of those 3 drugs were rigorously tested to work as sleep drugs, although many doctors know by now they work well for that use too and prescribe them to some patients for deeper/longer sleep.
  • Back to HBOT, my point is that by definition no off label use is FDA approved, but the good news is that the FDA does not prevent off label use.
  • In turn however, this means the 1.3 ATA limit on soft chambers for early DCS patient transport, does not apply since this is not what off label patients are using them for. However, US manufacturers apparently can only build soft chambers for an approved use, it's the only one, and it's limited to 1.3 ATA, hence the 1.3 ATA limit.
  • But this is where things get interesting: in the US (not true of Canada for instance), the FDA does not currently prevent a patient from buying a soft chamber made by a non US manufacturer, it does not prevent anyone from using any soft chamber at any given pressure including pressures above 1.3 ATA (you can make the point that there are some limited risks especially at 2.0 ATA and above for uninformed patients treating themselves without doctor supervision, so the FDA might want to regulate that use, but as of right now it hasn't been enough of a problem for them ot do so). The FDA does not prevent importing your own soft chamber capable of 1.5 ATA+ from a non US vendor, and from what I can tell it does not seem illegal for US resellers to sell non US made 1.5ATA+ chambers in the US to US buyers. That last part I'm not 100% certain about, but I know multiple US companies that sell them and if it's somehow not quite legal, that's ultimately their problem and risk not yours.
  • So there you go, this is why you can buy and use a 1.5 ATA+ soft chamber in the US, and why many resellers or US manufacturers seem to keep repeating it's not legal, when it totally seems to be for now. I'll now repeat that if somehow it were to be not super legal for US resellers to sell those chambers, as a buyer, do you really care as long as you can buy the chamber you want and need? Obviously my own answer is no :) In Canada, some users have found that they cannot get a soft chamber shipped to their home, but they can get one sent to the US and drive it across the border themselves. That's more of a pain obviously.

    I have seen other posts talking about non FDA standards related to construction, fire risk, maybe electrical norms (like anything sold in US is supposed to be UL certified). I am certain those chinese made chambers were not tested to meet each and every of those non medical, non FDA certifications, but apparently it's not against the law to sell, buy, or use them either, or if it is, no one seems to care or enforce that, so you can decide if you care yourself. I'll point out that a lot of stuff sold today on amazon or elsewhere also does not meet some of those other regulations either, or maybe they do or even exceed them, but they never paid to get certified to the US test/norm.

    The one thing you should hopefully care about is "is that soft chamber going to burst?", which would be a catastrophic failure that can cause injury and potentially really damage your ears if it happens at the wrong time at high pressure. This is where you have to decide how much you trust each product. Whether it's US made or not, does not make me feel that much better, and honestly a lot of "US made" stuff is really made in china anyway, just saying.
    The truth is that some Chinese manufacturers do care to make properly engineered and tested stuff, it's the same than when I was sourcing computer and electronic hardware from there, some was utter crap and would fail because it was cheap. Others were well made and tested to be durable by companies that did rigorous engineering and testing, using chinese testing norms that were equivalent or even superior to the US ones.
    The tricky part is to find which chinese companies you can trust, and which ones you should not. I used my experience in dealing with those vendors and knowing what questions to ask to get a good feel for my own purchase. Whether you want to trust my experience, research and feel, that's entirely up to you. I'm sharing the work I've done and the points to consider, so you can redo that work for yourself if you wish, but don't simply assume that if you're buying form a US manufacturer, everything will automatically be ok. There are enough clear examples of the opposite. I would say that it's true that if you get a 1.3 ATA only chamber, it's easier to meet those specs and limit the risks, but you're also settling for what I consider a lesser chamber compared to a 1.5 to 2.0 ATA capable chamber. It's your call at this point.

    There are US made 1.3 ATA chambers that have failed catastrophically (exploded). There have been fires in hard chambers with people dying because they couldn't get out, and the operator was not there to watch them and let them out. I have heard from a practitioner I worked with, of 1.45ATA soft chambers that failed slowly (leakage in seams or zippers that prevented reaching full pressure), but nothing catastrophic. I have seen 2 vendors of $8000 2.0 ATA chambers on meubon that sold chambers with no reviews and did not fill me with confidence (they are listed in my previous blog linked below). Those 2 Meubon listed chambers made me nervous enough that I would not use them and go in them even if I got them for free.

    So applying all of the above, this is what I did to get my own chamber:

  • I'm willing to believe 1.3ATA is sufficient treatment for some off label uses
  • I'm fairly convinced that for most of those treatments, they would work better and faster at 1.5 or 1.7 ATA
  • Some likely work better and faster at 2.0 ATA
  • I have read some opinions, that may be valid, that some specific treatment might work better at 1.5 ATA than 2.0 ATA. This is just a feeling, without a rigorous FDA double blind study, anyone who says anything either way (including me), is just guessing. I'll add that some of that advice came from someone who isn't a medical doctor with a medical degree, so it's jut an opinion based on personal research from public sources that should have the same weight as if you or I did that same research from similar sources.
  • I personally do not believe any off label treatment I care about needs or will work better/faster with more than 2.0 ATA
  • I found exactly one soft chamber that does 2.0 ATA and from a manufacturer I'm willing to trust after talking to them and their competitor for several weeks, and asking them tough questions to know whether they knew what they were talking about, and whether the had rigorous testing to back up their sales claim. Olive won over Hugo/Lannx, and if you are in the US you can get the 2.0 ATA one from the US distributor AHS /
  • If you don't think you need 2.0 ATA, or fully trust a soft chamber to do 2.0 ATA safely, don't you want to use a 2.5 ATA tested chamber at 1.5 ATA if that's your target pressure, instead of a 1.5 only ATA chamber that is reaching its design limits each time you use it?
  • This is the Olive 2.0 chamber I got for myself:

    For the rest, please read my previous blog on chambers and how I compared them. I also list 3 1.5 ATA only chambers you can pick from and that I would reasonably trust. The price is similar enough though that the only reason I would not buy the Olive 2.0 ATA chamber is if you don't like the car seat belt straps you need to use in addition to the zippers and that are needed for extra structural integrity. You can use them as a single user without help, but they add I would say 20 to 30 seconds of work getting in and out of the chamber without help.
    I will repeat this point because it's important: in engineering it's always better if you can to get a product that will exceed your requirements so that there is more of a design buffer between your use and the engineering limits. In my own use, I may end up using my 2.0 ATA Olive chamber at 1.7 ATA, haven't full decided yet.

    Here is the previous blog: Learning about HBOT/Hyperbaric Oxygen Therapy I was referring to. I would also repeat from that previous blog that aside from the actual chamber safety, you should very much care that the concentrator and compressor can deliver at least 7lpm of 95% O2 at your target pressure. I will say right now that too many products (even some 1.3 ATA chambers when OMG, it's not hard to deliver at that low pressure) fail to deliver the right amount of airflow, or if they give you the airflow, they fails to deliver enough O2 percentage at that airflow level.

    So there you go, hope this all helps, good luck on your selection and purchase.

    After writing this, I did find two resources people cite as problematic:

  • NFPA-99: This overview of NFPA-99 states the code "is not mandatory" thus it is not a law, even for healthcare facilities:
  • NFPA-55 - You can't have bulk oxygen (generally classified as more than 13,000 cubic feet) in residential areas or housed indoors: this is not relevant to chambers that use O2 concentrators since they make that O2 on the fly and none is stored in your house

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