What HBOT Is Actually FDA-Cleared to Treat: The 13 Conditions

The short answer: The FDA has cleared hyperbaric chambers for 13 conditions (list last published July 2021). The UHMS separately approves 15 indications. Medicare covers a different 15 and explicitly refuses to pay for two the FDA cleared. And “FDA approved” is the wrong phrase entirely: hyperbaric chambers are Class II devices cleared through 510(k), which reviews the equipment, not the therapy.

Search this question and you will get a different number almost every time. Published sources variously claim eleven, twelve, thirteen, fourteen, fifteen, or sixteen conditions, and most of them attribute the figure to the FDA regardless of which organization actually produced the list they are reproducing.

The confusion is not really about counting. It comes from three different bodies maintaining three different lists for three different purposes, and from a regulatory vocabulary in which “cleared,” “approved,” and “covered” mean genuinely different things. This guide separates them, gives each list in full with its source, and explains why they disagree.

Disclosure: Superhuman Chambers manufactures and sells hyperbaric chambers for wellness operators and home use. This article summarizes public regulatory information and is not medical or legal advice. Regulatory status varies by country, and operators are responsible for the claims, protocols, and compliance obligations in their own jurisdiction.

Three lists, three organizations, three purposes

Most of the disagreement about “how many conditions” disappears once you notice that three separate bodies maintain three separate lists.

These lists were built by different organizations, at different times, to answer different questions. A regulator asking whether a device may be sold, a medical society asking what the evidence supports, and an insurer asking what it will reimburse are not going to arrive at the same answer, and they have not. Conflating any two of them produces a number that is wrong for both.

The 13 conditions the FDA has cleared

The FDA’s list covers 13 conditions and has not changed since 2013.

As of its last published version, the FDA had cleared hyperbaric chambers for marketing in the following conditions:

1. Air and gas bubbles in blood vessels
2. Anemia (severe anemia when blood transfusions cannot be used)
3. Burns (severe and large burns treated at a specialized burn center)
4. Carbon monoxide poisoning
5. Crush injury
6. Decompression sickness (diving risk)
7. Gas gangrene
8. Hearing loss (complete hearing loss that occurs suddenly and without any known cause)
9. Infection of the skin and bone (severe)
10. Radiation injury
11. Skin graft flap at risk of tissue death
12. Vision loss (when sudden and painless in one eye due to blockage of blood flow)
13. Wounds (non-healing, diabetic foot ulcers)

The agency stated alongside this list that it had not cleared or authorized hyperbaric devices for any condition beyond those listed.

A note on sourcing this list

The FDA page that carried this list is no longer available. Hyperbaric Oxygen Therapy: Get the Facts was live as recently as December 2025 and now returns a 404, with no replacement page enumerating the indications anywhere on fda.gov. Archived copies remain accessible and the page carried a “content current as of 07/26/2021” timestamp.

This is worth knowing because a great many articles, including reference lists at major medical institutions, still cite that URL as their authority. The only HBOT page currently live on fda.gov is an August 2025 letter to health care providers about fire safety, which enumerates no indications at all. It does confirm the regulatory basics: HBOT devices are Class II and are cleared through the 510(k) process under product code CBF.

Cleared is not approved, and the difference is not pedantic

The FDA cleared the chamber, not the therapy, and it did so without necessarily reviewing whether the therapy works.

Hyperbaric chambers are Class II devices regulated under 21 CFR 868.5470, and they reach the market through 510(k) premarket notification. That pathway asks a comparative question: is this device substantially equivalent to a device already legally on the market? It does not ask whether the treatment produces a clinical benefit. In the FDA’s own words, the agency “does not require clinical data in most 510(k)s.”

Premarket approval (PMA), the pathway that earns the word “approved,” is a different and far more demanding process reserved for Class III devices, requiring valid scientific evidence of safety and effectiveness. Hyperbaric chambers have never gone through it.

So “FDA approved” compresses three errors into two words. The verb is wrong, because Class II devices are cleared. The object is wrong, because clearance attaches to a piece of equipment rather than to hyperbaric oxygen therapy as a treatment. And the implication is wrong, because it suggests the FDA weighed efficacy evidence it very likely never required. The accurate formulation is that the FDA has cleared hyperbaric chambers for marketing for use in 13 conditions.

The UHMS list: 15 approved indications

The Undersea and Hyperbaric Medical Society maintains the clinical list, which currently runs to 15 numbered indications.

The UHMS is the professional society for hyperbaric medicine, and its Hyperbaric Medicine Indications Manual, now in its 15th edition (2023), is what hyperbaric physicians actually work from. Its list reflects a judgment about evidence rather than a marketing authorization.

1. Air or gas embolism
2. Carbon monoxide poisoning (including cases complicated by cyanide poisoning)
3. Clostridial myositis and myonecrosis (gas gangrene)
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness
6. Arterial insufficiencies: central retinal artery occlusion, and enhancement of healing in selected problem wounds
7. Severe anemia
8. Intracranial abscess
9. Necrotizing soft tissue infections
10. Refractory osteomyelitis
11. Delayed radiation injury (soft tissue and bony necrosis)
12. Compromised grafts and flaps
13. Acute thermal burn injury
14. Idiopathic sudden sensorineural hearing loss
15. Avascular necrosis (aseptic osteonecrosis)

Two items are recent additions. Sudden sensorineural hearing loss was ratified by the UHMS board in October 2011. Avascular necrosis was added in the 15th edition in 2023, which is the most recent change to any of these lists.

You will still frequently see “14” cited as the UHMS number. That figure predates the 2023 addition, and the society’s own registry page has not been updated, which is very likely why the outdated count keeps circulating. The current list has 15 numbered indications. You may also see the list rendered as 17 bullet points, which happens because two numbered indications carry sub-items rather than because there are 17 separate conditions.

Medicare covers a third, different list

Medicare’s list overlaps the other two but was built independently, and it explicitly refuses two conditions the FDA cleared.

Coverage runs through National Coverage Determination 20.29, whose clinical content has been unchanged since April 2017 and whose covered and non-covered lists date back to 2003. Medicare covers 15 conditions: acute carbon monoxide intoxication, decompression illness, gas embolism, gas gangrene, acute traumatic peripheral ischemia, crush injuries and suturing of severed limbs, progressive necrotizing infections, acute peripheral arterial insufficiency, preparation and preservation of compromised skin grafts, chronic refractory osteomyelitis, osteoradionecrosis, soft tissue radionecrosis, cyanide poisoning, actinomycosis, and diabetic lower-extremity wounds meeting specific criteria.

The diabetic wound category carries the tightest conditions of any entry: the wound must be Wagner grade III or higher, must have failed an adequate course of standard wound therapy, and treatment stops being covered if no measurable healing appears within any 30-day period.

The instructive part is where Medicare parts company with the other two lists:

• Thermal burns are FDA-cleared and UHMS-approved, and appear on Medicare’s explicitly non-covered list.
• Severe blood loss anemia is likewise FDA-cleared and UHMS-approved, and also explicitly non-covered.
• Actinomycosis and acute peripheral arterial insufficiency are covered by Medicare but appear on neither of the other lists.
• Hearing loss, vision loss, intracranial abscess, and avascular necrosis are absent from Medicare’s list, and the first two are FDA-cleared.

Medicare also names 22 conditions it will not pay for, among them multiple sclerosis, Alzheimer’s disease, senility, arthritic diseases, sickle cell anemia, and cerebral edema. A frequent misstatement is that cerebral palsy appears on this list. It does not, in any version of the NCD.

Reading the three lists side by side

Laid out together, the disagreements turn out to be mostly definitional rather than medical.

Most of the numeric gap between 13 and 15 is bookkeeping. The FDA folds necrotizing soft tissue infections and refractory osteomyelitis into a single entry (“infection of the skin and bone”), while the UHMS numbers them separately. The genuine substantive differences are just two: intracranial abscess and avascular necrosis are UHMS indications the FDA list does not carry, the latter because it was added two years after the FDA last published.

Where soft-shell chambers sit

Portable and soft-shell chambers hold clearances for acute mountain sickness, which is a narrower authorization than the clinical list above.

The FDA applies the same product code, the same regulation, and the same Class II pathway to a hospital multiplace chamber and to a portable low-pressure chamber. It does not regulate by shell material or by pressure rating. The line it draws is the cleared indication. Reviewing the 510(k) record for portable and soft chambers, the cleared indication is consistently acute mountain sickness, descending from the original Gamow bag clearance in 1988 through to a 2023 clearance for a chamber rated at 1.3 to 1.5 ATA.

This is a factual boundary rather than a criticism of the category. Mild soft-shell chambers such as our Superhuman S1 have real uses at 1.3 to 1.5 ATA, and the clinical indications on the FDA and UHMS lists were studied at substantially higher pressures, typically 2.0 ATA and above, on hard-shell equipment like the Superhuman L1. Knowing which category a chamber belongs to, and what it is cleared for, matters more than the marketing label attached to it — a distinction worth keeping in mind when browsing hyperbaric chambers for sale. Our guide to hard-shell versus soft-shell chambers covers the engineering difference, and the hyperbaric chamber safety pillar covers the separate certification chain that governs the equipment itself.

Off-label use: what it does and does not permit

A physician may lawfully use a cleared device off-label, but a manufacturer may not market it for uses it was not cleared for, and that asymmetry is the crux for operators.

The FDA does not regulate the practice of medicine. A licensed physician who judges a cleared device appropriate for a patient may use it outside its cleared indications, and no FDA authorization or ethics review is required when this is treatment rather than research. That is why hyperbaric clinics can and do treat conditions absent from all three lists.

Marketing is governed differently. Under 21 CFR 801.4, a device’s “intended use” is established by the objective intent of whoever is responsible for its labeling, and that intent can be demonstrated through labeling claims, advertising, or written and oral statements. Promotional claims therefore define the intended use as a matter of law. Advertise a chamber for a condition it was not cleared for, and the marketing itself creates an uncleared intended use.

For a wellness operator the practical distinction is this: what a physician may do under their own license is not the same as what a facility may advertise. An operator making public claims about conditions outside the cleared indications is on materially different ground than a physician exercising clinical judgment, and being deliberate about that line protects the business as much as the client.

Limitations and what these lists do not tell you

These lists answer narrower questions than they are usually asked to answer.

• A cleared indication is not proof of efficacy. 510(k) clearance rests on equivalence to a predicate device, and in most cases no clinical data were required.
• Clearance does not imply coverage. Burns and severe anemia are cleared and approved, and Medicare pays for neither.
• The FDA list is dated and its source page is gone. It has been unchanged since 2013, was last published in 2021, and has never reflected the 2023 UHMS addition.
• Medicare’s list is roughly two decades old. Its covered and non-covered lists have been substantively unchanged since 2003.
• Absence from a list is not evidence of harm or of failure. It frequently means nobody has run the trials, or that no manufacturer has sought clearance for that use.
• This is US-specific. European and other national bodies maintain their own, longer lists, and regulatory status does not transfer across borders.

What this means for wellness operators

For operators, these three lists are less a marketing asset than a vocabulary to get right.

First, use the correct verb. Say cleared when you mean cleared, covered when you mean covered, and name the body behind any number you cite. Saying “the FDA has cleared hyperbaric chambers for 13 conditions, and the UHMS recognizes 15” is both accurate and more credible than a bare “FDA approved.”

Second, know which list your equipment and your claims belong to. A chamber’s clearance, its pressure rating, and the indications you discuss publicly should be consistent with one another. If your program runs mild soft-shell equipment for general wellness, the clinical indications list is not describing what you operate.

Third, treat coverage as a separate question. Clients routinely assume that a cleared condition means an insured one. Being the operator who explains that burns are cleared but not covered by Medicare is a trust-building conversation rather than a lost sale.

For related reading, our guides to HBOT side effects and contraindications and hyperbaric chamber pressure levels cover the screening and dosing side. To talk through how an evidence-first hyperbaric program should be positioned, you can learn more about Superhuman or contact the team.

References

1. US Food and Drug Administration. Hyperbaric Oxygen Therapy: Get the Facts. Consumer Update, content current as of 26 July 2021. Page withdrawn from fda.gov between December 2025 and January 2026; archived copies remain available.
2. US Food and Drug Administration. Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices: Letter to Health Care Providers. 25 August 2025.
3. US Food and Drug Administration. Is It Really “FDA Approved”? Consumer Update.
4. US Food and Drug Administration, CDRH/CBER. Frequently Asked Questions About Medical Devices: Information Sheet Guidance. January 2006.
5. 21 CFR 868.5470, Hyperbaric chamber. Code of Federal Regulations.
6. 21 CFR 801.4, Meaning of intended uses. Code of Federal Regulations, as amended 86 FR 41401 (2 August 2021).
7. Huang ET, ed. UHMS Hyperbaric Medicine Indications Manual. 15th ed. North Palm Beach, FL: Best Publishing Company; 2023. ISBN 978-1-947239-42-5.
8. Undersea and Hyperbaric Medical Society. UHMS Approved Indications for Hyperbaric Oxygen Therapy.
9. Centers for Medicare & Medicaid Services. National Coverage Determination 20.29: Hyperbaric Oxygen Therapy. Medicare NCD Manual Pub. 100-03, Ch. 1 Part 1. Version 4, effective 3 April 2017.