Cleared Indications
Conditions Hyperbaric Oxygen Therapy Is Cleared For, and How Physicians Decide
Hyperbaric oxygen therapy is cleared by the FDA and recognized by the Undersea and Hyperbaric Medical Society for a specific, published list of conditions, not for everything you may see advertised. Some are outpatient indications a physician can evaluate at our Modesto center. Others are emergencies handled in hospital chambers.
The Official Lists
The FDA-Cleared and UHMS-Recognized Indications
Three bodies publish lists of conditions for hyperbaric oxygen therapy (HBOT). The FDA clears hyperbaric chambers for 14 conditions. The Undersea and Hyperbaric Medical Society (UHMS) recognizes 15 indications in its 15th edition, which added avascular necrosis. Medicare's National Coverage Determination 20.29 covers 15 conditions when set criteria are met. The lists overlap a great deal, but they are not identical, so the table below shows each one side by side.
The "Typical setting" column describes where each condition is usually managed. It is a general fact about hyperbaric medicine, not a claim about which conditions any one center accepts.
| Indication | FDA-cleared | UHMS | Medicare NCD 20.29 | Typical setting |
|---|---|---|---|---|
| Selected diabetic foot ulcers and problem wounds | Yes (diabetic lower-extremity wounds) | Yes | Yes, with criteria | Outpatient |
| Delayed radiation injury (soft tissue and bone) | Yes | Yes | Yes, as an adjunct | Outpatient |
| Compromised skin grafts and flaps | Yes | Yes | Yes | Outpatient, time-sensitive |
| Chronic refractory osteomyelitis | Yes | Yes | Yes | Outpatient |
| Sudden sensorineural hearing loss | Yes | Yes | Not listed | Outpatient, time-critical |
| Avascular necrosis | Not listed | Yes (new in 15th ed.) | Not listed | Specialist-directed, case by case |
| Carbon monoxide poisoning | Yes | Yes | Yes | Hospital emergency |
| Decompression sickness | Yes | Yes | Yes | Hospital emergency |
| Air or gas embolism | Yes | Yes | Yes | Hospital emergency |
| Crush injury, compartment syndrome, acute traumatic ischemia | Yes | Yes | Yes | Hospital emergency |
| Necrotizing soft-tissue infections | Yes | Yes | Yes | Hospital emergency |
| Gas gangrene (clostridial myonecrosis) | Yes | Yes | Yes | Hospital emergency |
| Acute thermal burns | Yes | Yes | Not covered | Hospital burn center |
| Severe anemia | Yes | Yes | Not covered | Hospital |
| Intracranial abscess | Yes | Yes | Not listed | Hospital |
| Central retinal artery occlusion | Not listed | Yes | Not listed | Hospital emergency |
Medicare's list also includes a few items that appear under different names elsewhere: cyanide poisoning, actinomycosis (as an adjunct), and acute peripheral arterial insufficiency. For Medicare's exact wording and criteria, read Medicare-covered HBOT conditions.
What "FDA-cleared" means, and why "approved" is the wrong word
The FDA regulates hyperbaric chambers as medical devices. It clears a chamber for specific uses, one indication at a time. It does not approve "HBOT" as a general treatment for anything. So the accurate phrase is "an FDA-cleared indication for hyperbaric oxygen therapy." The FDA also advises patients to receive HBOT under a doctor's care at an accredited facility, and warns consumers about centers that advertise uses outside the cleared list.
Pressure matters too. The UHMS defines HBOT as breathing near-100% oxygen in a chamber pressurized to at least 1.4 times normal atmospheric pressure (1.4 ATA), and every UHMS-recognized indication calls for 2.0 ATA or more.
At Generations Wellness
Outpatient Indications Our Physician Evaluates
Generations Wellness is an outpatient center in downtown Modesto. Care is directed by Dr. Rajwinder Singh Bahia, MD, and sessions take place in hard-shell monoplace chambers, where you breathe medical-grade oxygen at a physician-prescribed pressure. The cleared indications that fit an outpatient, by-appointment setting are the ones our physician evaluates:
- Diabetic foot ulcers. HBOT may support healing in selected deep ulcers that have not improved with standard wound care.
- Non-healing wounds. Which chronic wounds are cleared categories, and which are not.
- Chronic refractory osteomyelitis. Used as an adjunct to surgery and antibiotics for bone infection that keeps returning.
- Delayed radiation injury. Including osteoradionecrosis of the jaw, radiation cystitis and proctitis, and soft-tissue damage.
- Compromised skin grafts and flaps. A time-sensitive adjunct to your surgeon's care.
- Sudden sensorineural hearing loss. Considered alongside steroids from your ear, nose and throat doctor, within guideline time windows.
Each page explains how HBOT may support healing, who may be a candidate, what the research shows (including its limits), what a course looks like, and how coverage works. For the broader picture of who HBOT may help, see who HBOT may help.
Emergencies
Emergency Indications: Call 911
Carbon monoxide poisoning, decompression sickness, air or gas embolism, necrotizing soft-tissue infections, gas gangrene, crush injuries, severe anemia, central retinal artery occlusion and acute burns are medical emergencies. If you or someone near you may have one of these, call 911 or go to the nearest emergency room. For suspected poisoning, California Poison Control is available at 1-800-222-1222.
Emergency hyperbaric treatment is delivered at hospital-based chambers, alongside emergency and critical care teams. Generations Wellness is an outpatient center and does not provide emergency hyperbaric treatment. Our educational pages on these conditions explain what each one is and why hospitals may use HBOT, so that you and your family understand the care you may receive elsewhere.
Honest Limits
What HBOT Is Not Cleared For
The FDA states that HBOT is not cleared for cancer, autism, Lyme disease, Alzheimer's disease, stroke, brain injury, cerebral palsy, multiple sclerosis, Parkinson's disease, depression, migraine, heart disease, asthma, HIV/AIDS, sports injuries or COVID-19. Wellness claims such as anti-aging or faster athletic recovery are not on any cleared or recognized list either.
Some of these topics are being studied, and a few early studies are interesting. Still, none is a cleared indication today, and Generations Wellness does not market HBOT for them. If you want to understand what the studies do and do not show, read what the evidence says about non-cleared uses.
Candidacy
How Our Physician Decides Whether HBOT Is Appropriate
- The indication. Is your diagnosis on the cleared or recognized list, and is it a condition suited to outpatient care?
- The criteria. Many indications have conditions attached, such as a wound grade, time on standard care, or a time window after symptoms began.
- A safety screen. Lungs, ears and sinuses, medications and implanted devices are reviewed. See contraindications and screening.
- Coordination with your doctors. With your permission, we work with the doctors already treating you so HBOT fits their plan.
You don't need a referral to call us, though many patients come with one. Doctors who want to discuss a patient can refer a patient. On payment: Generations Wellness currently offers HBOT on a self-pay basis and does not bill insurance or Medicare. Coverage elsewhere depends on the indication and criteria, which we explain in which indications insurance may cover.
Important
A physician assessment is required before beginning HBOT at Generations Wellness. HBOT complements, and never replaces, the treatment prescribed by your doctors.
Questions
Cleared Conditions: Frequently Asked Questions
What conditions are FDA-cleared for HBOT?
The FDA has cleared hyperbaric chambers for 14 conditions. They include select diabetic lower-extremity wounds, delayed radiation injury, compromised grafts and flaps, refractory osteomyelitis and sudden sensorineural hearing loss, plus emergencies such as carbon monoxide poisoning and decompression sickness.
Is HBOT FDA approved?
The FDA clears hyperbaric chambers as medical devices for specific indications. It does not approve HBOT in general, and it has not cleared HBOT for many conditions marketed elsewhere.
Do I need a doctor's referral?
Not to call us. A physician assessment at our center is required before any course, and with your permission we coordinate with your treating doctor.
Is my condition managed here or at a hospital?
Emergency indications are handled in hospital chambers, so call 911 for those. Wound, radiation injury, graft and flap, bone infection and sudden hearing loss indications can be evaluated at our Modesto center.
Does Generations Wellness accept insurance for these conditions?
Not currently. We offer HBOT on a self-pay basis while we work toward insurance contracts. Ask us and we'll explain your options honestly, including when coverage elsewhere may make more sense.
Sources
- U.S. Food and Drug Administration. Hyperbaric Oxygen Therapy: Get the Facts. fda.gov
- Undersea and Hyperbaric Medical Society. Hyperbaric Oxygen Therapy Indications. uhms.org
- Centers for Medicare & Medicaid Services. National Coverage Determination 20.29, Hyperbaric Oxygen Therapy. cms.gov
- American College of Emergency Physicians. Announcing HBO's Newest Indication: Avascular Necrosis. acep.org
- Undersea and Hyperbaric Medical Society. Position Statement on Low-Pressure Fabric Hyperbaric Chambers. uhms.org
This page is educational and not medical advice. In an emergency, call 911. A physician assessment is required before HBOT. See our full medical disclaimer.
In This Section
Conditions HBOT Is Cleared For
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Carbon Monoxide Poisoning and HBOT
Carbon monoxide poisoning is a 911 emergency treated at hospital hyperbaric chambers. Who gets HBOT, how many sessions, and what the evidence shows.
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Crush Injury and Acute Traumatic Ischemia
Crush injury and compartment syndrome are surgical emergencies. Where HBOT fits as a hospital adjunct, what the one RCT found, and the outpatient role.
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Decompression Sickness (The Bends)
Decompression sickness is treated by recompression at a hospital or DAN-referred chamber, not an outpatient clinic. What treatment involves; call 911, DAN.
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HBOT for Diabetic Foot Ulcers
HBOT may support healing in selected Wagner grade 3+ diabetic foot ulcers. When physicians consider it, the evidence, and how a course works in Modesto.
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Gas Embolism, Severe Anemia, CRAO and Brain Abscess
Four hospital-only HBOT indications explained: air or gas embolism, severe blood-loss anemia, central retinal artery occlusion, brain abscess. Call 911.
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Necrotizing Fasciitis and Gas Gangrene
Necrotizing infections are surgical emergencies; HBOT is a hospital adjunct after surgery and antibiotics. What the evidence shows; the later wound role.
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HBOT for Non-Healing Wounds
Why some wounds stall and how hyperbaric oxygen may support healing. Which chronic wounds are cleared indications, the evidence, and a course in Modesto.
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HBOT for Chronic Refractory Osteomyelitis
Hyperbaric oxygen for chronic bone infection that returns after antibiotics or surgery. Why oxygen matters, the evidence, sessions and coverage. Modesto.
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HBOT for Delayed Radiation Injury
Hyperbaric oxygen for delayed radiation injury: osteoradionecrosis, radiation cystitis and proctitis, soft-tissue damage and pre-extraction care. Modesto.
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HBOT for Compromised Skin Grafts and Flaps
When a skin graft or flap is failing, HBOT is an FDA-cleared adjunct. How it may support graft survival, timing, the evidence, and a course in Modesto.
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HBOT for Sudden Sensorineural Hearing Loss
Sudden sensorineural hearing loss is time-critical. When ENT guidelines say HBOT plus steroids may be offered, the evidence, sessions and coverage.
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Thermal Burns and HBOT
Severe burns are treated at burn centers. Thermal burns are a listed HBOT indication with limited evidence; scars are not. What is cleared and covered.
Your Next Step
Begin With a Physician Assessment
Every course starts with an honest conversation and a physician assessment. No pressure, no obligation.
Prefer to talk? (369) 222-0979