FDA Disclaimer

Currently, the FDA recognizes hyperbaric oxygen therapy for 14 different conditions.

Conditions for which hyperbaric chambers are cleared for marketing by the FDA

FDA clearance of a medical device includes a determination that the device has the same intended use as, and is as safe and effective as, another legally U.S.-marketed device of that type. As of July 2021, the FDA has cleared hyperbaric chambers for the following disorders:

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

HBOT is being studied for other conditions, including COVID-19. However, at this time, the FDA has not cleared or authorized the use of any HBOT device to treat COVID-19 or any conditions beyond those listed above. The website, clinicaltrials.gov, has more information on HBOT clinical trials for COVID-19 and other conditions.

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