FDA Approved Conditions we Help

How Does Hyperbaric Oxygen Therapy Work?

Hyperbaric Chamber Therapy, also known as recompression therapy, works by providing a controlled stream of oxygen, an essential element for human life. Oxygen is absorbed by the lungs, where it enters the bloodstream, travels to the heart, then circulates to all of the tissues in your body.

HBOT delivers pure oxygen under high air pressure, which helps the body take in more healing oxygen. This, in turn, allows for higher oxygen concentrations in the blood and other body fluids.

Oxygen-rich fluids travel through different organ systems, helping to repair damaged tissues.

The FDA has approved hyperbaric oxygen therapy (HBOT) for the following conditions.

The FDA Approved Conditions Treated by Hyperbaric Oxygen Therapy:

Hyperbaric Oxygen Therapy: Get the FDA Facts

The U.S. Food and Drug Administration (FDA) has approved Hyperbaric Oxygen Therapy (HBOT) for specific medical conditions where research has demonstrated its safety and effectiveness.

The FDA regulates both the oxygen used in HBOT and the hyperbaric chambers, which are generally a tube large enough to hold one person or a room that can accommodate more than one person. You can read more in their Website at this Link:

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. They are in the process of updating FDA.gov content to reflect these changes.

Hyperbaric Oxygen Therapy Approved by FDA

Hyperbaric Oxygen Therapy is well known for treating scuba and deep-sea divers affected by the rapid change in pressure around them. But did you know that HBOT is also used to treat a variety of other health problems, including carbon monoxide poisoning and diabetic foot ulcers?

If you are considering the use of a HBOT device for yourself or a loved one, be aware that some claims of what it can do are unproven. For example, HBOT devices are not proven to cure cancer, Lyme disease, autism or Alzheimer’s disease. The U.S. Food and Drug Administration recommends you check with your health care provider before using a HBOT device to make sure you are pursuing the most appropriate care. If your health care provider recommends HBOT, the FDA advises that you go to a hospital or facility that has been inspected and is properly accredited by the Undersea and Hyperbaric Medical Society

Hyperbaric oxygen therapy and the FDA’s role:

Our body’s tissues need oxygen to function. The air we breathe is 21% oxygen.  HBOT involves breathing 100% oxygen while in a special space called a hyperbaric chamber. The air pressure inside is raised to a level that is higher than normal air pressure. The increased air pressure in the chamber helps the lungs collect more oxygen. Getting more oxygen to the tissues that need it can help the body heal and fight certain infections. However, too much oxygen can cause damage to the body. The FDA regulates both the oxygen used in HBOT and the hyperbaric chambers, which are generally a tube large enough to hold one person or a room that can accommodate more than one person.

PLEASE NOTE: Risks of hyperbaric oxygen therapy

When HBOT chambers are used for indications cleared by the FDA, HBOT is generally safe, and serious complications are rare.Because of the increased pressure and increased concentration of the oxygen during HBOT, potential risks include:

  • Ear and sinus pain

  • Middle ear injuries, including tympanic membrane rupture

  • Temporary vision changes

  • Lung collapse (rare)

High concentrations of oxygen also pose the risk of fire, which is one reason why the FDA recommends treatment at an accredited facility.  Explosions and fires have occurred in HBOT chambers that have not been reviewed by the FDA and are located at unaccredited facilities.

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.

Additional Information: If you have experienced serious health or safety problems related to HBOT, you can voluntarily report them to MedWatch, the FDA safety information and adverse event reporting program.

The Top 12 Benefits of NOVA HBOT include: