Understanding the benefits and risks of hyperbaric oxygen therapy

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?

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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.

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 , 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.

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.

Other hyperbaric devices

The FDA has also cleared a large, zippered bag that is intended to treat altitude sickness only.

These zippered chambers for treating altitude sickness provide pressure but do not attach to oxygen tanks. The FDA has not cleared these bags for use with oxygen tanks or oxygen concentrators. However, the FDA is aware of instances in which people used these bags to create homemade HBOT devices, which can pose the risk of fire and suffocation.

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.

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You might know that hyperbaric oxygen therapy (HBOT) can treat decompression sickness after deep-sea diving. But this therapy isn’t just for scuba divers. Many people can reap the benefits of HBOT, which can heal certain infections, skin wounds and complications from radiation therapy.

Here, Gary Reinheimer, M.D., a primary care physician at Henry Ford Health, explains hyperbaric oxygen therapy and how it can treat many conditions, including chronic wounds, bone infections and tissue damage.

Benefits Of Hyperbaric Oxygen Therapy

“Your skin and tissues have a remarkable ability to repair themselves, but they need an adequate blood supply to do it,” says Dr. Reinheimer. In order to recover, tissues need oxygen and nutrients, which are delivered in the blood. Hyperbaric oxygen therapy delivers 100% oxygen at high pressure to increase the amount of oxygen available in the tissues and stimulate new blood vessel growth.

“HBOT can heal wounds and tissue damage that have lingered for months or even years,” Dr. Reinheimer says. “In most cases, the healing effects of HBOT continue even after you’ve completed your treatment.”

What Does Hyperbaric Oxygen Therapy Treat?

Hyperbaric oxygen therapy is FDA-approved and covered by Medicare to treat many different health issues, including:

Diabetic foot ulcers

Ulcers (sores) and other wounds that won’t heal often respond well to HBOT. People with diabetes are especially prone to these chronic skin wounds. If your doctor has diagnosed you with a diabetic foot ulcer that is Wagner grade 3 or higher, HBOT may work for you.

“Diabetes can affect your immune system and your circulation, which leads to sores that can become serious,” says Dr. Reinheimer. “We’ve helped people avoid amputation from a skin wound that wouldn’t heal. If you’re facing a possible amputation, ask your provider if HBOT might be an option first.”

Delayed radiation injuries

Radiation is an important cancer treatment, but it can sometimes affect the surrounding tissue. HBOT can treat radiation damage after cancer treatment, including:

• Incomplete surgical healing affected by radiation therapy
• Osteoradionecrosis (bone healing problems)
• Radiation-induced cystitis (bladder inflammation)
• Radiation proctitis or enteritis (inflammation or infection in your rectum)
• Refractory osteomyelitis (bone infection that doesn’t respond to antibiotics)

Skin graft problems

If you have a skin graft or flap that isn’t “taking” or healing properly, HBOT can help. “A skin graft needs an adequate blood supply to fully heal,” says Dr. Reinheimer. “Hyperbaric oxygen therapy is often the extra boost that skin needs.”

Does Insurance Cover Hyperbaric Oxygen Therapy?

Many insurance companies, including Medicare, cover HBOT if you have a qualifying health condition. “We confirm insurance coverage for every patient before starting treatment,” Dr. Reinheimer says.

What Is Hyperbaric Therapy Like?

HBOT requires 30 to 60 treatments for effective results, each taking about two hours. “Hyperbaric therapy takes time, but the results can be life-changing,” says Dr. Reinheimer. “Most of our patients will say the healing effects were worth the commitment.”

Patients can watch TV or rest while the oxygen does its work. You may feel your ears pop inside the chamber as the pressure slowly increases. “Patients say it feels like being on an airplane, and it’s not painful,” says Dr. Reinheimer. “We make sure you feel comfortable throughout your therapy.”

Is Hyperbaric Therapy Right For You?

Like all medical treatments, HBOT has benefits and possible side effects, such as earache or temporary vision changes. “We talk with you about all the pros and cons of hyperbaric oxygen therapy so you can make an informed decision,” says Dr. Reinheimer. “You can also minimize side effects by going to a credible hyperbaric program overseen by an experienced, board-certified physician.”

Dr. Reinheimer and his team are passionate about hyperbaric therapy because they’ve seen the positive results. “Many of our patients achieve complete healing from ongoing health issues when they thought they had no options left,” he says. “Seeing them live a healthier life is so rewarding.”

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