FDA Disclaimer

FDA clearance for a medical device signifies that the device is intended for the same purpose and meets safety and effectiveness standards comparable to an existing legally marketed device in the U.S. As of July 2021, hyperbaric chambers have received FDA clearance for treating the following conditions:

• Air or gas embolism (bubbles in blood vessels)
• Severe anemia when blood transfusion is not an option
• Extensive burns managed in specialized burn centers
• Carbon monoxide poisoning
• Crush injuries
• Decompression sickness (common in divers)
• Gas gangrene
• Sudden, unexplained hearing loss
• Severe skin and bone infections
• Radiation-induced tissue damage
• At-risk skin grafts or flaps
• Sudden, painless vision loss in one eye due to blocked blood flow
• Non-healing wounds, such as diabetic foot ulcers

Research is ongoing to evaluate HBOT for other uses, including COVID-19 treatment. However, the FDA has not yet approved or authorized any HBOT devices for COVID-19 or other conditions outside the ones listed. For updates on HBOT-related clinical trials, visit clinicaltrials.gov.