Hyperbaric oxygen therapy marketing: FDA cleared uses, Medicare coverage and claims

A hyperbaric oxygen therapy center answers three different questions every time it writes a condition page: what FDA has cleared hyperbaric chambers for, what Medicare will pay for, and what the center can support with evidence in an ad. The three lists do not match. A condition can be on FDA’s list and outside Medicare’s, on Medicare’s list and missing from FDA’s consumer list, or on neither and still show up in a wellness clinic’s menu. This guide sets the lists side by side and explains how to write pages that stay inside them.

Referral marketing, offers to patients, Medicare’s three criteria for diabetic wounds of the lower extremities and wound photos are covered in our guide to wound care marketing ideas, so they are not repeated here. Claims made for devices in general are covered in medical device marketing claims, and patient stories in patient testimonials and before-and-after photos.

What FDA has cleared hyperbaric chambers for

FDA regulates both the oxygen used in hyperbaric oxygen therapy and the chambers. Under 21 CFR 868.5470, a hyperbaric chamber is a device intended to increase the environmental oxygen pressure to promote the movement of oxygen from the environment to a patient’s tissue by means of pressurization greater than atmospheric pressure, and it is a Class II device. FDA’s August 2025 letter to health care providers says these devices are cleared through the 510(k) process and that cleared devices can be found by searching for product code CBF in FDA’s 510(k) database.

FDA’s consumer update explains that clearance includes a determination that the device has the same intended use as, and is as safe and effective as, another legally marketed device of that type. It then lists the disorders for which FDA had cleared hyperbaric chambers as of July 2021:

• 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)

The update adds that FDA had not cleared or authorized the use of any hyperbaric device to treat COVID-19 or any conditions beyond those listed. Two dating notes matter for anyone who copies this list. The page says content current as of July 26, 2021, and as of our check on October 29, 2026, FDA no longer serves it at its original address. Use it as FDA’s last published consumer list, with that date next to it, and for a specific chamber ask the manufacturer for the cleared indications in its own labeling.

What FDA said is not proven

The same consumer update warns that some claims of what hyperbaric therapy can do are unproven, and gives examples: FDA says hyperbaric devices are not proven to cure cancer, Lyme disease, autism or Alzheimer’s disease. It recommends checking with a health care provider before using a hyperbaric device, and, if a provider recommends it, going to a hospital or facility that has been inspected and is properly accredited for hyperbaric medicine.

A physician may decide to treat a patient for a condition that is not on FDA’s list. That is a clinical decision. A web page that names the condition next to the word hyperbaric is something else: it is an advertising claim, and it is judged under the FTC Act, not under the physician’s judgment about one patient.

Section 5 of the FTC Act, 15 U.S.C. 45, prohibits deceptive acts or practices, and section 12, 15 U.S.C. 52, makes it unlawful to disseminate a false advertisement likely to induce the purchase of drugs, devices or services. The FTC Health Products Compliance Guidance says health benefit claims need competent and reliable scientific evidence, that randomized, controlled human clinical trials are generally the type experts would require, and that advertisers are responsible for claims a reasonable consumer would take from the ad as a whole, including implied ones. A list of conditions under a heading such as what we treat implies that the treatment works for each of them.

Cleared is not covered: Medicare’s list

Medicare.gov says Part B may cover hyperbaric oxygen therapy if the patient gets it in a chamber, including a one-person unit, and has one of the conditions it lists. National Coverage Determination 20.29 is the policy behind that page. Its covered list:

• Acute carbon monoxide intoxication
• Decompression illness
• Gas embolism
• Gas gangrene
• Acute traumatic peripheral ischemia, as an adjunct to standard treatment when loss of function, limb or life is threatened
• Crush injuries and suturing of severed limbs, on the same adjunctive basis
• Progressive necrotizing infections (necrotizing fasciitis)
• Acute peripheral arterial insufficiency
• Preparation and preservation of compromised skin grafts (not for primary management of wounds)
• Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management
• Osteoradionecrosis and soft tissue radionecrosis, as an adjunct to conventional treatment
• Cyanide poisoning
• Actinomycosis, only as an adjunct when the disease is refractory to antibiotics and surgical treatment
• Diabetic wounds of the lower extremities in patients who meet three criteria, explained in our wound care guide

The NCD then says all other indications are not covered and that no program payment may be made for any conditions other than those listed. It also names conditions for which no payment may be made, among them cutaneous, decubitus and stasis ulcers; chronic peripheral vascular insufficiency; skin burns (thermal); sickle cell anemia; exceptional blood loss anemia; acute or chronic cerebral vascular insufficiency; nonvascular causes of chronic brain syndrome, including Alzheimer’s disease; multiple sclerosis; arthritic diseases; and acute cerebral edema.

Set beside FDA’s consumer list, the gaps are plain. FDA’s list includes severe burns treated at a specialized burn center and severe anemia when transfusions cannot be used, while the NCD lists thermal skin burns and exceptional blood loss anemia among conditions it will not pay for. FDA’s list includes sudden hearing loss and sudden vision loss from blocked blood flow, which are not on Medicare’s covered list. Medicare’s list includes cyanide poisoning and actinomycosis, which are not on FDA’s consumer list. The NCD also notes that topical oxygen for chronic non-healing wounds was removed from it effective April 3, 2017, and that Medicare Administrative Contractors may determine coverage of topical oxygen in their own jurisdictions.

So a page that says hyperbaric therapy is covered by Medicare, with no condition attached, is inaccurate for every condition outside the NCD. Name the condition, say that coverage depends on Medicare’s criteria, link to Medicare.gov, and say that your staff checks coverage before treatment starts. On cost, Medicare.gov describes the patient’s share for this Part B service in terms of the Medicare-approved amount and the Part B deductible, and says the specific amount depends on other insurance, what the doctor charges, whether the doctor accepts assignment, the type of facility and where the service is given. Repeat that framing rather than a flat price promise.

Soft chambers and wellness settings

FDA’s consumer update describes one other kind of hyperbaric device: a large, zippered bag that FDA has cleared to treat altitude sickness only. FDA says these bags provide pressure but do not attach to oxygen tanks, that it has not cleared them for use with oxygen tanks or oxygen concentrators, and that it is aware of people using them to create homemade hyperbaric oxygen devices, which can pose the risk of fire and suffocation.

For a wellness clinic or spa with a soft chamber, that has two consequences for marketing. First, the FDA cleared conditions in the list above are for hyperbaric chambers that deliver oxygen under pressure, so a page about sessions in a soft chamber should not borrow that list. Second, a page that describes a soft chamber session as hyperbaric oxygen therapy, or pictures one connected to an oxygen source, describes a use FDA says it has not cleared. Describe the device you have and the use it is cleared for, in the words of its labeling.

Safety statements on your site

FDA’s consumer update says that when hyperbaric chambers are used for indications cleared by FDA, the therapy is generally safe and serious complications are rare, and lists potential risks: ear and sinus pain, middle ear injuries including tympanic membrane rupture, temporary vision changes, and, rarely, lung collapse. It adds that high concentrations of oxygen pose the risk of fire, which is one reason FDA recommends treatment at an accredited facility.

FDA’s August 25, 2025 letter to health care providers says FDA is aware of reports of fires with hyperbaric devices that resulted in serious injuries and deaths, that the root cause was not known at the time, and that while FDA believes serious adverse events are rare, they can and do occur. It recommends that providers and facilities:

• Review and follow the manufacturer’s instructions for use for each device.
• Follow fire prevention and safety measures, be aware of the heightened fire risk with high concentration oxygen, and use proper grounding equipment.
• Provide and maintain proper training for staff.
• Monitor and supervise the patient for the duration of the treatment.
• Follow the manufacturer’s cleaning procedures, maintenance intervals and safety checks.
• Follow the manufacturer’s instructions on prohibited items, including electrical or static devices.
• Have patients wear clothing made of hyperbaric compatible materials, such as cotton, as the manufacturer’s instructions describe.

A safety section on your website can describe the steps your facility takes, such as who supervises each treatment, what staff training covers, what patients wear and what they may not bring into the chamber, as long as every statement is true for your center and you can show it. Leave out words such as completely safe, no risk or no side effects; FDA’s own pages list risks, and an absolute safety claim is a health claim that needs the same evidence as any other.

Writing condition pages and ads

A condition page that stays inside these rules has a few parts. It names the condition in the terms FDA or Medicare uses, says that hyperbaric therapy for it is given as your physicians prescribe, describes the treatment process (the evaluation, what a session involves, how the team monitors the patient), states the coverage position with a link to Medicare.gov, and says who to call. It does not state a number of sessions that will produce a result, a success rate, or a promise such as avoid amputation or restore hearing.

Patient stories need care. Under 16 CFR 255.2(b), an advertisement that conveys an endorser’s experience with a key attribute is likely to be read as showing what consumers will generally achieve, so unless the advertiser has adequate substantiation that the experience is representative, the ad should clearly and conspicuously disclose the generally expected performance. Our testimonials guide covers the authorization and consent steps.

For conditions outside FDA’s list and outside Medicare’s, the safer course is to leave them off marketing pages and ads altogether. If your physicians offer treatment for such a condition, they can discuss it with patients during an evaluation, where the discussion is about one patient and the evidence for them, rather than in an ad addressed to everyone.

Illustration: a freestanding hyperbaric center

Illustration: a freestanding center runs a multiplace chamber and takes physician referrals. Its old site has one page, titled conditions we treat, with a long list that mixes FDA cleared uses, conditions Medicare will not pay for, and several that FDA’s consumer update calls unproven, under a banner reading covered by Medicare.

A rebuilt site splits that page by the conditions the center’s physicians actually treat. Each page uses the FDA or Medicare wording, explains the evaluation and the session, and gives the coverage position for that condition with a link to Medicare.gov. The conditions FDA calls unproven are gone from the site. The banner is replaced by a line saying the staff checks Medicare and other insurance coverage before treatment. A safety page describes the center’s supervision, training and clothing rules, drawn from its own procedures. Ads point to the condition pages that match the search, not to a general list.

Checklist

• Each condition page matches FDA’s cleared list or Medicare’s covered list, with the source and date noted in your records.
• The chamber’s own cleared indications, from its labeling or 510(k) record, are on file.
• No page or ad claims hyperbaric therapy cures or treats cancer, Lyme disease, autism or Alzheimer’s disease.
• No conditions outside both lists on marketing pages or ads.
• Coverage wording names the condition and links to Medicare.gov; no blanket covered by Medicare banner.
• No success rates, session counts tied to results, or absolute safety claims (15 U.S.C. 45, 52; FTC Health Products Compliance Guidance).
• Soft chambers described only for the use FDA cleared, never as oxygen therapy.
• Safety statements describe real procedures your center follows, consistent with FDA’s August 2025 letter.
• Patient stories meet 16 CFR 255.2(b) and the consent steps in our testimonials guide.

How we help

We build websites, local search, Google Ads and AI front desk tools for independent practices. For a hyperbaric center, we can build condition pages on your medical website that use FDA and Medicare wording with dated sources, a coverage section that links to Medicare.gov instead of promising payment, and campaigns that point each search to the page that matches it. Your physicians decide which conditions you treat; we write about those and leave the rest off the page. Our AI front desk is built with HIPAA in mind and can answer questions about hours, locations, what to wear and how to book from a list you approve, passing clinical and coverage questions to your staff. We confirm in writing what a BAA covers before any patient information flows through a tool, and if it is not covered, we do not route patient information through it. We do not sell lead lists and do not pay for referrals. For the wider set of rules we follow, see our healthcare marketing rules hub.

Sources

• FDA consumer update: Hyperbaric Oxygen Therapy: Get the Facts (content current as of July 26, 2021; archived copy of December 18, 2025)
• FDA: Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices, Letter to Health Care Providers (August 25, 2025)
• 21 CFR 868.5470: Hyperbaric chamber
• Medicare.gov: Hyperbaric oxygen therapy coverage
• CMS: National Coverage Determination 20.29, Hyperbaric Oxygen Therapy
• 15 U.S.C. 45: Unfair methods of competition unlawful; prevention by Commission
• 15 U.S.C. 52: Dissemination of false advertisements (FTC Act section 12)
• FTC: Health Products Compliance Guidance (December 2022)
• 16 CFR 255.2: Consumer endorsements

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