How We Got Started: From Granddaughter's Ear Infections to Xlear

I studied history before I studied medicine. I learned there that people could respond to a particular challenge in a variety of ways. Medicine tends not to see that way; drugs need to be standard so the "average" person is who gets treated — but the average person does not exist. These two paths — history's appreciation for adaptation and medicine's search for the right intervention — converged when our granddaughter began having recurrent ear infections and Jerry said, "If you really cared about kids you would find a way to prevent ear infections."

History Before Medicine

Our treatments are often based on the wrong idea. I still remember walking down the hall of a hospital with the radiologist and his comment that we are still practicing humoral medicine. Humoral medicine focused on ways to restore the balance of symptoms; our focus is to restore the balance of our more scientifically defined symptoms. But often those symptoms are defenses that actually help us: fever, runny nose, and diarrhea all represent defenses that help us survive. Turning off these defenses with drugs is common practice today and balances symptoms — but when you hobble the defense of your favorite football team, they lose, and it is the same with us.

What is not seen is that the body shifts due to outside challenges. One shift I recognized early in practice was that nausea, vomiting, and diarrhea should not necessarily be stopped or balanced. Instead they should be seen as a defense that washes the irritant out of the body. Just as in a good soccer team, our defenses are strongest where we are most vulnerable: the openings to our bodies.

Oral rehydration was new when I began practicing medicine. It was used to treat cholera, which kills because it takes all of the body's water to wash out the cholera toxin. The mix of salt, sugar, and water in oral rehydration salts turns on the sodium-glucose transport pump in the stomach that pulls water into the body. I saw oral rehydration as an easy, safe, and effective way to optimize the backup defensive washing of the GI tract. Defenses such as these should not be treated — they should be honored and supported.

Jerry Bozeman and the Ear Infection Connection

Jerry came from a different direction. As an independent-minded teacher she migrated to areas where she was allowed more independence, eventually moving into special education. Early on she began to see a connection in her high-functioning students between their language problems and early childhood ear infections. Ear infections were then seen as a rite of passage — something babies and small children simply had to get through.

But every time a child has an ear infection, fluid sits in the middle ear where the ossicles carry sound vibrations to the brain, and fluid dampens those vibrations. When sounds are not clear, children do not make the right connections; learning language is handicapped. Jerry did not know the mechanism, but she knew the pattern. Over the last decade, physicians have recognized what Jerry saw many years ago. Jerome Klein, co-author of the standard medical text on otitis media in infants and children, lent support when he said, "This Jerry agrees with your Jerry."

The Granddaughter and the Tubes Conversation

These two paths met when our granddaughter began having recurrent ear infections and her doctor opened the subject of ventilation tubes. Jerry's response was direct: find a way to prevent ear infections rather than surgically bypass the problem.

I knew saline nasal sprays did not help much, but they were the only way available to help the nose wash itself out. I knew Tom Fleming, the person behind Ocean Nasal Spray. Tom had a packed single-spaced sheet of information about helpful things you could put in Ocean. I knew something else was needed to help nasal defenses work better. That is when I read about xylitol gum helping prevent ear infections — but our granddaughter was too young to chew gum. The xylitol in the gum worked on the bacteria, and the bacteria that cause ear infections are in the nose. It was not on Tom's list, but we decided to put it there.

Finnish Xylitol Gum and Ocean Nasal Spray

Matti Uhari and colleagues in Finland had demonstrated that xylitol chewing gum reduced acute otitis media by 42% in a double-blind randomized trial (PMID 8916743). The logic was straightforward: if xylitol reduces the bacteria in the mouth and nasopharynx that cause ear infections, delivering it directly to the nose should be even more effective — especially for infants who cannot chew gum.

We combined xylitol with the Ocean nasal spray base — saline with a delivery mechanism already familiar to patients and physicians. The resulting spray contained an 11% solution of xylitol with 0.65% saline, designed to stimulate the washing of the nasopharynx while reducing local pathogens. This work eventually led to the founding of Xlear, Inc., and the commercial availability of xylitol nasal spray.

Three Case Reports

The preventive value of the nasal spray is demonstrated in three case reports from my own practice.

Case H — Infant with Recurrent Otitis

H. was five months old when her parents placed her in day care. She was breast-fed until age two. Neither parents nor day-care workers smoked. Within two months of beginning day care, she had an ear infection that resolved with oral amoxicillin. But infections recurred, and within five months she had experienced four more. Learning problems are associated with recurrent ear infections in this critical period of life — problems that occur even when ear infections are treated appropriately, and ventilation tubes do not affect the learning problems.

Parents and day-care workers cooperated in washing H.'s nose every time they changed her diaper. She had no further ear infections until about six months later when a new day-care worker was not aware of the spraying routine. Reestablishing regular nasal washing resolved this problem without antibiotics. H. continued to use the spray regularly and had only two febrile episodes in the three years since beginning — far less than the six URIs per year described as normal for day-care children.

After this story appeared in a local paper, I had many similar children in my practice. Among ten of them, parents reported 43 ear infections in the five months before treatment (0.86 per month) and only 7 over an average of 11 months follow-up (0.06 per month).

Case B — Child with Severe Asthma

B. was eight years old when she came to my attention. She was receiving five different medications for her asthma, including regular nasal and frequent systemic steroids. She visited an emergency room about every six weeks. After hearing about the xylitol spray, her mother began spraying the child's nose regularly three times a day.

About a week later B. had an episode where material filling her nasopharynx broke loose, gagging her and causing distress. Her mother described it as a frightening experience, but the next week B. had no trouble with her asthma. A week later her mother stopped all asthma medications. Six months later B. was actively playing basketball and doing gymnastics without any trace of asthma. About two years after beginning the spray, she had experienced only one asthma attack and was no longer using the spray.

Case C — Adult with Diabetes and Asthma

C., aged 42, had diabetes and asthma for about 20 years. She had been receiving multiple medications for her asthma, including steroids that made her diabetes harder to manage. She had been hospitalized for asthma and related pulmonary infections an average of twice annually for the past ten years. She began using the spray regularly and in the ensuing year experienced no asthma and required no asthma medication. Her peak flow remained at 150–200 L/min for about six months but reached 350 L/min after a year of regular use.

Mucociliary Clearance and Nasal Defenses

Mucociliary clearance is the primary means of removing pollutants from the nasopharynx. Environmental factors affecting this mechanism are reflected in the incidence of problems. Cigarette smoke causes more problems because it is cilia-toxic. Most upper respiratory conditions occur in the fall, after the first cold spells — turning on central heat dries the air we breathe, making mucus drier and harder to clear.

The greatest incidence of otitis media in this country is among Native American people of Alaska. Healthcare workers reported these problems did not exist prior to becoming "civilized" — which included housing with central heat. Going from a winter dwelling where relative humidity is close to 100% to a home where it is closer to 20% was apparently too much for people who had otherwise adapted to their environment in a healthy way.

When pollution from allergens or pathogens exceeds what mucociliary clearance can handle, mast cells release histamine, tryptase, and other enzymes. Christer Svensson and colleagues described mucosal exudation of bulk plasma as a physiological airway tissue response with primarily a defense function (PMID 9517770). In commonsense terms, tryptase is the soap and histamine turns on the water for nasopharyngeal washing — the solution to pollution is dilution.

The 1970s Increases and the Antihistamine Problem

Upper respiratory problems have been increasing since the early 1970s. Documented by the National Center for Health Statistics for otitis and by the Centers for Disease Control for asthma, these conditions increased at about 5–6% per year since the 1970s. The parallel increases of both asthma and otitis — wholly different processes — suggest something they have in common. The nasopharynx appears to be the central nidus where both infectious and allergic processes originate.

What happened in the early 1970s? Antihistamines and decongestants became available over the counter and were heavily advertised on television. Medicaid and Medicare opened healthcare access to many more Americans. These drugs are designed and intended to block histamine-induced rhinorrhea and shrink swollen membranes. In effect, they turn off nasopharyngeal washing. Decongestants close the leaking blood vessels — turning off the water. Nasal steroids turn off the immune response to pollution in the nasopharynx.

For more than 25 years we systematically turned this normal defensive washing off, and experienced close to a three-fold increase in problems originating in this area. Eastern Bloc nations without Western television advertising or wholesale use of these drugs did not experience the asthma increases seen in the Western world. I documented this epidemiology in Medical Hypotheses (PMID 11535335).

Handwashing and the Nose Analogy

According to the Centers for Disease Control, handwashing is the most effective means of preventing the spread of communicable disease — because it protects the nose from the contamination associated with putting our hands to our faces. It makes as much sense to wash the nose regularly.

Using xylitol in a nasal spray is a very effective way of both assisting and stimulating the body's own natural nasopharyngeal washing, and reducing both bacterial colonization and allergenic pollution with their accompanying problems. Zabner and colleagues showed that a 5% xylitol solution sprayed four times daily decreased nasal coagulase-negative staphylococci after only four days (PMID 11005852). Xylitol lowers the salt concentration of airway surface liquid, allowing innate antibacterial properties to work more effectively.

What began as a grandmother's challenge and a teacher's observation about ear infections and learning became a clinical practice, a published case series, a patented delivery method, and eventually a product used by millions. For the full clinical reference with research citations and dosing guidance, see Medical Uses of Xylitol for Healthcare Professionals.