Middle Ear Infections

by Food and Drug Administration (FDA)

Eavesdrop among parents at any playground and you'll hear them swapping tales about one of the most common maladies of toddlerhood — ear infections. The sleepless nights, endless trips to the pediatrician, and repeated rounds of expensive antibiotics are so common they're something of a preschool rite of passage. Ninety percent of American children will have had at least one ear infection before age 6.

Collectively called otitis media (inflammation of the middle ear), ear infections and middle ear fluid accounted for 24.5 million doctors' visits in 1990, a 150 percent increase since 1975, according to the national Centers for Disease Control and Prevention. Americans spend $3.5 billion each year to treat them.

Physicians have traditionally taken an aggressive approach to fight various types of otitis media, maintaining that a young child's hearing needs to be at its best during language development.

Yet recently, doctors and researchers have begun to debate traditional approaches to treating otitis media, especially otitis media with effusion (OME), which is chronic and can cause mild hearing loss. Although FDA doesn't have authority over how doctors treat ear infections, the agency does regulate all drugs and devices used in the process and is interested in the outcome of recent OME research.

OME occurs when the middle ear doesn't drain properly and fills with a sticky fluid, but causes no symptoms of infection such as pain or fever. Sometimes called "glue ear," OME often appears after a cold or acute ear infection. Children are more prone to the condition than adults because their eustachian tubes, which drain fluid from the ear to the nose, are short and horizontal and often don't function properly.

An acute ear infection, called acute otitis media (AOM), is caused by bacteria or viruses. This condition is very painful and makes a child feverish and fretful (often in the middle of the night).

While most American doctors agree about how to treat acute otitis media, much debate has risen recently in the United States about the best remedy for otitis media with effusion.

Ironically perhaps, the latest consensus among researchers reveals that the best treatment is an easy one — "watch and wait."

A Frustrating Earful

As parents and doctors can attest, getting rid of middle ear fluid is tricky. Antibiotics don't always work, while surgical remedies are costly, often frightening, and may not solve the problem once and for all.

Last July, the Agency for Health Care Policy and Research (AHCPR), a component of the Public Health Service, issued new guidelines for treating otitis media with effusion.

A panel of independent experts recommended changing the traditional approach for treating OME in children ages 1 to 3, which has involved initially prescribing antibiotics. If that didn't clear it up, doctors inserted tympanostomy tubes, small tubes in the eardrum to drain the fluid behind it.

The panel found, however, that rushing into either treatment is not necessary. Middle ear fluid goes away on its own within three months in about 60 percent of cases and within six months in 85 percent of cases.

The panel recommended that when a child has ear fluid and no signs of infection, physicians should take a "watch and wait" attitude for three months. After that, if the fluid is still present, the child's hearing should be tested. If hearing is normal, the doctor should either continue watchful waiting or begin antibiotic treatment.

In the event of hearing loss, however, the physician should begin antibiotic treatment or try tympanostomy tubes. FDA has approved a number of tubes for the procedure. The panel recommends them only if the OME lasts four to six months and there's hearing loss in both ears.

Procedures such as taking out the child's adenoids or tonsils, or administering steroids, decongestants and antihistamines, are ineffective and should not be done, the panel said.

"If all doctors followed these guidelines, there would be fewer antibiotics prescribed and fewer surgeries as well," says Alfred Berg, M.D., co-chairman of the panel and professor of family medicine at the University of Washington School of Medicine in Seattle.

Although the panel limited its recommendations to OME, some researchers have begun to question the way American doctors use antibiotics for acute otitis media as well. AOM is treated with a 7- to 10-day round of antibiotics in more than 90 percent of cases. For children with recurrent infections, physicians sometimes prescribe a daily low dose of antibiotics for weeks as a preventative measure. While this approach can be effective, it may also encourage resistant strains of bacteria to develop. Physicians aware of this possibility can adjust medications if necessary.

"Treatment of acute otitis media is basically by tradition, a tradition that has not been adequately investigated," says Larry Culpepper, M.D., a professor of family medicine at Brown University and member of the AHCPR panel.

"I think the real answer is that we don't know for sure if there's a significant benefit for treating kids with antibiotics [for acute otitis media]," he says.

European doctors don't treat AOM the way American doctors do, Culpepper says. Overseas, doctors commonly take a "watch and wait" attitude. When they do order antibiotics, it's for a shorter period and at lower doses.

Culpepper is conducting a study comparing treatment of AOM in the Netherlands, the United Kingdom, and the United States. By examining the results of treating 4,500 children, he hopes to see which country's approach produces the best results.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.