Jack L. Paradise, M.D.
Let's suppose that your very healthy toddler has just gotten over an ear infection (medical term, acute otitis media) and is again acting normally. At his one-month post-illness check-up, your doctor tells you that the infection is now gone, but she adds that noninfective fluid is still present in his middle-ear cavity (medical term, otitis media with effusion). You ask whether the fluid is important. The doctor explains that fluid remaining for a month or so after an ear infection is common, and indeed expected, and is nothing to worry about provided that it doesn't last indefinitely. She warns you, however, that your child's hearing will be somewhat impaired so long as the fluid remains present.
At his next check-up a month later, you report that your child's hearing has seemed normal, but the doctor again finds fluid and this time confirms the finding with a test called a tympanogram. Nonetheless, she reassures you again and suggests that the fluid will likely be gone by the next check-up a month later. If not, she indicates that a consultation with an ear specialist might be in order.
Why is your doctor concerned?
Temporary Hearing Loss And Concerns About Children's Development
As the doctor indicated, middle-ear fluid is usually accompanied by some degree of hearing loss because the fluid dampens the transmission of sound waves. You can roughly approximate the degree of loss by listening while plugging your ear canals gently with your fingertips.
We know that language, speech, learning ability, and emotions in infants and toddlers are all developing at a rapid pace and that they are all subject to influences of various kinds, both internal and external. Under those circumstances, many doctors and other professionals concerned with children's development have worried that the reduced or distorted auditory input resulting from middle-ear fluid might, if continued over time, adversely affect one or another aspect of the children's development. These professionals worried further that infancy and early childhood might constitute "critical" or "sensitive" developmental periods, such that disturbances in development occurring during those periods might endure as "developmental scars," never to be completely cleared away.
Results of Studies And Impact On Practice
Underlying those professional concerns about children's development were many studies, carried out in various settings over some three decades. The studies seemed to show relationships between long periods of middle-ear fluid during children's first few years of life and various impairments of their speech, language, and learning skills and disturbances in their behavior at later ages, long after their middle-ear problems had ended and their hearing had returned to normal.
These concerns led to widespread professional endorsement of the practice of subjecting such children, after three or four months of continuous middle-ear fluid, to an operation termed myringotomy and tube insertion. This operation involves incision of the eardrum (myringotomy), removal of the fluid from the middle-ear cavity, and insertion of a tiny, plastic tube through the eardrum incision. The tube permits air to enter the middle ear, resulting in immediate restoration of normal hearing. Ventilation, necessary for the ear to remain healthy, is then maintained, along with normal hearing, for as long as the tube remains in place, usually about a year.
Given the concerns about developmental consequences of persistent middle-ear fluid, and given the demonstrated effectiveness of tube insertion, it is easy to understand why many professionals have advocated periodic screening of seemingly well children to detect the presence middle-ear fluid, and for those found to have fluid persisting for three months or longer, prompt surgical intervention. The situation, however, is by no means so straightforward.
Newer Study Results
First of all, close analysis shows that, as a group, the studies suggesting relationships between early-life otitis media and later developmental impairment had important flaws and limitations. To address the question more satisfactorily, in 1991 we began a study at the Children's Hospital of Pittsburgh that is still in progress. Supported mainly by the National Institute of Child Health and Human Development and the Agency for Healthcare Research and Quality, we enrolled over 6,000 healthy infants within the first two months of life and followed them closely. Those who developed persistent middle-ear fluid within their first three years of life were randomly assigned, with parental permission, to either receive ear tubes promptly or go into a watchful waiting group that would receive tubes only if their fluid persisted for an additional specified period.
Thus far, the study has shown no differences in measures of speech, language, learning ability or behavior at ages three years and four years between the children who had received ear tubes promptly and those in the watchful waiting group, most of whom escaped receiving tubes entirely. Results in the same children at age six years and age nine to eleven years are still pending.
Untoward Effects Of Tubes
A second issue is that tube placement is not consistently harmless. Common complications include blockage of the tube, extrusion of the tube from the eardrum prematurely, and secondary infection resulting in purulent discharge through the tube and into the ear canal. Later consequences, after the tube is out, include perforation of the eardrum and scarring that may leave the eardrum prone to develop certain serious conditions or may eventually result in some degree of hearing loss. Fortunately, these more serious outcomes are uncommon.
Finally, there is the cost of tube placement, currently about $3,000 overall.
New Recommendation: Watch And Wait
Taking note of the newer research findings, a committee comprising representatives from the American Academy of Family Physicians, the American Academy of Otolaryngology-Head Neck Surgery, and the American Academy of Pediatrics issued a revised Clinical Practice Guideline in 2004. The Guideline states that tube insertion performed solely to relieve persistent middle-ear fluid "does not improve developmental outcomes in infants and toddlers who are not at risk," and that children with persistent middle-ear fluid "who are not at risk should be reexamined at three- to six-month intervals until the effusion (fluid) is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected." In other words, for such children, don't just do something, sit there.
Qualifications
Importantly, the Pittsburgh study's findings cannot be generalized to children who are not otherwise healthy, or who have potentially handicapping conditions such as sensorineural hearing loss, cleft palate, or Down Syndrome. Neither can the findings be generalized to children with periods of middle-ear fluid longer than those we studied ‚ nine months if fluid was present in both ears, 13 1/2 months if in only one ear ‚ or, as indicated in the new Guideline, to the occasional child who has developed abnormalities of the eardrum or middle ear or whose fluid is consistently accompanied by moderately severe (rather than the usual mild to moderate) hearing loss. In that regard it is important that children with fluid lasting three months or longer receive careful audiometric testing to determine their actual degree of hearing loss, and periodic retesting so long as the fluid persists.
Tubes For Whom?
So which children should receive tubes? Mainly those who ‚ whether or not they have persistent middle-ear fluid ‚ have repeated bouts of ear infection that can't be managed satisfactorily with antibiotics or that recur with frequency that exceeds reasonable limits of tolerance. In such children, tubes usually provide welcome relief. Tube insertion is also the appropriate treatment for the child with persistent middle-ear fluid who is bothered by the associated hearing loss, whatever its degree; or who has an unusual related symptom, such as ear pain, ringing in the ear, or disturbance of balance; or whose eardrum has developed a potentially dangerous abnormality termed a retraction pocket.
In the relatively few children who have none of those conditions but in whom the duration of middle-ear fluid exceeds the limits we studied that were mentioned earlier, the point at which the operation should be considered remains debatable.
Factors arguing in favor of tube insertion include a child's questionable or suboptimal speech or language development for age in combination with substantial hearing loss, or an unfavorable history regarding the frequency and severity of ear infections.
Factors arguing against tube insertion would include good language skills, normal or near-normal hearing levels, limitation of the fluid to one ear, and a history relatively free of ear infection.
Importantly, because even persistent fluid usually clears spontaneously during the summer, watchful waiting through at least one summer season is advisable in all children with middle-ear fluid who are otherwise well.
Jack L. Paradise, M.D. is Professor of Pediatrics and Otolaryngology at the University of Pittsburgh School of Medicine and a pediatrician at Children's Hospital of Pittsburgh. Please send your questions and comments to him in care of Pediatrics for Parents, P.O. Box 63716, Philadelphia, PA 19147.
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