After the common cold, middle ear infection (otitis media, OM) is perhaps the most frequent of all childhood illnesses. When OM occurs as an isolated event in a normally healthy child it’s "no big deal". It’s not dangerous, is easily treated with antibiotics, and sometimes might even get better itself without treatment. Many young children, however, have persistent or repeated episodes of OM - either failing to respond to multiple courses of different antibiotics or having the problem recur very soon after stopping them.  An astounding one-half to two-thirds of all children will have frequent OM at some time in their lives!!!  This is a serious issue.  Much evidence suggests that such children may be at increased risk for hearing loss, speech problems, or even learning disabilities in the future.  The appropriate management of this situation is controversial, however.  Even among the best academic pediatricians and pediatric Otolaryngologists (ear-nose-throat specialists) there are many different approaches: medical vs. surgical, aggressive vs. conservative, conventional vs. experimental.  Because arguments for and against these various viewpoints are based largely on values, and because we don't yet have proven answers to many important questions about this subject, it is no wonder parents can be confused.  The purpose of this article is to clarify that confusion, while explaining what we consider to be a common sense, middle-of-the-road way of managing the recurrent or chronic middle ear disease in children.

THE BASICS:

The middle ear is a sinus - an air-filled space within the skull lined by mucous membrane (similar to inside the nose) and connected to the rest of the respiratory tree via a narrow opening or tube. Unlike other sinuses which are empty, the middle ear happens to contain structures vital to an important function; namely hearing. The middle ear also differs from other sinuses in that it can be directly examined with relative ease through the translucent window-like eardrum which separates it from the external ear canal. One final distinction is that the middle ear's connection to the respiratory tree, the eustacian tube (which runs from the middle ear to high in the throat behind the nose), is particularly long, narrow, and floppy - especially in infants and young children. This accounts for why this age group is so prone to OM.

Anything which causes congestion/swelling in the nose and throat (e.g. viruses, colds, sore throats, allergies, irritation from cigarette smoke or pollution, etc.) can and usually will cause the same thing to happen in the eustacian tube. Because the tube is so narrow, it often ends up completely blocked. It can also become blocked simply by mechanical forces (such as the pressure changes during a airplane ride) and in some people is so floppy it remains blocked much of the time just by collapsing on itself for no reason! Once blockage occurs for whatever reason, the air which is supposed to fill the middle ear starts to be replaced by fluid. This happens because blood vessels in mucous membranes constantly absorb air anyway, and if the eustacian tube is blocked this air can't be replaced. Soon a vacuum forms in the middle ear - pulling back the eardrum (transient and slightly painful) and causing fluid from the bloodstream to literally ooze out of those same vessels. Once fluid has completely filled the middle ear there is no more pain, but movements of the tiny bones which live in this sinus connecting the eardrum to nerve structures of the ear are damped - resulting in a reversible hearing impairment. The next thing which happens is germs (bacteria which normally lie dormant on the mucous membrane surface) see that all this fluid is good food for them. They come out of their dormant state, start to multiply, and overgrow wildly. Soon what started as clear fluid becomes thick yellow or green pus which is expanding, pushing the eardrum outward, and turning it bright red with inflammation. In the old days before antibiotics the next step would be spontaneous drainage - either by the pressure of this pus pushing open the blocked eustacian tube and draining into the throat; or by bursting through the thinned and irritated eardrum to the outside. In the latter case the resultant eardrum perforation would usually (but not always) heal up just fine on its own. In either case the problem would be over.

Nowadays things are not so simple.  Most children today are given an antibiotic before they reach the point of spontaneous drainage.  This usually has the effect of killing all the germs and sterilizing the middle ear fluid (providing the germs are sensitive to the antibiotic used), but it does ABSOLUTELY NOTHING to make the fluid go away or un-block the eustacian tube.  When a physician prescribes an antibiotic for OM, we simply are hoping and waiting for whatever process that blocked the tube to begin with to go away of its own accord.  Indeed, at the end of 10 days of antibiotics 33-50% of children treated for OM will still have fluid in the middle ear.  If those children are then left on antibiotics to prevent easy re-infection, that fluid will still be there after 30 days in 20%, after 60 days in 10%, and after 90 days in 5%!!!  While the fluid sits there it is causing 2 very separate problems.  One is that unless the child remains on antibiotics an infection is likely to recur or relapse.  The more important concern, however, is that as long as the fluid persists the child is not hearing normally.

THE PROBLEM:

Infants and toddlers are in a crucial phase of rapid language development.  Good hearing is thought to be essential for this process.  Indeed, there is ample data to demonstrate that persistent middle ear fluid leads directly to delays in speech development proportional to the total length of time fluid remains in the ears.  Data also shows that once the fluid goes away - either of its own accord or as a result of some medical or surgical treatment - hearing returns to normal virtually instantly and speech starts to quickly catch up!  For example, consider a 16 month old who has had fluid in his ears for 8 months, and who is speech delayed, only talking at a 10 month old level as a result.  He is 6 months behind.  If that child then outgrows his OM, he will start to catch up! B y 2 years he may be speaking at a 20 month level, only 4 months behind.  By 3 years such a child will probably no longer be delayed at all!

If this were the end of the story there would be no controversy, because the vast majority of children do outgrow the tendency toward OM (at ages that vary from 1 year to puberty, average being 2-4y) as their eustacian tubes grow wider and more bony.  Thus speech delays which result from OM could be viewed as fundamentally transient (and therefore harmless) phenomena.  Unfortunately, other evidence has established a statistical association between chronic OM and later learning disabilities (LD) or behavior problems.  While our knowledge is not yet detailed enough to establish a cause-effect relationship, many experts fear that while speech itself may "catch up", a child with OM "misses" other things that may never be recoverable and which may therefore directly cause learning disabilities (LD).  Other experts challenge this, suggesting that the two phenomenon (OM and LD) are both independent effects of a third root cause - a hypothesis which would explain the statistical association just as well.  Allergies, smoking parents, and socio-economic factors are the things most often mentioned as candidates for this "root cause", and indeed each of these things are also statistically associated with both OM and LD.  The simple fact is that until more research is done, we just don't know to what extent chronic OM causes learning disabilities. Until we answer that question we can't possibly know how "aggressive" we really ought to be in treating this problem.  Studies currently underway should begin to provide those answers by about 2008.

From a practical standpoint kids prone to OM can be separated into two groups: Recurrent OM (ROM, a.k.a. Frequent Acute Otitis) includes children who, despite many occurrences of fluid accumulation with or without infection, usually clear their middle ear fluid completely and for significant intervals between these episodes. These children have periods of hearing loss alternating with periods of normalcy.  They are therefore at low risk for long term harm.  Chronic OM (COM, a.k.a. Persistent Serous Otitis) includes children who never or hardly ever clear their middle ear fluid, regardless of how often they may get acute infections.  The COM group warrants more concern - they go long periods of time never hearing normally, and are thus at high risk for later disabilities.  A particular child may move from one group into another over time spontaneously or in response to treatment.

OUR APPROACH:

When you start to consider treatments beyond merely going from one 10-day course of antibiotics to the next for acute episodes, experts disagree over who to treat and what the goals of treatment should be. One approach is to say that only children with COM need be treated and anything which converts them from COM to ROM represents success.  Alternatively one could treat both COM and ROM and aim for a nearly OM-free state.  A middle ground would attempt to define an "acceptable OM frequency" within the ROM group.  This would of necessity be somewhat arbitrary, taking into account both the bias of the physician and the "tolerance" of individual parents.

Once one has decided upon treatment and defined one's therapeutic goals, a wide variety of possible approaches are available. Again there is no agreement in the medical community about which is best or even in what order they should be tried.  Many "medical" people (pediatricians) seem to advocate a mainly surgical approach; while many surgeons (ENT specialists) advocate a medical approach!  Some view surgery as excessively risky, while others view medicine as "just wasting time".

As you can see, the problem of "problem" ears is quite complex.  Physician's caring for children each need to "walk their own middle road" on all the above issues.  There are no simple answers and no one "right" approach. Which of the treatments described below are attempted and which are omitted, which come first and which come last are areas where practices vary widely.  Some pediatricians skip medical approaches altogether and refer immediately for PET's. Others "don't believe" in PET's under any circumstances, and stick solely to medical means.  Still others doctors consider medical approaches other than low-dose prophylaxis to be too infrequently successful to be worthwhile.  Some ENT specialists always take out the adenoids, some never do!

Our approach is to try ALL the options available, in approximately the order described above - like climbing the rungs of a ladder - until success is achieved.  Our guiding "philosophy' in developing this hierarchy is the belief that while chronic middle ear fluid and hearing loss is something which CANNOT be tolerated indefinitely ( or even for very long), surgery should be a last resort to which a child is subjected only when all else has failed.  In our experience the vast majority of children with COM (perhaps 80%) can be successfully managed without surgery.  Implicit in this approach, however, is a responsibility to follow such children closely and aggressively, ensuring that medical treatments are tried in a timely fashion and that those children who do need surgery are not subjected to undue delays.

2. LOW-DOSE ANTIBIOTIC PROPHYLAXIS: This strategy involves placing a child on long-term antibiotics at roughly half the dose usually used to treat an active infection (usually given once a day). It is started once the acute infection phase is over, when either uninfected fluid is left in the middle ear or the ear is fully clear. The purpose is to prevent reinfection of already present fluid (hopefully giving it time to go away) or of fluid which may reaccumulate should the eustacian tube block again. It is successful 80% of the time! First proposed by a urologist in the 1970's as a way of preventing recurrent urinary tract infections in adult women, this idea was at first subjected to intense criticism from medical specialists who raised all sorts of theoretical objections ranging from concerns about promoting resistant germs to worries about what effects long term antibiotics might have on various organ systems of the human body. Over the next decade research designed to show up these presumed flaws instead did a wonderful job of proving this strategy is both safe and effective in preventing infections in a whole host of "infection prone" clinical situations for both adults and children. It has now become a real mainstay of therapy for not only COM, but a variety of other pediatric conditions as well. It does not seem to matter which particular antibiotic is used, and the one small risk of developing an allergy to the antibiotic is easily dealt with by just switching to another antibiotic! The one important caution when using this approach is that the ears need to be carefully examined for the presence of fluid on a regular basis - perhaps once every 4-6 weeks. Because the child will no longer tend to get an infection when fluid accumulates and may therefore be without symptoms, regular examination is the only way to be sure the ears remain fluid-free a majority of the time so that "moving on to the next step" is unnecessary.

3. EXTENDED FULL-DOSE ANTIBIOTICS: In theory, once germs in the middle ear space are killed it should make no difference to the remaining fluid whether or not the child is on antibiotics, or at what dose. Despite this, however, certain children with refractory COM have been found to clear their middle ear fluid in response to longer-than-usual (30-45day) courses of full dose antibiotics - especially broad spectrum ones such as Augmentin, Suprax, or Ceclor. While as yet there are no published controlled studies documenting this phenomenon, the case reports suggesting such treatment works in some children are coming from well respected ENT departments such as the one at Children's Hospital in Boston.

4. SHORT COURSE "PULSE" STEROIDS: "Steroid" is a word which provokes much irrational thought, both among physicians and the lay public. This is unnecessary. The public tends to associate the word with anabolic steroids abused by some athletes - anabolic steroids have no legitimate medical use whatever and are not at all the same as the glucocortico-steroids used commonly by physicians to treat many ailments. The latter are potent anti-inflamatory agents which can be used either short or long term to control diseases characterized by inflammation such as asthma and arthritis. Older physicians tended to over-estimate the risks associated with glucocortico-steroids and therefore shy away from them. While it is true that long term therapy with such drugs involves many serious and unpleasant side effects, short term administration is associated with few risks and virtually no side effects whatever. It is, moreover, the quickest and most effective means available for controlling inflammation of virtually any sort. Over the past decade the appropriate role of short course steroids in the management of a wide variety of pediatric disorders - ranging from asthma to croup to meningitis - has received increasing emphasis in academic medical centers across the country. Against this backdrop, it has been reasonably suggested that short course steroids might be an effective way to reduce inflammation in and thereby unblock the eustacian tube. There have been 2 published studies of this hypothesis: One showed that children with COM given a short course of steroids at the outset of low dose antibiotic prophylactic therapy were significantly more likely to be fluid free 3 months later than a group started on antibiotic therapy alone. Another demonstrated that while an overwhelming majority (>90%) of children with COM given short course steroids cleared their middle ear fluid promptly, in about 80% of these kids the fluid reaccumulated within a short period of time. Still, in 20% a more extended fluid-free interval was gained, and that may well be a 20% shot worth taking. Success of a steroid pulse must be guaged not by initial clearing of fluid, but rather by how long the ears remain clear afterward. Because we can only give such treatment perhaps once every 3-4 months to avoid the side effects of long-term therapy, a "pulse" which "buys" 4 months of clear ears or more is deemed a success.

5. ANTIHISTAMINE/DECONGESTANTS: These common allergy and cold medications, available in many over-the-counter as well as prescription formulations, have the effect of both shrinking swollen mucous membranes and drying up fluid. As such they might be expected to help in COM. In actuality they are a two-edged sword which can "cut both ways" - while they will help open the eustacian tube and allow fluid to drain in some children, in others they will simply make the fluid thicker and the hearing loss worse. The common side effects of irritability, drowsiness, and blood pressure elevation they can cause must also be taken into account. As a practical matter using this kind of medication for COM I like to give a relatively high dose just once a day at bedtime when the side effects will matter less. Unlike options #3 or #4 above which are short term "shots" at eliminating the middle ear fluid which assume falling back to #2 if they work, this is a treatment which can be sustained over a long period of time if it seems to help. Because of the potential for it making matters worse however, I tend to save this as the "last trick up my medical sleeve". That way if it fails, the fluid thickens, and the hearing gets worse I know soon the child will be seeing a surgeon anyway and the fluid will be removed.

7. EAR TUBES: Formally called tympanostomy tubes or "pressure equalization" tubes (PET's), this procedure is one of the most frequently performed operations in this country today. It involves making an incision through the eardrum under general anesthesia, and inserting a small bobbin-shaped plastic tube through this opening to maintain a passageway from the middle to the outer ear. The purpose of this channel is simply to replace the malfunctioning eustacian tube. It is temporary, as the PET's will almost always fall out after an average time of about one year (range 2 days - 5 years, but most fall out between 6-18 months). When they do, you are "back to square one" - your child may have outgrown the propensity towards OM by then or may respond at that point to medical management or may again reach the point of needing repeat tubes. PET's are a very fast and simple operation with little short-term risk except for the anesthesia (which itself is much safer than it was just a few years ago), and is generally done as "day surgery" with no overnight stay. PET's are very effective at removing the middle ear fluid and almost instantly correcting any hearing loss that may have been present from the COM. While they don't prevent acute infections and may actually increase the risk of certain kinds of infection such as those precipitated by getting water in the ear, they do prevent the fluid from accumulating and persisting after such events. Children with PET's in place should wear ear plugs when swimming or otherwise immersing their heads in water. The major risks of PET's are really long term. Whenever you make a hole in the eardrum, there is a risk of that hole not closing (chronic perforation), closing with a scar that impairs eardrum movement resulting in permanent hearing loss, or having a scar that "overgrows" into a kind of benign tumor (cholesteatoma) which can press on and destroy other vital structures of the ear. The likelihood of such permanent complications increases with each subsequent set of tubes placed - with the first set it is perhaps 2% - with the second set it rises to 5-6% - with the third set 10-15% - some studies have estimated the risk of such complications in children who have had 4 or more sets of PET's as being as high as 40% !!! (Unfortunately these same studies have not looked at the question of learning disabilities in these same children - maybe that rate was quite low!)

8. ADENOIDECTOMY: The final and most aggressive surgical approach is removal of the adenoids. Adenoids are just like tonsils, but exist higher up in the throat behind the nose where you can't see them. Indeed, the adenoids are right beside the opening of the eustacian tubes, and when they enlarge may block that opening. Many studies have shown that adenoidectomy can end COM in a significant percentage of patients, especially those patients in whom the adenoids are enlarged. Some ENT surgeons these days like to do adenoidectomy in most or all patients they see even for a first set of PET's. More commonly this is reserved for the patient getting a repeat set of PET's, however, in hopes of preventing any more repeats. Often a tonsilectomy will be done at the same time, especially if there is any history of mouth breathing or frequent sore throat. Unlike PET's alone, tonsilectomy and adenoidectomy (T&A) are NOT "minor" surgery - the procedure is lengthy, involves a lot of cutting and a significant risk of bleeding. Although insurance companies nowadays insist that we at least try to do this as "day surgery", no good pediatric ENT surgeon I know is really comfortable with this idea, and neither am I. Therefore a one or two night hospital stay is often needed, albeit rarely "officially planned" in advance. On the other hand, T&A carries no real long-term risks whatsoever.