Balloon dilation of the eustachian tube is indeed a "gizmo" until future research proves safety and efficacy.

In the April 2014 issue of this journal, Richard M. Rosenfeld, MD, MPH, wrote an editorial in which he recommends distinguishing "fanciful gizmos from truly useful technology," provides 5 criteria to evaluate a gizmo, and includes as one of the current ones balloons to "open clogged ears." The implication is that balloon dilation for suspected eustachian tube dysfunction-middle ear disease is an unproven procedure. Coincidentally, on April 1, the National Institutes of Health (NIH) awarded an Exploratory/Development grant to the University of Pittsburgh to evaluate this new treatment, which affirms that the NIH agrees that this procedure is of uncertain efficacy.

Panel 2: Eustachian tube, middle ear, and mastoid--anatomy, physiology, pathophysiology, and pathogenesis.

OBJECTIVE: This report reviews the literature to identify the advances in our understanding of the middle ear (ME)-Eustachian tube (ET) system during the past 4 years and, on that basis, to determine whether the short-term goals elaborated in the last report were achieved and propose updated goals to guide future otitis media (OM) research. DATA SOURCES: Databases searched included PubMed, Web of Science (1945-present), Medline (1950 to present), Biosis Previews (1969-present), and the Zoological Record (1978 to present). The initial literature search covered the time interval from January 2007 to June 2011, with a supplementary search completed in February 2012. REVIEW METHODS: The panel topic was subdivided; each contributor performed a literature search and provided a preliminary report. Those reports were consolidated and discussed when the panel met on June 9, 2011. At that meeting, the progress was evaluated and new short-term goals proposed. CONCLUSIONS: Progress was made on 16 of the 19 short-term goals proposed in 2007. Significant advances were made in the characterization of ME gas exchange pathways, modeling ET function, and preliminary testing of treatments for ET dysfunction. IMPLICATIONS FOR PRACTICE: In the future, imaging technologies should be developed to noninvasively assess ME/ET structure and physiology with respect to their role in OM pathogenesis. The new data derived from form/function experiments should be integrated into the finite element models and used to develop specific hypotheses concerning OM pathogenesis and persistence. Finally, rigorous studies of treatments, medical or surgical, of ET dysfunction should be undertaken.

Consequences of evolution: is rhinosinusitis, like otitis media, a unique disease of humans?

We hypothesize that if otitis media is most likely primarily a human disease due to consequences of evolution, rhinosinusitis may also be limited to humans for similar reasons. If otitis media, with its associated hearing loss, occurred in animals in the wild, they probably would have been culled out by predation. Similarly, if rhinosinusitis occurred regularly in animals, they likely would have suffered from severely decreased olfactory abilities, crucial for predator avoidance, and presumably would likewise have been selected against evolutionarily. Thus, both otitis media and rhinosinusitis-common conditions particularly in infants and young children-appear to be essentially human conditions. Their manifestation in our species is likely due to our unique evolutionary trajectory and may be a consequence of adaptations, including adaptations to bipedalism and speech, loss of prognathism, and immunologic and environmental factors.

Persistent alternobaric vertigo at ground level.

We recently encountered a 15-year-old female with bilateral tympanostomy tubes who manifested persistent severe vertigo, at ground level, secondary to a unilateral middle-ear pressure of +200 mm H(2)O elicited by an obstructed tympanostomy tube in the presence of chronic nasal obstruction. We believe this is a previously unreported scenario in which closed-nose swallowing insufflated air into her middle ears, resulting in sustained positive middle-ear pressure in the ear with the obstructed tube. Swallowing, when the nose is obstructed, can result in abnormal negative or positive pressures in the middle ear, which has been termed the Toynbee phenomenon. In patients who have vertigo, the possibility that nasal obstruction and the Toynbee phenomenon are involved should be considered.

Human evolutionary history: consequences for the pathogenesis of otitis media.

The pathogenesis of otitis media is multifactorial, but the role of evolution on its development has not been addressed. We posit that the high prevalence of middle-ear disease is most likely restricted to humans, in contrast to other wild species, because the associated hearing loss would have reduced the fitness of affected individuals as a result of predation. We present here the possible consequences of two human adaptations that may have resulted in ubiquitous otitis media: the interaction of bipedalism and increased brain size, and the loss of facial prognathism resulting from speech or cooking. As a consequence of our adaptation for bipedalism, the female pelvic outlet is constricted, which, in the context of a rapidly enlarging brain, results in humans being born 12 months too soon. Significantly, immature eustachian tube structure and function, in conjunction with an immature immune system, helps to explain the high incidence of otitis media in the first year of life. But the persistence of middle-ear disease beyond this stage is not explained by "immaturity." The morphology of the palate changed with the adaptations that produced facial flattening, with concomitant effects on eustachian tube function. These changes resulted in relatively poor human physiologic tubal function in comparison to the nonhuman primate.

Adenoidectomy for otitis media with effusion in 2-3-year-old children.

OBJECTIVE: To compare the efficacy of three surgical treatment combinations - myringotomy and tympanostomy tube insertion (M&T), adenoidectomy with M&T (A-M&T), and adenoidectomy with myringotomy (A-M) - in reducing middle-ear disease in young children with chronic OME. METHODS: Children 24-47 months of age, with a history of bilateral middle-ear effusion (MEE) for at least 3 months, unilateral for 6 months or longer or unilateral for 3 months after extrusion of a tympanostomy tube, unresponsive to recent antibiotic, were randomly assigned to either M&T, A-M&T, or A-M. Treatment assignment was stratified by age (24-35 months, 36-47 months), nasal obstruction (no, yes) and previous history of M&T (no, yes). Subjects were followed monthly and with any signs or symptoms of ear disease for up to 36 months. RESULTS: Ninety-eight subjects were randomly assigned to the three treatment groups. Fifty-six subjects (57%) were 24-35 months of age; 63% had nasal obstruction, and 36% had previously undergone M&T. During the 36 months after entry, subjects were noted to have MEE for the following percentages of time: 18.6% in the M&T group, 20.6% in the A-M&T group, and 31.1% in the A-M group (M&T vs. A-M&T, p=0.87; M&T vs. A-M, p=0.01). By 36 months, there were no differences in the number of further surgical procedures for ear disease needed among the groups. CONCLUSIONS: Adenoidectomy with or without tube insertion provided no advantage to young children with chronic OME in regard to time with effusion compared to tube insertion alone. Fewer tympanostomy tubes were placed in children undergoing A-M as their initial procedure, but this should be balanced by the performance of the more invasive surgical procedure and their increased time with effusion.

Galapagos: Darwin, evolution, and ENT.

This year is especially important in the history of the theory of evolution; 2009 is the bicentennial anniversary of the birth of Charles Darwin and the sesquicentennial anniversary of his publication, The Origin of Species. Darwin visited the Galapagos Islands as a young man, which greatly influenced his thinking. My son Jim and I had the good fortune to visit these islands in January 2009 and see firsthand what led Darwin to arrive at his monumental insights into the origins of life on this planet. I have described my observations and related some of this experience to the ear, nose, and throat, albeit with whimsy in several instances. Nonetheless, some of the adaptations in the animals on these unique islands may have bearing on my hypotheses related to the incidence and pathogenesis of otitis media in humans. It is hoped the reader will share my enthusiasm for the experience we had on these fantastic islands and tour them in the future.

Impact of evolution on the eustachian tube.

I posit that humans appear to be the only species that develops otitis media. If animals in the wild had developed middle-ear disease to any significant degree, they would have been selected out during evolution because they would not have survived their predators given the associated hearing loss. Why do humans have otitis media? Evolution has had a significant impact. It is well known that humans are born 12 months too early, which is the result of adaptations to bipedalism and our big brain that, over time, resulted in a relatively small female pelvic outlet compared with nonhuman primates. As a consequence of too early a birth, not only is our immune system immature, but the eustachian tube is too short and floppy in the first year of life. But why is otitis media still common in older individuals? What other adaptation is uniquely human? We developed speech that was associated with descent of the larynx and hyoid bone, which, along with a decrease in prognathism (i.e., facial flattening), resulted in a change in palatal morphology as compared with other primates. Comparative anatomic and physiologic studies have demonstrated significant differences between humans and monkeys, especially in the muscles of the eustachian tube. Paradoxic constriction, as apposed to dilation, on swallowing is a common tubal dysfunction in humans and certain monkey models with chronic middle-ear effusion. My hypothesis is that chronic otitis media with effusion in patients with tubal constriction is a consequence of adaptation for speech and that, most likely, the levator veli palatini muscle is the cause.

Humans are born too soon: impact on pediatric otolaryngology.

Humans are born 12 months too early. Gestation should be 21 months. Humans evolved to become the pre-eminent animal in the world, but our big brain, bipedalism, and small female pelvic outlet have caused us to pay the price of being born too soon with all of its disadvantages. Early birth has an impact on diseases and disorders encountered by the otolaryngologist, including otitis media, laryngomalacia, tracheomalacia, congenital vocal cord paralysis, subglottic and tracheal stenosis, gastroesophageal reflux, congenital micrognathia, and congenital nasal alar collapse. Many of these conditions improve or resolve completely in the first year of life as an infant's immune system and anatomy matures. Knowledge of this evolutionary process can help us understand why some infants will grow out of certain diseases and disorders encountered in pediatric otolaryngology, while others will not.

Studies in otitis media: Children's Hospital of Pittsburgh-University of Pittsburgh progress report--2004.

OBJECTIVES/HYPOTHESIS: The present Progress Report has summarized the key otitis media clinical trials and laboratory studies conducted since 1969 by investigators at the Children's Hospital of Pittsburgh-University of Pittsburgh (Pittsburgh, PA). STUDY DESIGN: Review. METHODS: Included in the discussion are the following: 1) studies of the epidemiology and risk factors; 2) anatomy and pathology of the eustachian tube-middle ear from human temporal bone histopathological specimens; 3) physiology and pathophysiology of the eustachian tube-middle ear in humans and animal models; 4) pathogenesis; 5) otitis media in special populations (e.g., patients with cleft palate, Native Americans, patients with Down syndrome); 6) microbiology; 7) diagnosis; 8) outcomes of randomized clinical trials that evaluated efficacy of nonsurgical and surgical methods of treatment and prevention; 9) studies of certain complications and sequelae (e.g., effect of middle-ear effusion on hearing, early child development, and the vestibular system; chronic suppurative otitis media). Also included are relevant summary tables and 256 references.

The genetic component of middle ear disease in the first 5 years of life.

OBJECTIVE: To determine the genetic component of time with middle ear effusion (MEE) and episodes of MEE and acute otitis media. DESIGN: Prospective twin/triplet cohort. SETTING: Research center at a tertiary pediatric hospital. PARTICIPANTS: A total of 168 healthy same-sex twin and 7 same-sex triplet sets were recruited by age 2 months. INTERVENTIONS: Longitudinal assessment of middle ear status by pneumatic otoscopy and tympanometry at monthly evaluations, and at examinations during upper respiratory tract infections or symptoms of middle ear disease. OUTCOME MEASURES: Proportion of time with MEE and episodes of acute otitis media and MEE. RESULTS: Of the 140 sets for which zygosity was obtained, 114 were followed up to age 3 years and 83 sets to age 5 years. The heritability estimate for proportion of time with MEE in the first 5 years of life was 0.72 (P<.001). The correlation of proportion of time with MEE between children within a set was significantly higher in monozygotic sets (0.65-0.77) than in dizygotic sets (0.31-0.39) for each year to age 3 years. In the fourth and fifth years of life, the correlations decreased in both monozygotic and dizygotic twin sets. CONCLUSIONS: Findings for the first 2 years of follow-up have been previously published and indicate a strong genetic component to the proportion of time with MEE. In the present report, which details the entire 5-year follow-up, the effect of this component appears to attenuate after the third year but its cumulative effect remains significant after 5 years.

Eustachian tube function in older children and adults with persistent otitis media.

OBJECTIVE: Otitis media (OM) is most common in infants and young children. Despite a dramatic reduction in its incidence after the age of six, the disease still occurs in older children, adolescents, and may even persist into adulthood. The goal of this study was to identify characteristics of eustachian tube (ET) function in an older population which may underlie their persistent OM. METHODS: Following a medical history and a head and neck examination, 38 subjects over 6 years of age (64 ears) had their ET function assessed with the forced-response test (FRT). Parameters derived from this test included opening and closing pressures as well as steady-state and active resistances. RESULTS: Adenoidectomy had previously been performed in 71% of the sample. Clinically, 5% of these subjects had evidence of nasopharyngeal inflammation. The distributions of closing pressure and steady-state resistance were very similar to the distributions of the historic normal controls. The distributions of opening pressure and active resistance were highly skewed relative to the control sample. All study subjects had either abnormal opening pressures or high active resistance, with 79% having both abnormalities. CONCLUSIONS: If nasopharyngeal inflammation and hypertrophied adenoids are significantly correlated to ET dysfunction and persistent OM, this sample should be free of middle-ear (ME) disease. However, these individuals suffer persistent OM due to ET dysfunction characterized by high opening pressures and high active resistances. The abnormalities underlying these skewed forced-response parameters must be identified and corrected if we are going to alleviate the ME disease in these and similar patients.

Outcome of hearing and vertigo after surgery for congenital perilymphatic fistula in children.

PURPOSE: To determine if surgery to repair a perilymphatic fistula (PLF) has any significant morbidity and to determine the outcome of the surgery in regards to hearing and vertiginous symptoms. MATERIALS AND METHODS: A retrospective study was performed with all patients undergoing PLF repair at a tertiary medical center. Each patient was assessed for comparison of their pre- and postoperative hearing levels, vertiginous complaints, and recurrences. RESULTS: One hundred sixty ears were operated on for PLF over a 13-year period. Of the 103 ears positive for PLF, 92% either stabilized or improved their hearing and 3% noticed a decrease, but this was well after surgery and not believed to be related. These results were similar in the non-PLF ears in which 95% had stabilized or improved hearing and again 3% had a much delayed decrease. Of the children who had vertiginous complaints before surgery, 91% were improved or stable. Only 1 child felt somewhat worse, but, as in the hearing loss, this was greater than 6 months after the surgery. CONCLUSIONS: Surgical repair of PLF does not result in a significant risk for postoperative hearing loss or additional vertiginous complaints. Surgical repair may prevent further deterioration of hearing loss even in those patients in whom a PLF was not identified at the time of surgery.