Resolution of Otitis Media With Effusion in Children With Cleft Palate Followed Through Five Years of Age.

OBJECTIVE: To describe the temporal pattern of otitis media with effusion (OME) resolution for a cohort of nonsyndromic cleft palate children enrolled before palatoplasty and followed through 5 years of age. DESIGN: This is a prospective, longitudinal study of the time course for OME resolution in infants and children with palatal clefts. SETTING: Cleft Palate Craniofacial Center of a tertiary care pediatric hospital. PARTICIPANTS: This study included 52 children with cleft palate (29 boys, 45 white, Veau 1 through 4) who had a Furlow-type palatoplasty between 10 and 24 months of age performed by one of six surgeons. INTERVENTIONS: Standard cleft palate management was supplemented with study visits to the research clinic pre- and postpalatoplasty and then yearly to 6 years of age for assessments of middle ear status by interval history, otoscopy, and tympanometry. MAIN OUTCOME MEASURE: The main outcome measure was age at otitis media resolution defined as the age in years at the first in a sequence of "disease-free" diagnoses not interrupted or followed by any other diagnosis. RESULTS: The cumulative percent OME resolution for ears/children at ages <1, 1, 2, 3, 4, 5 years was 4.1/4.4, 14.3/10.9, 31.6/21.7, 45.9/37.0, 56.1/50.0, and 70.4/60.9%. OME resolution followed a simple linear time curve with slopes of 13.5% (confidence interval [CI] = 12.2% to 14.8%, r(2) = .99) and 11.9% (CI = 10.1% to 13.6%, r(2) = .99) resolutions per year for ears and children, respectively. CONCLUSIONS: There is a natural, age-related pattern of resolution for persistent OME that affects most infants and young children with cleft palate that is not affected by palatoplasty.

Dissecting eustachian tube dysfunction: From phenotypes to endotypes.

OBJECTIVE: A broad spectrum of complaints, symptoms and manifestations has been assigned to Eustachian tube (ET) dysfunction (ETD). While such presentations may manifest as ETD phenotypes, underlying mechanisms are defined as endotypes. Our goal is to develop a diagnostic approach to differentiate the endotypes and guide clinicians in the workup and selection of treatments targeting the mechanism of ETD. STUDY DESIGN: Retrospective. SETTING: Tertiary care. SUBJECTS AND METHODS: Children and adults with suspected ETD were evaluated with a thorough examination, otomicroscopy, otoendoscopy, trans-nasal videoendoscopy and testing of passive and active ET dilatory properties. Degree of weakness in soft palate elevation and ET orifice widening (muscular weakness, ETD-M), presence of inflammation (ETD-I) and/or adenoid tissue impinging and restricting the ET opening (ETD-R) were assessed with video-endoscopy. The Forced Response Test, Inflation-Deflation Test and Pressure Chamber Test were used as applicable to quantify the degree and type of difficulty (Stricture, ETD-S or adhesive, ETD-A) or ease (patulous or semi-patulous, ETD-P/SP) in opening the ET, and degree of active muscular strength/weakness (ETD-M) was measured. Ears with normal function (ETF-N) findings were also identified. RESULTS: Video-endoscopic and ETF test results were obtained for 71 ears of 40 subjects (22 males, 18 females; 38 white, 2 black), with an average age of 22.9 ± 16.5 years (min:6.2, max:64.1). Videoendoscopy (21, 13, 33, 16, 13, 0, 0 ETs) and ETF testing analysis (20, 24, 0, 38, 0, 3, 13 ears) were categorized as ETF-N and the ETD endotypes ETD-S, ETD-R, ETD-M, ETD-I, ETD-A, and ETD-P/SP, respectively. Some phenotypes had features consistent with more than one endotype. CONCLUSION: A systematic approach of examination and testing may differentiate the specific underlying mechanisms, lead to a treatment targeted to the ETD endotype and may establish novel ways to diagnose and treat ETD.

Treatment of acute otitis media in young children.

Although acute otitis media (AOM) is one of the most common pediatric problems, the debate over treatment, especially in young children, continues. The 2004 Guideline on treatment of AOM stated that observation without antimicrobial therapy was an option for selected children 6-24 months of age with AOM. Two recent randomized trials sought to determine the necessity of antimicrobial treatment in young children; both studies found modest, statistically significant, positive effects of treatment. However, these studies provoked a flurry of discussion in the literature and the issue remains unsettled. That prevention is preferable to treatment is not controversial. Eliminating or modifying risk factors and use of vaccines, both bacterial and viral, may help decrease the number of AOM episodes. The discussion on treatment of AOM in young children must also take into account side effects of treatment and effect of treatment on possible long-lasting sequelae of AOM, such as developmental outcomes.

Postpalatoplasty Eustachian tube function in young children with cleft palate.

OBJECTIVE: To characterize Eustachian tube function using the forced response test in young children with cleft palate with or without cleft lip after palatoplasty with tympanostomy tubes inserted prepalatoplasty and compare these results with those of a 1986 study that evaluated a similar population using identical methods. SETTING: Outpatient research clinic. PATIENTS/PARTICIPANTS: A total of 34 children with cleft palate were tested at an average age of 18.6 ± 4.0 months. MAIN OUTCOME MEASUREs: Passive and active measures for the forced response test. RESULTS: Of the sample, 13 ears could not be tested, and tests on 24 ears were incomplete. The forced response test showed that the passive Eustachian tube function parameters were similar to those of normal adults and children. The percentage of ears that showed tubal dilation with swallowing was 60%. The active resistance and dilatory efficiency were similar to those of a normal adult population. CONCLUSIONS: A 1986 study of Eustachian tube function in postpalatoplasty subjects with cleft palate (37 ears) aged 15 to 26 months documented Eustachian tube dilation with swallowing in 84% of the ears. In the present study, which focused on a similar population, the frequency of tubal dilation was 60%. Nonetheless, both frequencies are significantly greater than the dilation frequency of 27% reported for 56 ears of subjects with cleft palate tested between 3 months and 18 years with tympanostomy tubes inserted for persistent otitis media with effusion. This suggests that dilation during the forced response test may be a prognostic marker for those children with cleft palate who will resolve their ear disease at an early age.

Eustachian tube function in adults without middle ear disease.

OBJECTIVES: We sought to develop normative values for 5 eustachian tube function (ETF) test protocols in adults without otitis media (OM). METHODS: Twenty adults (19 to 48 years of age) without a recent history of OM (5 had OM in childhood) underwent unilateral myringotomy and were evaluated for ETF by use of the forced response, inflation, deflation, forcible "sniff", and Valsalva test protocols. When possible, these tests were repeated on a second day. RESULTS: Normative values for the parameters of these protocols in adult subjects without a recent history of OM were developed. Between-day data for the forced response test were highly correlated. A percentage of these tests showed eustachian tube "constriction" during swallowing--an abnormal condition. The percent reduction in applied pressures for the inflation and deflation tests was high, indicative of good ETF. Few subjects had a positive "sniff" test, whereas most had a positive Valsalva test, and the results for both tests were effort-dependent. CONCLUSIONS: Results of ETF tests in adults with and without recent OM have not been published. Normative data are now available for comparison with ETF test results in adults with OM. These protocols will be used to evaluate the efficacy of surgical procedures designed to improve ETF.

Otitis media: a genome-wide linkage scan with evidence of susceptibility loci within the 17q12 and 10q22.3 regions.

BACKGROUND: Otitis media (OM) is a common worldwide pediatric health care problem that is known to be influenced by genetics. The objective of our study was to use linkage analysis to map possible OM susceptibility genes. METHODS: Using a stringent diagnostic model in which only those who underwent tympanostomy tube insertion at least once for recurrent/persistent OM are considered affected, we have carried out a genome-wide linkage scan using the 10K Affymetrix SNP panel. We genotyped 403 Caucasian families containing 1,431 genotyped individuals and 377 genotyped affected sib pairs, and 26 African American families containing 75 genotyped individuals and 27 genotyped affected sib pairs. After careful quality control, non-parametric linkage analysis was carried out using 8,802 SNPs. RESULTS: In the Caucasian-only data set, our most significant linkage peak is on chromosome 17q12 at rs226088 with a p-value of 0.00007. Other peaks of potential interest are on 10q22.3 (0.00181 at rs1878001), 7q33 (0.00105 at rs958408), 6p25.1 (0.00261 at rs554653), and 4p15.2 (0.00301 at rs2133507). In the combined Caucasian and African American dataset, the 10q22.3 peak becomes more significant, with a minimal p-value of 0.00026 at rs719871. Family-based association testing reveals signals near previously implicated genes: 513 kb from SFTPA2 (10q22.3), 48 kb from IFNG (12q14), and 870 kb from TNF (6p21.3). CONCLUSION: Our scan does not provide evidence for linkage in the previously reported regions of 10q26.3 and 19q13.43. Our best-supported linkage regions may contain susceptibility genes that influence the risk for recurrent/persistent OM. Plausible candidates in 17q12 include AP2B1, CCL5, and a cluster of other CCL genes, and in 10q22.3, SFTPA2.

The incidence, prevalence and burden of OM in unselected children aged 1-8 years followed by weekly otoscopy through the "common cold" season.

BACKGROUND: There is a continuing interest in defining the incidence, prevalence and burden of otitis media (OM) in the individual and population for purposes of assigning "risk factors". Often overlooked in past studies are the contributions of cold-like illnesses (CLIs) and sampling interval to those estimates. OBJECTIVE: Describe the incidence of symptomatic (AOM) and asymptomatic (OME) OM, the prevalence of OM, the contribution of CLI incidence, burden and other OM "risk factors" to the incidence and burden of OM, and the effect of sampling interval on those measures in children. METHODS: 148 children (74 male; 131 white, aged 1.0-8.6 years) were followed from November 1 to April 30 by weekly pneumatic otoscopy to diagnose OM presence/absence and by daily parental diary to assign CLI episodes. Data for previously identified OM "risk factors" were collected on 127. Results were summarized using standard measures of incidence, prevalence and burden, and multiple regression techniques were used to identify OM "risk factors". RESULTS: The basal OM prevalence was 20% with peaks in December and March and the temporal pattern was correlated with CLI prevalence. The incidence of OME (per 27,232 child-days) was 317, AOM was 74 and CLI was 456. The seasonal pattern of AOM and OME incidences tracked and was correlated with that for CLIs. New OM episodes were usually of short duration (

Balance and otitis media with effusion.

Dizziness can be caused by a variety of peripheral vestibular, central, and systemic disease processes. Eustachian tube dysfunction with and without middle-ear effusion has been considered one of the most common causes of balance disturbances in young children. Several studies have indicated that during an episode of otitis media the child's balance deteriorates and the child may become clumsy and fall more often. Thus, not only the adverse effect on hearing should be considered in the management of a child with otitis media, but also the child's balance.

Temporal relationships for cold-like illnesses and otitis media in sibling pairs.

BACKGROUND: New otitis media (OM) episodes are most frequently a complication of cold-like illnesses (CLIs) which are often virus infections that can be exchanged within the family unit. Interference with intrafamily CLI transmission may present a strategy for OM prophylaxis in high risk children. This study estimated factors relevant to strategy efficiency. METHODS: Two siblings (ages, 1.0-4.3 and 1.7-6.1 years) from 69 families were followed for 193 days beginning in October using daily parental diaries focused on CLI signs and weekly pneumatic otoscopy to diagnose OM presence/absence. An algorithm converted the signs to presence/absence of a cold-day; cold-days were grouped into CLI episodes, and episodes were examined for intersib transmission and OM complications. RESULTS: We identified 267 CLIs in the younger siblings and 221 in the older siblings. Twenty-seven percent of the CLI episodes in one sibling occurred after CLI onset in the other with a median interval of 3 days. Sixty-two percent of newly diagnosed OM episodes occurred during a CLI and 27% of CLIs were complicated by OM. Analysis of factors that could affect CLI incidence documented significant contributions of gender, age, daily environment and the CLI burden in the sibling with expected directionalities. CONCLUSION: The results document intrafamily transmission of CLIs that is often associated with the development of OM as a complication. These observations and the measured interval between primary and secondary CLI onsets support the possibility of preventing OM by strategies that target intrafamily CLI transmission.

Contribution of vision to balance in children four to eight years of age.

OBJECTIVES: The use of sensory feedback for postural control develops throughout childhood. The aim of this study was to determine how children use cues from anterior-posterior optic flow for balance from 4 to 8 years of age. METHODS: One hundred forty-eight children were enrolled. The subjects had yearly otologic and posturographic examinations between the ages of 4 and 8 years. Balance was assessed only if the subject had no evidence of middle ear effusion. The subject stood for 30 seconds with eyes open without optic flow and for 30 seconds while viewing 0.1, 0.25, and 0.4 Hz anterior-posterior optic flow. The center of pressure (COP) was recorded from the force platform. The root-mean-square of the COP during the periods of quiet stance and with optic flow was computed. RESULTS: The root-mean-square COP was significantly larger during the optic flow stimulation as compared with during quiet stance. The subjects had a significant decrease in COP during optic flow from year 5 to year 6 of life (p = .005). CONCLUSIONS: A change in the response to optic flow was seen from age 5 to age 6. This change is consistent with transitional changes in postural responses that have been observed during quiet standing.

Panel 7: Otitis Media: Treatment and Complications.

Objective We aimed to summarize key articles published between 2011 and 2015 on the treatment of (recurrent) acute otitis media, otitis media with effusion, tympanostomy tube otorrhea, chronic suppurative otitis media and complications of otitis media, and their implications for clinical practice. Data Sources PubMed, Ovid Medline, the Cochrane Library, and Clinical Evidence (BMJ Publishing). Review Methods All types of articles related to otitis media treatment and complications between June 2011 and March 2015 were identified. A total of 1122 potential related articles were reviewed by the panel members; 118 relevant articles were ultimately included in this summary. Conclusions Recent literature and guidelines emphasize accurate diagnosis of acute otitis media and optimal management of ear pain. Watchful waiting is optional in mild to moderate acute otitis media; antibiotics do shorten symptoms and duration of middle ear effusion. The additive benefit of adenoidectomy to tympanostomy tubes in recurrent acute otitis media and otitis media with effusion is controversial and age dependent. Topical antibiotic is the treatment of choice in acute tube otorrhea. Symptomatic hearing loss due to persistent otitis media with effusion is best treated with tympanostomy tubes. Novel molecular and biomaterial treatments as adjuvants to surgical closure of eardrum perforations seem promising. There is insufficient evidence to support the use of complementary and alternative treatments. Implications for Practice Emphasis on accurate diagnosis of otitis media, in its various forms, is important to reduce overdiagnosis, overtreatment, and antibiotic resistance. Children at risk for otitis media and its complications deserve special attention.

Recent developments in the treatment of otitis media with effusion.

The management of otitis media with effusion (OME) has received much attention recently as a result of, among other factors, the development of resistant bacteria and the finding of less long-term impact of middle-ear effusion (MEE) on development than previously believed. Guidelines have recently been published for the management of OME promoting more accurate diagnosis, particularly distinguishing acute otitis media from OME, and recommending the 'judicious' use of antibacterials. Today, more emphasis is being placed on prevention of disease by reducing risk factors and the development of vaccines. The identification of susceptibility genes may lead to better understanding of the pathogenesis of otitis media, which in turn may lead to the development of more innovative and satisfactory methods for prevention and treatment.

Information on co-morbidities collected by history is useful for assigning Otitis Media risk to children.

OBJECTIVES: Determine if a 2-Step multivariate analysis of historical symptom/sign data for comorbid diseases can abstract high-level constructs useful in assigning a child's "risk" for different Otitis Media expressions. METHODS: Seventeen items related to the symptom/sign expression of hypothesized Otitis Media comorbidities were collected by history on 141 3-year-old children. Using established criteria, the children were assigned to 1 of 3 groups: Control (no significant past Otitis Media, n=45), Chronic Otitis Media with Effusion (n=45) and Recurrent Acute Otitis Media (n=51). Principal Component Analysis was used to identify factors representing the non-redundant shared information among related items and Discriminant Analysis operating on those factors was used to estimate the best predictor equation for pairwise group assignments. RESULTS: Six multivariate factors representing the assignable comorbidities of frequent colds, nasal allergy, gastroesophageal disease (specific and general), nasal congestion and asthma were identified and explained 81% of the variance in the 17 items. Discriminant Analysis showed that, for the Control-Chronic Otitis Media with Effusion comparison, a combination of 3 factors and, for the Control-Recurrent Acute Otitis Media comparison, a combination of 2 factors had assignment accuracies of 74% and 68%, respectively. For the contrast between the two disease expressions, a 2-factor combination had an assignment accuracy of 61%. CONCLUSION: These results show that this analytic methodology can abstract high-level constructs, comorbidities, from low-level data, symptom/sign scores, support a linkage between certain comorbidities and Otitis Media risk and suggest that specific comorbidity combinations contain information relevant to assigning the risk for different Otitis Media expressions.

Eustachian Tube Function in 6-Year-Old Children with and without a History of Middle Ear Disease.

OBJECTIVE: To test the hypothesis that eustachian tube opening efficiency, measured as the fractional gradient equilibrated (FGE), is lower in 6-year-old children with no middle ear disease but a well-documented history of recurrent acute otitis media, as compared with children with a negative disease history (control). STUDY DESIGN: Cross-sectional study. SETTING: Tertiary care pediatric hospital. SUBJECTS AND METHODS: Bilateral eustachian tube function was evaluated in 44 healthy 6-year-old children (19 boys, 29 white). None had middle ear disease at the time of testing, but 23 had a history of recurrent acute otitis media. Twenty-one had no significant past otitis media. Eustachian tube function was measured with a pressure chamber protocol that established negative middle ear gauge pressures (referenced to the chamber pressure) and recorded that pressure before and after a swallow. FGE was calculated as the change in middle ear gauge pressure with swallowing divided by the preswallow pressure. Between-group comparisons of the preswallow pressures and FGEs were made with a 2-tailed Student's t test. RESULTS: FGE was independent of the preswallow middle ear gauge pressure. For the 39 and 44 evaluable ears in the control and recurrent acute otitis media groups, the mean preswallow pressures were -194 daPa (95% confidence interval [95% CI] = -211 to -177) versus -203 (95% CI = -216 to -190; P > .40), and FGEs were 0.32 (95% CI = 0.21-0.43) vs 0.16 (95% CI = 0.08-0.24; P = .016), respectively. CONCLUSION: In children with past recurrent acute otitis media, residual eustachian tube opening inefficiency is maintained after they have "outgrown" their middle ear disease.

Genetic susceptibility to otitis media.

PURPOSE OF REVIEW: Otitis media is a disease that is prevalent in the pediatric population, and recent twin and triplet studies have confirmed that there is a strong genetic component to susceptibility. Here, we summarize the status of current efforts to identify the specific genes underlying otitis media susceptibility and presentation. RECENT FINDINGS: Recent studies have focused on identifying candidate genes. For example, IFN-gamma polymorphisms, allotypes of the leukocyte IgG (FcgammaR) receptors and certain haplotypes of surfactant genes were linked in pilot studies to otitis media susceptibility. The pattern of gene expression during an episode of otitis media is also being elucidated with the overall goal of providing clues as to which of these modulated genes are polymorphic and thus potentially capable of affecting otitis media susceptibility. Mucin and cathepsin protease genes were shown to exhibit these characteristics. SUMMARY: In addition to the simple searches for linkages between known genes and otitis media, work is progressing within the context of genome-wide linkage studies. These efforts promise to answer some of the many questions remaining in otitis media susceptibility and pathogenesis.

Water precautions and tympanostomy tubes: a randomized, controlled trial.

OBJECTIVES/HYPOTHESIS: The objective was to determine whether there is an increased incidence of otorrhea in young children with tympanostomy tubes who swim and bathe without water precautions as compared with children who use water precautions in the form of ear plugs. STUDY DESIGN: Prospective, randomized, investigator-blinded, controlled trial. METHODS: Two hundred one children (age range, 6 mo-6 y) who had undergone bilateral myringotomy and tube insertion were randomly assigned into one of two groups: swimming and bathing with or without ear plugs. Children were seen monthly for 1 year and whenever there was intercurrent otorrhea. RESULTS: Ninety children with and 82 children without ear plugs returned for at least one follow-up visit. Mean (SD) duration of follow-up was 9.4 (4.1) months for the children with ear plugs and 9.1 (4.4) months for the children without ear plugs. Forty-two children (47%) who wore ear plugs developed at least one episode of otorrhea, as compared with 46 (56%) who did not use ear plugs (logistic regression adjusting for stratification variables, P = .21). The mean (SD) rate of otorrhea per month was 0.07 (0.31) for the children who wore ear plugs as compared with 0.10 (0.31) for the children who did not wear ear plugs (Poisson regression adjusting for stratification variables, P = .05). CONCLUSION: There is a small but statistically significant increase in the rate of otorrhea in young children who swim and bathe without the use of ear plugs as compared with children who use ear plugs. Because the clinical impact of using ear plugs is small, their routine use may be unnecessary.

Predisposition to Childhood Otitis Media and Genetic Polymorphisms within the Toll-Like Receptor 4 (TLR4) Locus.

BACKGROUND: Predisposition to childhood otitis media (OM) has a strong genetic component, with polymorphisms in innate immunity genes suspected to contribute to risk. Studies on several genes have been conducted, but most associations have failed to replicate in independent cohorts. METHODS: We investigated 53 gene polymorphisms in a Finnish cohort of 624 cases and 778 controls. A positive association signal was followed up in a tagging approach and tested in an independent Finnish cohort of 205 cases, in a British cohort of 1269 trios, as well as in two cohorts from the United States (US); one with 403 families and the other with 100 cases and 104 controls. RESULTS: In the initial Finnish cohort, the SNP rs5030717 in the TLR4 gene region showed significant association (OR 1.33, P = .003) to OM. Tagging SNP analysis of the gene found rs1329060 (OR 1.33, P = .002) and rs1329057 (OR 1.29, P = .003) also to be associated. In the more severe phenotype the association was stronger. This finding was supported by an independent Finnish case cohort, but the associations failed to replicate in the British and US cohorts. In studies on TLR4 signaling in 20 study subjects, the three-marker risk haplotype correlated with a decreased TNFα secretion in myeloid dendritic cells. CONCLUSIONS: The TLR4 gene locus, regulating the innate immune response, influences the genetic predisposition to childhood OM in a subpopulation of patients. Environmental factors likely modulate the genetic components contributing to the risk of OM.

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.

Aural irrigation using the OtoClear Safe Irrigation System in children.

OBJECTIVE: To evaluate the safety and efficacy of the OtoClear Safe Irrigation System for removing cerumen from the external auditory canal in children. METHODS: Eligible subjects were 6 months-17 years of age with cerumen obstructing > or = 50% of the tympanic membrane (TM) from view (by otoscopy). Pneumatic otoscopy, tympanometry, and audiometry were performed followed by cleansing of the affected ear canal(s) with the OtoClear Safe Irrigation System and warm tap water. Otoscopy was performed after each wash of the canal. A curette or small alligator forceps was used to remove remaining cerumen if necessary. Tympanometry and audiometry were repeated after all procedures were completed. Telephone contact was made 1 week later regarding symptoms of acute otitis externa or any other problems. RESULTS: Eighteen children (28 ears) ages 1-10/12 to 11-2/12 years were entered. Four had previously had tympanostomy tubes. At entry, there was no visible TM in 19 ears, 5-10% visible TM in 5 ears, 20% in 1 ear, and 30-40% of the TM in 3 ears. The number of washes needed per ear was: 1 wash--16 ears, 2 washes--8 ears, 3 washes--1 ear, 4 washes--2 ears; washing was stopped in 1 ear because of pain. After irrigation, a curette or forceps was used in 6 ears. Following the procedures, > or = 95% of the TM was visible in 24 ears, and > or = 80% was visible in all ears. Six ears (4 children) with flat tympanograms at entry became normal after irrigation. On audiometry, a conductive loss in 2 ears at entry resolved after irrigation. The mean change in pure tone average (PTA) was -2.9 dB. Three subjects were noted to have hearing losses >5 dB at some frequencies which on review by audiologists were deemed non-significant. No perforations of the TM occurred. There were no reports of otitis externa or any other adverse events occurring after leaving the clinic. CONCLUSION: We found the OtoClear Safe Irrigation System to be safe and effective in our small sample of children. It was well tolerated in most and provided a non-traumatic method for the removal of obstructing cerumen.

The forced-response test does not discriminate ears with different otitis media expressions.

OBJECTIVES/HYPOTHESIS: Test the hypothesis that the eustachian tube (ET) function measured using standard manometric test methods is different between groups of ears with tympanostomy tubes inserted for recurrent acute otitis media (RAOM) and for chronic otitis media with effusion (COME). STUDY DESIGN: A cross-sectional study of ET function in populations of young children with different otitis media expressions. METHODS: The results for forced-response testing of ET function were compared using a general linear model between 37 ears of 26 children and 34 ears of 26 children, aged 3 and 4 years, with ventilation tubes inserted for COME and RAOM, respectively. RESULTS: There were no significant between-group differences in either the active measure of ET opening function, dilatory efficiency, or in the passive measures reflecting the magnitude of the forces that tend to hold the ET lumen closed, the opening and closing pressures, and passive trans-ET conductance. CONCLUSIONS: The results do not support the hypothesis that ET closing forces are less in ears with RAOM when compared to ears with COME, and from the results of earlier studies, ears without disease. Both groups were characterized by a low ET opening efficiency (referenced to ears of adults with no disease history). Because both disease expressions present the same pattern of ET dysfunction, other factors are required to explain why a subset of ears with that type of dysfunction develop RAOM, as opposed to the default expression of COME. LEVEL OF EVIDENCE: 2b