The update group made strong recommendations that clinicians (1) should document the presence of middle ear effusion with pneumatic otoscopy when diagnosing OME in a child; (2) should perform pneumatic otoscopy to assess for OME in a child with otalgia, hearing loss, or both; (3) should obtain tympanometry in children with suspected OME for whom the diagnosis is uncertain after performing (or attempting) pneumatic otoscopy; (4) should manage the child with OME who is not at risk with watchful waiting for 3 months from the date of effusion onset (if known) or 3 months from the date of diagnosis (if onset is unknown); (5) should recommend against using intranasal or systemic steroids for treating OME; (6) should recommend against using systemic antibiotics for treating OME; and (7) should recommend against using antihistamines, decongestants, or both for treating OME.The update group made recommendations that clinicians (1) should document in the medical record counseling of parents of infants with OME who fail a newborn screening regarding the importance of follow-up to ensure that hearing is normal when OME resolves and to exclude an underlying sensorineural hearing loss; (2) should determine if a child with OME is at increased risk for speech, language, or learning problems from middle ear effusion because of baseline sensory, physical, cognitive, or behavioral factors; (3) should evaluate at-risk children for OME at the time of diagnosis of an at-risk condition and at 12 to 18 months of age (if diagnosed as being at risk prior to this time); (4) should not routinely screen children for OME who are not at risk and do not have symptoms that may be attributable to OME, such as hearing difficulties, balance (vestibular) problems, poor school performance, behavioral problems, or ear discomfort; (5) should educate children with OME and their families regarding the natural history of OME, need for follow-up, and the possible sequelae; (6) should obtain an age-appropriate hearing test if OME persists for 3 months or longer OR for OME of any duration in an at-risk child; (7) should counsel families of children with bilateral OME and documented hearing loss about the potential impact on speech and language development; (8) should reevaluate, at 3- to 6-month intervals, children with chronic OME until the effusion is no longer present, significant hearing loss is identified, or structural abnormalities of the eardrum or middle ear are suspected; (9) should recommend tympanostomy tubes when surgery is performed for OME in a child <4 years old; adenoidectomy should not be performed unless a distinct indication exists (nasal obstruction, chronic adenoiditis); (10) should recommend tympanostomy tubes, adenoidectomy, or both when surgery is performed for OME in a child ≥4 years old; and (11) should document resolution of OME, improved hearing, or improved quality of life when managing a child with OME.

Structured Abstract Objectives To develop normative data for wideband middle-ear reflectance in a newborn hearing-screening population, and to compare test performance with 1-kHz tympanometry for prediction of OAE screening outcome. Design Wideband middle-ear reflectance (using both tone and chirp stimuli over 0.2 to 6 kHz), 1-kHz tympanometry, and distortion-product otoacoustic emissions (DPs) were measured in 324 infants at two test sites. Ears were categorized into DP-pass and DP-refer groups. Results Normative reflectance values were defined over various frequency regions for both tone and chirp stimuli in ambient pressure conditions, and for reflectance area indices (RAIs) integrated over various frequency ranges. Receiver-operating-characteristic (ROC) analyses showed that reflectance provides the best discriminability of DP status in frequency ranges involving 2 kHz, and greater discriminability of DP status than 1-kHz tympanometry. Repeated-measures analyses of variance (ANOVA) established that (a) there were significant differences in reflectance as a function of DP status and frequency, but not sex or ear; (b) tone and chirp stimulus reflectance values are essentially indistinguishable, and (c) newborns from two geographic sites had similar reflectance patterns above 1-kHz. Birth type and weight did not contribute to differences in reflectance. Conclusions Referrals in OAE-based infant hearing screening were strongly associated with increased wideband reflectance, suggesting middle-ear dysfunction at birth. Reflectance improved significantly over the first 4 days after birth with normalization of middle-ear function. Reflectance scores can be achieved within seconds using the same equipment used for OAE screening. Newborns with high reflectance scores at Stage I screening should be rescreened within a few hours to a few days, as most middle-ear problems are transient and resolve spontaneously. If reflectance and OAE are not passed upon Stage II screening, referral to an otologist for ear examination is suggested along with diagnostic testing. Newborns with normal reflectance and a refer result for the OAE screen should be referred immediately to an audiologist for diagnostic testing with threshold auditory brainstem response (ABR) due to higher risk for permanent hearing loss.

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Objective Insertion of tympanostomy tubes is the most common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections, or ear infections that persist after antibiotic therapy. All these conditions are encompassed by the term otitis media (middle ear inflammation). This guideline update provides evidence-based recommendations for patient selection and surgical indications for managing tympanostomy tubes in children. The guideline is intended for any clinician involved in managing children aged 6 months to 12 years with tympanostomy tubes or children being considered for tympanostomy tubes in any care setting as an intervention for otitis media of any type. The target audience includes specialists, primary care clinicians, and allied health professionals. Purpose The purpose of this clinical practice guideline update is to reassess and update recommendations in the prior guideline from 2013 and to provide clinicians with trustworthy, evidence-based recommendations on patient selection and surgical indications for managing tympanostomy tubes in children. In planning the content of the updated guideline, the guideline update group (GUG) affirmed and included all the original key action statements (KASs), based on external review and GUG assessment of the original recommendations. The guideline update was supplemented with new research evidence and expanded profiles that addressed quality improvement and implementation issues. The group also discussed and prioritized the need for new recommendations based on gaps in the initial guideline or new evidence that would warrant and support KASs. The GUG further sought to bring greater coherence to the guideline recommendations by displaying relationships in a new flowchart to facilitate clinical decision making. Last, knowledge gaps were identified to guide future research. Methods In developing this update, the methods outlined in the American Academy of Otolaryngology–Head and Neck Surgery Foundation’s “Clinical Practice Guideline Development Manual, Third Edition: A Quality-Driven Approach for Translating Evidence Into Action” were followed explicitly. The GUG was convened with representation from the disciplines of otolaryngology–head and neck surgery, otology, pediatrics, audiology, anesthesiology, family medicine, advanced practice nursing, speech-language pathology, and consumer advocacy. Action Statements The GUG made strong recommendations for the following KASs: (14) clinicians should prescribe topical antibiotic ear drops only, without oral antibiotics, for children with uncomplicated acute tympanostomy tube otorrhea; (16) the surgeon or designee should examine the ears of a child within 3 months of tympanostomy tube insertion AND should educate families regarding the need for routine, periodic follow-up to examine the ears until the tubes extrude. The GUG made recommendations for the following KASs: (1) clinicians should not perform tympanostomy tube insertion in children with a single episode of otitis media with effusion (OME) of less than 3 months’ duration, from the date of onset (if known) or from the date of diagnosis (if onset is unknown); (2) clinicians should obtain a hearing evaluation if OME persists for 3 months or longer OR prior to surgery when a child becomes a candidate for tympanostomy tube insertion; (3) clinicians should offer bilateral tympanostomy tube insertion to children with bilateral OME for 3 months or longer AND documented hearing difficulties; (5) clinicians should reevaluate, at 3- to 6-month intervals, children with chronic OME who do not receive tympanostomy tubes, until the effusion is no longer present, significant hearing loss is detected, or structural abnormalities of the tympanic membrane or middle ear are suspected; (6) clinicians should not perform tympanostomy tube insertion in children with recurrent acute otitis media who do not have middle ear effusion in either ear at the time of assessment for tube candidacy; (7) clinicians should offer bilateral tympanostomy tube insertion in children with recurrent acute otitis media who have unilateral or bilateral middle ear effusion at the time of assessment for tube candidacy; (8) clinicians should determine if a child with recurrent acute otitis media or with OME of any duration is at increased risk for speech, language, or learning problems from otitis media because of baseline sensory, physical, cognitive, or behavioral factors; (10) the clinician should not place long-term tubes as initial surgery for children who meet criteria for tube insertion unless there is a specific reason based on an anticipated need for prolonged middle ear ventilation beyond that of a short-term tube; (12) in the perioperative period, clinicians should educate caregivers of children with tympanostomy tubes regarding the expected duration of tube function, recommended follow-up schedule, and detection of complications; (13) clinicians should not routinely prescribe postoperative antibiotic ear drops after tympanostomy tube placement; (15) clinicians should not encourage routine, prophylactic water precautions (use of earplugs or headbands, avoidance of swimming or water sports) for children with tympanostomy tubes. The GUG offered the following KASs as options: (4) clinicians may perform tympanostomy tube insertion in children with unilateral or bilateral OME for 3 months or longer (chronic OME) AND symptoms that are likely attributable, all or in part, to OME that include, but are not limited to, balance (vestibular) problems, poor school performance, behavioral problems, ear discomfort, or reduced quality of life; (9) clinicians may perform tympanostomy tube insertion in at-risk children with unilateral or bilateral OME that is likely to persist as reflected by a type B (flat) tympanogram or a documented effusion for 3 months or longer; (11) clinicians may perform adenoidectomy as an adjunct to tympanostomy tube insertion for children with symptoms directly related to the adenoids (adenoid infection or nasal obstruction) OR in children aged 4 years or older to potentially reduce future incidence of recurrent otitis media or the need for repeat tube insertion.

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Wideband middle ear power (WMEP) measurement is a method of middle ear analysis that may provide improved diagnostic capability over single-frequency tympanometry. However, normative data, information about test-retest reliability, and results in clinical disorders are needed for clinical application. Normative and reliability data on WMEP in children three days to 47 months of age were obtained using a prototype commercial instrument. A prospective study was conducted in children enrolled from a well-child pediatric clinic (n = 97), with comparisons of age, gender, and middle ear status and stimulus type (broadband chirp and sine wave). No significant age effect for power reflectance across the age range of this study was found, except at 6000 Hz. Significantly higher-power reflectance was found for ears with poor ear status, specifically otitis media with effusion. Smaller but nonsignificant differences in power reflectance were found for ears with positive and negative tympanometric peak pressure. Intraclass correlation coefficients showed significant correlations of 0.68 to 0.97 at various test frequencies using the chirp stimulus. Multivariate analysis of variance showed no significant effect of stimulus type (sine wave vs broadband chirp), ear, or gender. These results provide normative data for wideband middle ear power analysis for infants and children from birth to age four years.

Objective To evaluate the association of subretinal hyper-reflective material (SHRM) with visual acuity (VA), geographic atrophy (GA) and scar in the Comparison of Age related Macular Degeneration Treatments Trials (CATT) Design Prospective cohort study within a randomized clinical trial. Participants The 1185 participants in CATT. Methods Participants were randomly assigned to ranibizumab or bevacizumab treatment monthly or as-needed. Masked readers graded scar and GA on fundus photography and fluorescein angiography images, SHRM on time domain (TD) and spectral domain (SD) optical coherence tomography (OCT) throughout 104 weeks. Measurements of SHRM height and width in the fovea, within the center 1mm2, or outside the center 1mm2 were obtained on SD-OCT images at 56 (n=76) and 104 (n=66) weeks. VA was measured by certified examiners. Main Outcome Measures SHRM presence, location and size, and associations with VA, scar, and GA. Results Among all CATT participants, the percentage with SHRM at enrollment was 77%, decreasing to 68% at 4 weeks after treatment and 54% at 104 weeks. At 104 weeks, scar was present more often in eyes with persistent SHRM than eyes with SHRM that resolved (64% vs. 31%; p<0.0001). Among eyes with detailed evaluation of SHRM at weeks 56 (n=76) and 104 (n=66), mean [SE] VA letter score was 73.5 [2.8], 73.1 [3.4], 65.3 [3.5], and 63.9 [3.7] when SHRM was absent, present outside the central 1mm2, present within the central 1mm2 but not the foveal center, or present at the foveal center (p=0.02). SHRM was present at the foveal center in 43 (30%), within the central 1mm2 in 21 (15%) and outside the central 1mm2 in 19 (13%). When SHRM was present, the median maximum height in microns under the fovea, within the central 1 mm2 including the fovea and anywhere within the scan was 86; 120; and 122, respectively. VA was decreased with greater SHRM height and width (p<0.05). Conclusions SHRM is common in eyes with NVAMD and often persists after anti-VEGF treatment. At 2 years, eyes with scar were more likely to have SHRM than other eyes. Greater SHRM height and width were associated with worse VA. SHRM is an important morphological biomarker in eyes with NVAMD.

This article reviews research on the possible linkage of otitis media with effusion (OME) to children's hearing and development, identifies gaps, and directions for research, and discusses implications for healthcare practices. About half of children with an episode of OME experience a mild hearing loss while about 5-10% of children have moderate hearing loss. Recent prospective and randomized clinical trials suggest none to very small negative associations of OME to children's later language development. Based on both retrospective and prospective longitudinal studies, associations between OME and perceiving speech in noise and tasks that require equal binaural hearing have been reported but have not been adequately studied with regard to functional outcomes. Thus, on average, for typically developing children, OME may not be a substantial risk factor for later speech and language development or academic achievement. However, these conclusions should be interpreted cautiously, since most of these studies used OME rather than hearing loss as the independent variable (although hearing loss rather than OME is hypothesized to affect language development) and many studies did not control for important confounding variables such as socioeconomic status (SES).