Tympanostomy Tubes or Medical Management for Recurrent Acute Otitis Media.

BACKGROUND: Official recommendations differ regarding tympanostomy-tube placement for children with recurrent acute otitis media. METHODS: We randomly assigned children 6 to 35 months of age who had had at least three episodes of acute otitis media within 6 months, or at least four episodes within 12 months with at least one episode within the preceding 6 months, to either undergo tympanostomy-tube placement or receive medical management involving episodic antimicrobial treatment. The primary outcome was the mean number of episodes of acute otitis media per child-year (rate) during a 2-year period. RESULTS: In our main, intention-to-treat analysis, the rate (±SE) of episodes of acute otitis media per child-year during a 2-year period was 1.48±0.08 in the tympanostomy-tube group and 1.56±0.08 in the medical-management group (P = 0.66). Because 10% of the children in the tympanostomy-tube group did not undergo tympanostomy-tube placement and 16% of the children in the medical-management group underwent tympanostomy-tube placement at parental request, we conducted a per-protocol analysis, which gave corresponding episode rates of 1.47±0.08 and 1.72±0.11, respectively. Among secondary outcomes in the main analysis, results were mixed. Favoring tympanostomy-tube placement were the time to a first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting specified criteria for treatment failure. Favoring medical management was children's cumulative number of days with otorrhea. Outcomes that did not show substantial differences included the frequency distribution of episodes of acute otitis media, the percentage of episodes considered to be severe, and antimicrobial resistance among respiratory isolates. Trial-related adverse events were limited to those included among the secondary outcomes of the trial. CONCLUSIONS: Among children 6 to 35 months of age with recurrent acute otitis media, the rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management. (Funded by the National Institute on Deafness and Other Communication Disorders and others; ClinicalTrials.gov number, NCT02567825.).

Pediatric tympanostomy tube assessment via deep learning.

PURPOSE: Tympanostomy tube (TT) placement is the most frequently performed ambulatory surgery in children under 15. After the procedure it is recommended that patients follow up regularly for "tube checks" until TT extrusion. Such visits incur direct and indirect costs to families in the form of days off from work, copays, and travel expenses. This pilot study aims to compare the efficacy of tympanic membrane (TM) evaluation by an artificial intelligence algorithm with that of clinical staff for determining presence or absence of a tympanostomy tube within the TM. METHODS: Using a digital otoscope, we performed a prospective study in children (ages 10 months-10 years) with a history of TTs who were being seen for follow up in a pediatric otolaryngology clinic. A smartphone otoscope was used by study personnel who were not physicians to take ear exam images, then through conventional otoscopic exam, ears were assessed by a clinician for tubes being in place or tubes having extruded from the TM. We trained and tested a deep learning (artificial intelligence) algorithm to assess the images and compared that with the clinician's assessment. RESULTS: A total of 123 images were obtained from 28 subjects. The algorithm classified images as TM with or without tube in place. Overall classification accuracy was 97.7 %. Recall and precision were 100 % and 96 %, respectively, for TM without a tube present, and 95 % and 100 %, respectively, for TM with a tube in place. DISCUSSION: This is a promising deep learning algorithm for classifying ear tube presence in the TM utilizing images obtained in awake children using an over-the-counter otoscope available to the lay population. We are continuing enrollment, with the goal of building an algorithm to assess tube patency and extrusion.

Long-term efficacy of balloon dilation of the pediatric Eustachian tube: A six-year matched cohort study.

PURPOSE: Balloon dilation of the Eustachian tube (BDET) has not been evaluated extensively in children outside of retrospective case series. The purpose of this study is to report the long-term safety and efficacy of this procedure in children with matched controls. MATERIALS AND METHODS: This is a two-center retrospective matched cohort study. Children having undergone tympanostomy tube (TT) placement and adenoidectomy with recurrence of symptoms underwent BDET at an academic affiliated multi-specialty practice. Comparison was made with children receiving TT at a tertiary medical center, matching for number of prior TT, prior adenoidectomy, age, and sex. Outcome measures were risk of failure and the need for additional surgery. Kaplan-Meier survival plots were used to compare risk of failure. RESULTS: Thirty-three Eustachian tubes were dilated in 20 patients, aged 14 months-14 years. All patients had previously undergone TT insertion and adenoidectomy. Patients undergoing BDET had normal post-operative tympanograms in 80 % of cases. Mean follow up was 6.7 years with 2 patients failing in the BDET group and 8 in the TT insertion group. Dilated patients had a significantly lower risk of failure than those who underwent TT insertion (adjusted HR: 0.18; 95 % CI: 0.04, 0.81; p = 0.03). The probability of being failure free at six years was 88 % (95 % CI: 71, 95 %) in the BDET cohort and 53 % (95 % CI: 33, 70 %) in the TT insertion cohort. There were no complications. CONCLUSIONS: BDET appears to be safe and possibly superior to TT placement in children with refractory Eustachian tube dysfunction. LEVEL OF EVIDENCE: 2b.

Efficacy of balloon Eustachian tuboplasty plus tympanostomy tube insertion in postirradiation otitis media with effusion.

OBJECTIVE: This study aimed to compare the efficacy of balloon Eustachian tuboplasty (BET) plus tympanostomy tube insertion (TTI) and simple TTI for postirradiation otitis media with effusion (OME) in patients with nasopharyngeal carcinoma. METHOD: This study included 36 patients (51 ears) with OME after the first radiotherapy course for nasopharyngeal carcinoma and categorized them into the BET + TTI and simple TTI groups. Effective rates, pure tone hearing threshold, Eustachian tube function score, and complication incidences were compared. RESULTS: The effective rates of the BET+TTI and TTI groups were 93.75 % and 75 %, respectively, with no statistically significant difference (P = 0.29). The pure tone hearing threshold examination at 9 months postoperatively revealed significantly lower mean air-pure tone and air-bone gap in both the BET + TTI and TTI groups than preoperatively. Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores at every postoperative visit were significantly higher than preoperative scores in the two groups (all P < 0.05); ETDQ-7 score reduction in the BET + TTI group at 3, 9, and 12 months postoperatively was significantly higher than that in the TTI group. Otorrhea and recurrence both occurred in the BET+TTI and TTI groups, but the BET+TTI group demonstrated a lower incidence. CONCLUSION: BET + TTI is an effective treatment method for postirradiation OME.

Tympanomastoidectomy versus parenteral antibiotic therapy for pediatric otorrhea.

OBJECTIVE: To evaluate the efficacy of tympanomastoidectomy versus parenteral antibiotic therapy for otorrhea as a result of chronic suppurative otitis media (CSOM) without cholesteatoma in the pediatric population. METHODS: A retrospective review of 221 patients treated for otorrhea at a tertiary academic pediatric hospital was performed to evaluate the impact of tympanomastoidectomy versus parenteral antibiotic therapy on resolution of otorrhea. Inclusion criteria were age 0-18 years, prior treatment with otic and/or oral antibiotic, prior history of tympanostomy tube placement for recurrent otitis media, history of otorrhea, treatment with tympanomastoidectomy or parenteral antibiotic therapy, and follow-up of at least 1 month after intervention. Time to resolution was compared between the two modalities adjusting for age, bilateral ear disease status, and comorbidities using a Cox proportional hazard model. RESULTS: Eighty-three ears from 58 children met the inclusion criteria. Ears that initially underwent tympanomastoidectomy had a significantly shorter time to resolution of symptoms (median time to resolution) 9 months (95 % confidence interval CI: 6.2-14.8) vs. 48.5 months (95 % lower CI 9.4, p = 0.006). On multivariate analysis, however, only bilateral ear disease status was independently associated with time to resolution of symptoms (hazard ratio 0.4, 95 % CI 0.2-0.9, p = 0.03). There was no statistically significant difference in the rate of treatment-related complications when comparing tympanomastoidectomy to parenteral antibiotic therapy (p = 0.37). CONCLUSION: When adjusting for age, bilateral ear disease status, and comorbidities, there does not appear to be a significant difference in time to resolution of symptoms when comparing parenteral antibiotic therapy to tympanomastoidectomy. An informed discussion regarding risks and benefits of each approach should be employed when deciding on the next step in management for patients with CSOM who have failed more conservative therapies.

The presence of a submucous cleft palate in patients with isolated cleft lip and middle ear dysfunction.

PURPOSE: Recent studies have suggested that children with an isolated cleft lip (CL) are more likely to develop middle ear disease and eustachian tube dysfunction (ETD) compared to the general population. This may be related to abnormal palatal musculature or an undiagnosed submucosal cleft palate (SMCP). We aim to determine the prevalence of SMCP in patients with CL who exhibit ETD. MATERIALS AND METHODS: A retrospective chart review was performed for children with an isolated CL requiring tympanostomy tubes over a 20-year period at an academic tertiary care medical center. Demographic, clinical, and surgical data were collected. RESULTS: Three hundred twelve patients had an isolated CL, and 29 (9.3 %) children required tympanostomy tubes. Of those, nine (31 %) were found to have a SMCP (7 males, 6 Caucasian). The average age at CL repair was 3.94 ± 1.03 months, and the average age at tympanostomy tube placement was 13.68 ± 13.8 months. All nine patients had chronic otitis media, with four having mild conductive hearing loss and three having moderate conductive hearing loss. The SMCP was diagnosed at the time of CL diagnosis (4), after CL diagnosis with the diagnosis of chronic otitis media/ETD (2) and after a diagnosis of chronic otitis media/ETD. CONCLUSION: Middle ear disease or eustachian tube dysfunction in a patient with an isolated cleft lip should raise suspicion for an accompanying undiagnosed SMCP.

Impact of ventilation tube insertion on long-term language outcomes at 6 and 10 years of age: A prospective pregnancy cohort study.

OBJECTIVE: Investigating the impact of early childhood ventilation tube insertion (VTI) on long-term language outcomes. DESIGN: Longitudinal cohort study. SETTING: A total of 2900 pregnant women participated in the Raine Study between 1989 and 1991 in Western Australia, and 2868 children have been followed up. PARTICIPANTS: Based on parental reports, 314 children had a history of recurrent otitis media but did not undergo VTI (rOM group); another 94 received VTI (VTI group); while 1735 had no history of rOM (reference group) in the first 3 years of childhood. Children with data on outcomes and confounders were included in analyses of PPVT-R at ages 6 (n = 1567) and 10 years (n = 1313) and CELF-III at 10 years (n = 1410) (approximately 5% in the VTI group and 15% in the rOM group). MAIN OUTCOME MEASURES: Peabody Picture Vocabulary Test-Revised edition and Clinical Evaluation of Language Fundamentals® Preschool-3. RESULTS: At 6 years, mean PPVT-R scores were significantly lower in the VTI group than the reference group (ß = -3.3; 95% CI [-6.5 to -0.04], p = .047). At 10 years, while the difference between the VTI and reference groups was less pronounced for PPVT-R scores, there was a small but consistent trend of lower measures, on average, across CELF-III scores (expressive: ß = -3.4 [-7.1 to 0.27], p = .069; receptive: ß = -4.1 [-7.9 to -0.34], p = .033; total: ß = -3.9 [-7.5 to -0.21], p = .038). There was no evidence to suggest that language outcomes in the rOM group differed from the reference group. CONCLUSION: Lower scores of language outcomes in school-aged children who received VTI in early childhood may suggest a long-term risk which should be considered alongside the potential benefits of VTI.

Retrospective observational study analysing the trends in ventilation tube insertion in children in Scotland between 2001 and 2018.

OBJECTIVES: Otitis media with effusion (OME) is common, affecting up to 90% of children. Around 25% will have a persistent effusion with conductive hearing loss which can impact their development. Ventilation tubes (VTs) can improve their hearing in the short term. This study aims to analyse the trends in VT insertion rates across Scotland. DESIGN: Retrospective observational study. SETTING: All mainland Scottish health boards. PARTICIPANTS: All children aged 0-16 who underwent a VT insertion procedure from 2001 to 2018 were included. MAIN OUTCOME MEASURES: Data were provided by the Scottish Public Health Observatory, using Scottish Morbidity Records. Mid-year population estimates were obtained from the National Records Office of Scotland. Socioeconomic deprivation was estimated based on area of residence using the Scottish Index of Multiple Deprivation. VT insertion rates were calculated and trends analysed. RESULTS: A total of 35 878 VT procedures were performed in total with a mean rate of 2.02 per 1000 children per year. The highest insertion rates were observed in children aged 4-6. VT insertion rates reduced during the study period (R = -0.729, p = .001). Variability in VT insertion rates between health boards reduced. There was a significant association between socioeconomic deprivation and VT insertion rate, with the most deprived children having the highest rate (p < .001). CONCLUSIONS: VT insertion rates and the variability between Scottish health boards have reduced over the past two decades, suggesting a more equitable system. Our data intimates that the decision to perform VT insertion is based upon disease prevalence rather than clinician preference.

Cost-Effectiveness of Management Strategies in Recurrent Acute Otitis Media.

OBJECTIVE: To evaluate the cost-effectiveness of tympanostomy tube placementvs nonsurgical medical management, with the option of tympanostomy tube placement in the event of treatment failure, in children with recurrent acute otitis media (AOM). STUDY DESIGN: A Markov decision model compared management strategies in children ages 6-35 months, using patient-level data from a recently completed, multicenter, randomized clinical trial of tympanostomy tube placement vs medical management. The model ran over a 2-year time horizon using a societal perspective. Probabilities, including risk of AOM symptoms, were derived from prospectively collected patient diaries. Costs and quality-of-life measures were derived from the literature. We performed one-way and probabilistic sensitivity analyses, and secondary analyses in predetermined low- and high-risk subgroups. The primary outcome was incremental cost per quality-adjusted life-year gained. RESULTS: Tympanostomy tubes cost $989 more per child than medical management. Children managed with tympanostomy tubes gained 0.69 more quality-adjusted life-days than children managed medically, corresponding to $520 855 per quality-adjusted life-year gained. Results were sensitive to the costs of oral antibiotics, missed work, special childcare, the societal cost of antibiotic resistance, and the quality of life associated with AOM. In probabilistic sensitivity analyses, medical management was favored in 66% of model iterations at a willingness-to-pay threshold of $100 000/quality-adjusted life-year. Medical management was preferred in secondary analyses of low- and high-risk subgroups. CONCLUSIONS: For young children with recurrent AOM, the additional cost associated with tympanostomy tube placement outweighs the small improvement in quality of life. Medical management for these children is an economically reasonable strategy. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT02567825.

Audiometric Outcomes of Ventilation Drainage Treatment for Otitis Media with Effusion in Children: Implications for Speech Development and Hearing Loss.

BACKGROUND Otitis media with effusion is the most commonly recognized condition in childhood. Chronic otitis media with accompanying hearing loss is particularly unfavorable in the first years of the child's life because it can not only permanently damage the structure of the middle ear, but also adversely affect speech development and intellectual abilities in the child. MATERIAL AND METHODS This study, from a single center in Poland, included 201 children (372 ears) requiring surgical treatment due to otitis media with effusion. The condition was diagnosed by an ear, nose, and throat specialist, and each patient had a hearing test performed. The control group consisted of 21 patients (42 ears) with negative outcomes following an audiological interview. RESULTS Among all of the patients enrolled in the study, a normal tympanometry result was found in 60.6% of ears, and otoemission occurred in 63.3% of ears. The average hearing threshold in the study group was 22.01 Hz in the 500 Hz frequency range, while they were 16.76 Hz, 12.72 kHz, and 14.78 kHz for the corresponding 1 kHz, 2 kHz, and 4 kHz ranges, respectively. CONCLUSIONS Ventilation drainage is an effective treatment for otitis media with effusion. The presence of genetic disease has the greatest impact on the course of otitis media. These patients most often require reinsertion of a ventilation tube.

Low-temperature plasma radiofrequency ablation tuboplasty and myringotomy: A preliminary report.

OBJECTIVE: To evaluate the efficacy of Low-temperature plasma radiofrequency ablation (RF) tuboplasty and myringotomy for treating chronic otitis media with effusion (COME) with chronic obstructive eustachian tube dysfunction (COETD) involving hypertrophic tissue of the ET orifice. METHODS AND MATERIALS: This was a prospective study of 43 ears with COME and COETD who underwent RF tuboplasty. Outcomes included the ability to perform a Valsalva maneuver, tympanometry results, and TM status. Success was defined by an improvement in tympanogram type and Valsalva maneuver. Follow-up ranged from 4 weeks to 12 months. RESULTS: A total of 43 ears (43 patients) were included in the study. Mucosal hypertrophy of the ET orifice was seen in 35 (81.4 %) patients, while polypoid tissue was observed in 8 (18.6 %) patients. All patients completed the 12-month follow-up, the success rate was 95.3 % (41/43) at postoperative 3 months, 39/43 (90.4 %) at postoperative 6 months, and 37/43 (86.0 %) at postoperative 12 months. No procedure-related serious adverse events were reported for any patient, and there were no cases of patulous ET. Stenosis/scar of anterior-post wall in the ET orifice occurred in two patients at 6 months postoperatively and in one patient at 12 months postoperatively, which the Valsalva maneuver was positive. Thus, no further treatment was applied for the ET orifice in 3 patients. The risk of stenosis of the ET orifice was 3/47 (6.4 %). CONCLUSIONS: RF eustachian tuboplasty may be an effective treatment for patients with COME, COETD and hypertrophic mucosa in the ET orifice, particularly as an adjunct to balloon tuboplasty.

The association between Helicobacter pylori and chronic otitis media with effusion.

PURPOSE: Chronic otitis media with effusion (COME) is a common condition in children and a leading cause for hearing loss and ventilation tubes (VT) insertion. Among other risk factors, it is suggested that Helicobacter pylori (H. pylori) infection may have a role in the pathogenesis of COME. Previous studies have reached different results, and therefore, there is a need for further data on the relationship between H. pylori infection and COME development in children. Our objective is to investigate the presence of H. pylori in the middle-ear fluid (MEF) from children with COME. METHODS: A Comparative cross-sectional study. Children ≤ 18 years were included. The study group included children diagnosed with COME and required VT insertion. The control group included children with acute otitis media (AOM) who required myringotomy in the emergency room. Middle-ear fluid samples were sent for both culture and bacterial identification using polymerase chain reaction (PCR) testing. RESULTS: A total of 43 children were included. Eighteen with COME (median age 4 years, IQR 3-6), and 25 with AOM (median age 1 year, IQR 1-2). All samples were cultured for H. pylori. Twenty-two samples underwent H. pylori PCR testing of them, 12 samples from children with COME, and 10 from children with AOM. All cultures and PCR tests results were negative for H. pylori. CONCLUSIONS: Our results suggest that H. pylori does not have a role in the pathogenesis of COME. Future larger studies are needed to investigate whether H. pylori has a role in the pathogenesis of COME.

Tympanostomy Tubes: Are They Necessary? A Systematic Review on Implementation in Cleft Care.

OBJECTIVE: To understand the indication for and the effects of early ventilation tube insertion (VTI) on hearing and speech for patients with cleft lip and/or palate (CLP). DESIGN: We conducted a Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA)-guided systematic review of relevant literature. SETTING: Setting varied by geographical location and level of clinical care across studies. PATIENTS, PARTICIPANTS: Patients with CLP who underwent VTI were included. INTERVENTIONS: No interventions were performed. MAIN OUTCOME MEASURE(S): Primary outcome measures were hearing and speech following VTI. Secondary outcome measures were tube-related and middle ear complications. Early VTI occurred before or at time of palatoplasty while late VTI occurred after palatoplasty. RESULTS: Twenty-three articles met inclusion criteria. Articles varied among study design, outcome measures, sample size, follow-up, and quality. Few studies demonstrated support for early VTI. Many studies reported no difference in hearing or speech between early and late VTI. Others reported worse outcomes, greater likelihood of complications, or needing repeat VTI following early tympanostomy placement. Several studies had significant limitations, including confounding variables, small sample size, or not reporting on our primary outcome. CONCLUSIONS: No consistency was found regarding which patients would benefit most from early VTI. Given the aforementioned variability and sub-optimal methodologies, additional studies are warranted to provide stronger evidence regarding VTI timing in cleft care.

Formula Otorrhea in Pediatric Patients With Cleft Palate.

The case series details 2 unusual cases of male newborns with cleft lip and palate (CLP) that later developed formula otorrhea. Both patients underwent bilateral myringotomies with the insertion of pressure equalizing (PE) tubes for chronic otitis media with effusion (OME). Chronic otorrhea associated with feeding occurred post-PE tube insertion and the otorrhea was later confirmed to be due to reflux of formula. Patients were treated with antibiotic ear drops, routine ear cleaning, anti-reflux medication, and reflux precautions. After definite cleft palate repair, formula otorrhea completely resolved. When patients with CLP develop chronic OME or otorrhea following PE tube placement, reflux of formula into the middle ear should be considered and treated accordingly.

CHARACTERISTICS OF HEARING RECOVERY IN CHILDREN WITH CHRONIC OTITIS MEDIA WITH EFFUSION AFTER VENTILATION TUBE INSERTION.

The objective was to determine the range of hearing improvement (in dB) post ventilation tube insertion in children with chronic otitis media with effusion (COME), and whether there was a difference in hearing improvement between age groups and genders. This study also investigated whether there was a difference in the mean hearing improvement between the left and right ear, how many months passed before recovery of eustachian tube function, and how long the aeration of the middle ear lasted. The children included in the study were between six and twelve years of age, diagnosed with COME by audiological processing (type B tympanometric recording and conductive hearing loss up to 40 dB on pure tone audiometry) and underwent surgical insertion of ventilation tubes in both ears. Patient data included preoperative tympanometric records, preoperative and postoperative tone audiometry findings, tubometry findings 6 and 10 months after insertion of ventilation tubes, age and gender data, and length of time during which the tubes were in place. The mean hearing improvement of the included patients was 24.2 dB on the right ear and 24.5 dB on the left ear. There was no statistically significant difference between the left and right ear or between the genders. Older age groups had a higher mean hearing improvement compared with the younger age group. Younger age groups had a longer expected period of eustachian tube function recovery, and were expected to have ventilation tubes inserted for a longer period of time. Treatment with ventilation tube insertion resulted in significant improvement in hearing in children where previous conservative therapy failed to recover eustachian tube function and improve hearing. Although children of older age groups had greater preoperative hearing impairment, the recovery of both eustachian tube function and hearing improvement was faster, and the mean length of time that the ventilation tubes had to be inserted was shorter.

[Effectiveness of baloon dilation of Eustachian tube in children with otitis media with effusion]. / Effektivnost' ballonnoi dilatatsii slukhovoi truby u detei s khronicheskim ekssudativnym srednim otitom.

Otitis media with effusion is one of the most common ENT diseases in childhood. Absence of acute symptoms, prevalence of pathology among preschoolers, who often cannot complain on discomfort in the ears and hearing loss, lead to late diagnosis and treatment. Standard surgery is highly effective, but it is not able to help all patients. A new, minimally invasive technique of surgical treatment of otitis media with effusion - balloon dilation of the Eustachian tube provides additional opportunities in solving these problems. OBJECTIVE: To evaluate the effectiveness and possibilities of its increasing in balloon dilation of the auditory tube in children with chronic otitis media with effusion. 34 children with chronic otitis media with effusion were under observation, who underwent 54 operations using a balloon catheter for the auditory tubes. The mismatch between the pressure value and the baloon diameter has been experimentally shown, and therefore a technique for intraoperative control of the effectiveness of the procedure has been developed. The effectiveness of balloon dilation in the study was 30.8-64.3%, depending on the following factors: the stage of otitis media at which the treatment was carried out, the combination of balloon dilation with tympanostomy, the use of intraoperative efficiency control technique. The high safety of the operation and the possibility of its effective implementation in patients with an operated cleft-palate are shown.

The necessity and effect of prophylactic quinolone ear drops after ventilation tube insertion for otitis media with effusion.

BACKGROUND: Otitis media with effusion (OME) is a condition where non-infective fluid builds up in the middle ear. Long-term OME can cause damage to the middle ear and hearing impairment. Ventilation tube insertion (VTI) is an efficient procedure to drain persistent OME. However, the effect of prophylactic ear drops after VTI remains controversial because no infection is present. This study investigated the need for and effect of quinolone ear drops in patients with OME after VTI. METHODS: Between July 2018 and July 2021, 272 patients (436 ears with OME) who underwent VTI were enrolled. Prophylactic quinolone ear drops (ofloxacin) were used in 271 OME ears and not used in 165. The clinical findings and effect of the ear drops were assessed. RESULTS: The group with postoperative ofloxacin had less postoperative otorrhea (p < 0.001). In univariate analysis, age ≥ 13 years (odds ratio [OR] = 1.499, 95% confidence interval [CI]: 1.003-2.238, p = 0.046) was significantly associated with recovery to normal middle ear functioning (type A on postoperative tympanometry). No adenoid hypertrophy (OR = 1.692, 95% CI: 1.108-2.585, p = 0.014) and no postoperative otorrhea (OR = 2.816, 95% CI: 1.869-4.237, p < 0.001) were significant independent factors associated with middle ear recovery in both univariate and multivariate analysis. After VTI, 65% of tympanic membranes in the group with postoperative ofloxacin recovered to normal, while in 67% of tympanic membranes in the group without ofloxacin scarring remained. CONCLUSIONS: Patients who received prophylactic postoperative ofloxacin had less postoperative otorrhea. No adenoid hypertrophy and no postoperative otorrhea were significant independent predictors of middle ear recovery to normal function in both univariate analysis and multivariate analysis. However, prophylactic ofloxacin was not an independent predictor of normal middle ear functioning after VTI. After VTI, most OME patients who had used ofloxacin postoperatively had eardrums that were in better condition than those of patients who had not used ofloxacin. In this study, we confirmed the advantages and limitations of OME after VTI with prophylactic ofloxacin, thus providing clinicians with some guidance regarding the decision to administer prophylactic ofloxacin.

The limits of pandemic precautions: Tympanostomy tube placement in children with cleft palate during COVID-19.

PURPOSE: Coronavirus Disease-2019 (COVID-19) mitigation measures have led to a sustained reduction in tympanostomy tube (TT) placement in the general population. The present aim was to determine if TT placement has also decreased in children at risk for chronic otitis media with effusion (COME), such as those with cleft palate (CP). MATERIALS AND METHODS: A cohort study with medical record review was performed including consecutive children, ages 0-17 years, undergoing primary palatoplasty at a tertiary children's hospital February 2019-January 2020 (pre-COVID) or May 2020-April 2021 (COVID). Revision palatoplasty (n = 29) was excluded. Patient characteristics and middle ear status pre-operatively and at palatoplasty were compared between groups using logistic regression or Wilcoxon rank-sum. RESULTS: The pre-COVID and COVID cohorts included 73 and 87 patients, respectively. Seventy (44%) were female and median age at palatoplasty was 13.5 months for CP ± cleft lip (CP ± L) and 5.5 years for submucous cleft palate (SMCP). In patients with CP ± L, TT were placed or in place and patent at palatoplasty in 28/38 (74%) pre-COVID and 37/50 (74%) during COVID (P = 0.97). In patients with SMCP, these proportions were 5/35 (14%) and 6/37 (16%), respectively (P = 0.82). Examining only patients <2 years of age also revealed no difference in TT placement pre-COVID versus COVID (P = 0.99). Finally, the prevalence and type of effusion during COVID was similar to pre-COVID. CONCLUSIONS: Reduced infectious exposure has not decreased TT placement or effusion at palatoplasty. Future work could focus on non-infectious immunologic factors underlying the maintenance of COME in these children.

Oxymetazoline vs ofloxacin vs ciprofloxacin/dexamethasone- effects of drops on tympanostomy tube postoperative otorrhea.

OBJECTIVE: To assess for differences in postoperative otorrhea rates after tympanostomy with tube placement surgery comparing use of oxymetazoline, ofloxacin, or ciprofloxacin/dexamethasone drops prescribed in the postoperative period. METHODS: A retrospective review was conducted of 516 pediatric patients who had either bilateral or unilateral myringotomy with tube placement performed during the year 2018. Information collected from each surgery included whether there was effusion at time of surgery, type of effusion, whether an adenoidectomy was performed the same time or prior, prior history of tube placement, style of tube placed, type of drop given or prescribed on the day of surgery. Demographic information including age, sex, race, weight was recorded as well. Finally, the postoperative visit was analyzed for presence of otorrhea in the ears that had surgery. Univariate analysis was conducted to see if there was any association between the three different drops and presence of otorrhea postoperatively. RESULTS: Postoperative otorrhea was present in 50 of the 516 patients (9.7 %). We observed no significant difference between the type of drop used and postoperative otorrhea being present (p = 0.179), but prior placement of tubes was significantly correlated to postoperative otorrhea (p < 0.001). There was no relationship between type of tube used, prior tube placement, or history of adenoidectomy with type of ear drop used. CONCLUSION: Overall, there is no significant difference in the rate of postoperative otorrhea when choosing between oxymetazoline, ofloxacin, or ciprofloxacin/dexamethasone drops for use in the postoperative period after tympanostomy tube placement.

Management of tympanic membrane retractions: a systematic review.

IMPORTANCE: Tympanic membrane retraction (TMR) is a relatively common otological finding. However, no consensus on its management exists. We are looking especially for a treatment strategy in the military population who are unable to attend frequent follow-up visits, and who experience relatively more barotrauma at great heights and depths and easily suffer from otitis externa from less hygienic circumstances. OBJECTIVE: To assess and summarize the available evidence for the effectiveness of surgical interventions and watchful waiting policy in patients with a tympanic membrane retraction. EVIDENCE REVIEW: The protocol for this systematic review was published at Prospero (207859). PubMed, Embase, and the Cochrane Database of Systematic Reviews were systematically searched from inception up to September 2020 for published and unpublished studies. We included randomized trials and observational studies that investigated surgical interventions (tympanoplasty, ventilation tube insertion) and wait-and-see policy. The primary outcomes of this study were clinical remission of the tympanic membrane retraction, tympanic membrane perforations and cholesteatoma development. FINDINGS: In total, 27 studies were included, consisting of 1566 patients with TMRs. We included data from 2 randomized controlled trials (76 patients) and 25 observational studies (1490 patients). Seven studies (329 patients) investigated excision of the TMR with and without ventilation tube placement, 3 studies (207 patients) investigated the wait-and-see policy and 17 studies (1030 patients) investigated tympanoplasty for the treatment of TMRs. CONCLUSIONS AND RELEVANCE: This study provides all the studies that have been published on the surgical management and wait-and-policy for tympanic membrane retractions. No high level of evidence comparative studies has been performed. The evidence for the management of tympanic membrane retractions is heterogenous and depends on many factors such as the patient population, location and severity of the TMR and presence of other ear pathologies (e.g., perforation, risk of cholesteatoma and serous otitis media).