The long-term efficacy and safety of balloon dilation eustachian tuboplasty combined with tympanostomy tube insertion for patients with otitis media with effusion: study protocol for a prospective randomized controlled trial.

BACKGROUND: Otitis media with effusion (OME) is a common disease in ear, nose, and throat clinics characterized by aural fullness and hearing loss and mainly caused by eustachian tube dysfunction (ETD). Tympanostomy tube insertion (TTI) is a conventional surgical treatment option that can alleviate symptoms but does not provide a definitive cure, and it is prone to recurrence. Balloon dilation eustachian tuboplasty (BDET) has become a novel procedure for the treatment of ETD, demonstrating significant potential in addressing the aforementioned limitations. However, it is not widely available in the clinic and few high-quality randomized clinical trials was conducted to investigate its long-term efficacy and security in OME. Therefore, the purpose of this study is to verify the efficacy of BDET combined with TTI for patients with OME and its prospects for providing a definitive cure. METHODS AND ANALYSIS: This is a prospective, parallel-group, single-blind, randomized controlled prospective trial. Totally 124 patients with OME will be randomized into either group A or B. Group A will receive conventional therapy (TTI) while group B will use BDET therapy in addition to TTI. Outcome assessments will take place at baseline and at the 3rd, 6th, 12th, and 24th months after surgery. The primary outcome is eustachian tube function, which will be measured by the eustachian tube dysfunction questionnaire (ETDQ-7) and eustachian tube score (ETS). The secondary outcomes include middle ear function, hearing situation, and quality of life, which will be measured by acoustic impedance measurement, pure-tone audiometry, and Chinese-version Chronic Ear Survey (CCES). The main analysis of change in the outcomes will use mixed-model with repeated measures (MMRM) analyses of variance (ANOVAs). DISCUSSION: This is the first prospective trial in Chinese populations that aims to validate the long-term efficacy and safety of BDET-combined TTI therapy in patients with OME. This parallel-group, single-blind, randomized controlled trial may provide an opportunity to decrease the recurrence rate of OME and explore a definitive cure for patients with OME. This trial's rigorous design enhances the reliability of the findings, ensuring a robust answer to the research question. In the future, the research team will further expand upon the clinical evidence and applications of the BDET combined therapy. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2400079632. Registered on 8 January 2024, https://www.chictr.org.cn/bin/project/edit?pid=214452 .

[The effect of different degrees of Eustachian tube dysfunction on hearing threshold in patients with acquired primary middle ear cholesteatoma after balloon eustachian tuboplasty].

Objective:To investigate the changes in hearing threshold of the acquired primary cholesteatoma of the middle ear with different degrees of eustachian tube dysfunction after balloon eustachian tuboplasty. Methods:This retrospective study included forty cases with middle ear cholesteatoma and eustachian tube dysfunction who underwent open mastoidectomy + tympanoplasty + balloon eustachian tuboplasty were enrolled. All patients were admitted from November 2020 to April 2022. The preoperative eustachian tube score of 0-2 were defined as the lower group, and the scores of 3-5 were defined as the higher group. Pure tone audiometry was measured preoperatively and 1, 3, 6 and 12 months postoperatively. The average value of bone conduction threshold and air conduction threshold of 250-4 000 Hz were calculated, and the air-bone gap was calculated simultaneously. SPSS 25.0 was used for statistical analysis. P<0.05 was considered statistically significant. Results:In the lower group, the air conduction threshold and air-bone gap at 3 months postoperatively were significantly decreased in comparison with those preoperatively（P<0.05），as was the air-bone gap at 6 months postoperatively（P<0.05）. In the higher group, the air conduction threshold and air-bone gap were significantly decreased at 3, 6 and 12 months postoperatively（P<0.05）. Conclusion:The air conduction threshold and air-bone gap of patients with the acquired primary cholesteatoma of the middle ear and eustachian tube dysfunction were significantly decreased after eustachian tube balloon dilatation. Hearing improvement lasted longer in patients with slight eustachian tube dysfunction.

Interpretation of the nine-step test for Eustachian tube function should consider mastoid cavity volume.

INTRODUCTION: The modified nine-step test is a classical method for evaluating Eustachian tube function. However, clinical interpretation of the increased maximal difference in middle ear pressure (mdMEP) in the modified nine-step test is unknown. We hypothesised that the different reservoir effects of the mastoid cavity can bias the results of the modified nine-step test. METHODS: A total of 108 consecutive participants (216 ears) were retrospectively screened. Of these, 55 participants (82 ears) who met the inclusion/exclusion criteria were enrolled. The volumetric results of the mastoid cavity, parameters of the modified nine-step test (mdMEP, middle ear pressure, tympanic membrane compliance), and demographic data were analysed. RESULTS: A significant negative correlation was found between mdMEP and mastoid cavity volume (R = .467, p < .001). Ears with mdMEP >70 daPa showed poor pneumatization in the mastoid cavity, with volumes less than 3000 mm3 (10th percentile of all ears analysed). Ears with mastoid cavity volumes lower than the 25th percentile showed a significantly higher mdMEP (p < .001). Patients with mastoid cavity volumes higher than the 75th percentile were significantly younger (p < .001). Multivariate regression analysis for mdMEP showed a good fit (R = .854) using factors including middle ear pressure, admittance and, most importantly, the reciprocal of mastoid volume (Beta = 0.752, p < .001). CONCLUSIONS: The mdMEP, the main parameter of the modified nine-step test, was negatively correlated with the mastoid cavity volume. Therefore, the results of the modified nine-step test should be interpreted with consideration of mastoid cavity volume.

Sound and Noise Sources in Sonotubometry: An Investigation of Eustachian Tube Assessment.

This research aims to enhance the understanding of the acoustic processes occurring during sonotubometry, a method used to assess the Eustachian tube (ET) function. Recent advancements in digital signal processing enable a more comprehensive data analysis. In this project, a silicone model of the ET was developed to systematically study the existing noise and sound sources. These measurements were then compared with recordings from human subjects. Three distinct 'noise sources' were identified, which can influence the assessment of the ET opening using transmission measurements of the imposed signal: sound leakage from the speaker, a clicking noise at the initiation of ET opening, and rumbling/swallowing noise. Through spectral analysis, it was also possible to ascertain the spectral and temporal occurrence of these sound and noise types. The silicone model exhibited remarkable similarity to the healthy human ET, making it a robust experimental model for investigating the acoustics of sonotubometry. The findings underscore the significance of delving deeper into the analysed sound, as the noise occurring during sonotubometry can be easily misconstrued as an actual ET opening. Particularly, careful consideration is warranted when evaluating data involving clicking and swallowing noise.

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.

Concordance Analysis of the Pressure Chamber and Tubomanometer According to Estève for the Determination of Eustachian Tube Opening Pressure.

INTRODUCTION: For the diagnosis of Eustachian tube dysfunction (ETD), clinical procedures such as tympanometry, micro-otoscopy, and maneuvers according to Toynbee and Valsalva only allow an indirect assessment for the moment. With a prevalence of up to 5%, the selection of patients with ETD and its subtypes is clinically relevant. Dynamic methods of Eustachian tube function assessment include a hypo/hyperbaric pressure chamber and Estève's tubomanometer (TMM). One method of assessing ETD is the evaluation of Eustachian tube opening pressure (ETOP). MATERIAL AND METHODS: We performed a concordance analysis between pressure chamber and TMM to determine ETOP. For this purpose, we analyzed the measurements of both methods from 28 healthy subjects using Bland-Altman plots, regression according to Passing-Bablok and Lin's concordance correlations coefficient. The maximum tolerated clinical deviation of measured values was set at 10%. RESULTS: A maximum of 53 measurements of ETOP between pressure chamber and TMM were compared. Mean ETOP for TMM was 28.7 hPa, passive opening was 32 hPa, Toynbee maneuver was 28.4 hPa, and Valsalva maneuver was 54.6 hPa. Concordance analysis revealed following results: passive opening versus TMM: Bland-Altman mean difference 3.3 hPa, limits of agreement ±31.8 hPa; Passing-Bablok regression y = 0.67 x + 9.36; Lin's rccc = 0.18. Toynbee versus TMM: Bland-Altman mean difference 0.7 hPa, limits of agreement ±35.8 hPa; Passing-Bablok regression y = 0.47x + 14.03; Lin's rccc = 0.14. Valsalva versus TMM: Bland-Altman mean difference 24.2 hPa, limits of agreement ±117.5 hPa; Passing-Bablok regression y = 0.17x + 25.12; Lin's rccc = 0.18. CONCLUSION: Estève's tubomanometer and pressure chamber measurements of ETOP are not concordant. The two methods cannot be interchanged without reservation.

Combined balloon Eustachian tuboplasty/endoscopic sinus surgery for patients with chronic rhinosinusitis and Eustachian tube dysfunction.

BACKGROUND: To elucidate the role of balloon Eustachian tuboplasty (BET) in the management of chronic rhinosinusitis with obstructive Eustachian tube dysfunction (ETD), we evaluated the results of endoscopic sinus surgery (ESS) with and without BET in patients with chronic rhinosinusitis with obstructive ETD. METHODS: This randomized controlled trial conducted in a single-institution tertiary care center setting included 50 patients diagnosed with primary chronic rhinosinusitis and obstructive ETD between July 2018 and June 2022. Twenty-five patients were prospectively enrolled for combined ESS/BET. The control group (25 patients) underwent ESS alone. Outcome measurements of the Sinonasal Outcome Test 22, modified Lund-Kennedy score, Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7), and serial Eustachian tube function test results were analyzed 3 months postoperatively. RESULTS: The improvement (12.60 ± 6.50) in the ETDQ-7 score in the BET group was significantly higher than that in the control group (6.60 ± 5.58). The ratio of improvement in the ETDQ-7 score was also significantly higher in the BET than in the control group (92% vs. 68%, p = 0.034). Logistic regression analysis showed that performing BET (odds ratio [OR]: 5.41, 95% confidence interval [CI]: 1.02-28.79, p = 0.048) and a low post-modified Lund-Kennedy score (OR: 0.15, 95% CI: 0.04-0.54, p = 0.004) were significantly associated with ETDQ-7 score improvement. CONCLUSION: Combined BET/ESS could decrease otologic symptoms and improve Eustachian tube function. BET may be an appropriate adjunctive procedure for treating chronic rhinosinusitis with obstructive ETD.

Timing of First Set of Pressure Equalization Tubes in Pediatric Patients With Cleft Deformities.

OBJECTIVES: Children with cleft palates often have comorbid eustachian tube dysfunction requiring pressure equalization tubes (PETs). PETs can relieve middle ear effusions that impede hearing. Ideal PET placement timing in this population is controversial. In this study, the audiologic exam passing rates of patients with cleft palate prior to and following PET insertion were assessed. Rates for patients receiving PETs at different ages were compared. It was hypothesized that earlier PET placement may benefit patients with additional months of improved hearing. METHODS: A retrospective chart review was performed of patients with cleft palate between November 22, 2016 and November 22, 2021 at a tertiary center. Statistical analysis compared passing/normal audiologic exams in patients receiving PETs at different ages. RESULTS: A total of 348 patients had cleft palate diagnoses, received PETs, and had adequate hearing data for inclusion. Those with PETs inserted at 3 months of age or less had an increase in percent of patients passing audiologic exams following versus prior to PET insertion of 13% (1.3 times improvement). Those receiving PETs between 7- and 12-months had the largest rate of improvement (42%) (2.4 times improvement); other groups had changes in passing rates between 31% and 40%. The rate of passing audiologic exams following PET insertion was high across all groups, ranging from 66% to 81%. CONCLUSION: This is one of the first studies exploring the timing of PET placement in this population and showed that patients receiving PETs at 3 months of age or younger passed subsequent audiologic exams at similar rates relative to those receiving PETs later in life. LEVEL OF EVIDENCE: 3 Laryngoscope, 134:3391-3394, 2024.

Mid-term evaluation of the surgical management of patulous Eustachian tube dysfunction: a STROBE observational study.

INTRODUCTION: Patulous Eustachian tube (PET) is a condition affecting approximately 0.3% to 6.6% of the population, with autophony being the predominant complain. The management of PET lacks a well-defined standard in the literature as no effective medical treatments have been documented but various surgical options are available. This study aims to report mid-term outcomes following surgical management of PET. MATERIALS AND METHODS: All patients who underwent surgical intervention for PET between September 2017 and June 2022 were enrolled. Data encompassing general demographics, quality of life (GBI), and procedure-specific data were collected. RESULTS: A total of 30 PET cases (in 19 patients) underwent surgical intervention including 9 injections of hyaluronic acid, 13 fat injections, 6 endoscopic shim insertions, 1 cartilage graft, and 1 injection of hydroxy apatite. After an average follow-up of 22 ± 14 months, 16 cases (53%) achieved complete symptom relief, while 8 cases (26.6%) reported partial relief. Additionally, 11(36%) cases required multiple surgeries. No specific surgical technique demonstrated superiority. Quality of life improved in 77% of cases based on 10 out of 13 GBI collected. Recurrence of PET symptoms occurred on average 10.6 ± 9.7 months after initial surgery, with an estimated global risk of 75% at 3 years. Transient serous otitis media was observed in only 4 cases (13.3%). CONCLUSION: Surgical intervention for PET was found to be effective, achieving complete symptom relief in 53% of cases and significantly improving quality of life 2 years post-surgery. However, a substantial portion of cases necessitated one or more re-interventions. The durability of effectiveness appears to diminish over time.

Functional aspects of the Eustachian tube by means of 3D-modeling.

The extent of dysfunction of the Eustachian tube (ET) is relevant in understanding the pathogenesis of secondary otological diseases such as acute or chronic otitis media. The underlying mechanism of ET dysfunction remains poorly understood except for an apparent genesis such as a nasopharyngeal tumor or cleft palate. To better describe the ET, its functional anatomy, and the biomechanical valve mechanism and subsequent development of diagnostic and interventional tools, a three-dimensional model based on thin-layer histology was created from an ET in this study. Blackface sheep was chosen as a donor. The 3-D model was generated by the coherent alignment of the sections. It was then compared with the cone-beam computed tomography dataset of the complete embedded specimen taken before slicing. The model shows the topographic relation of the individual components, such as the bone and cartilage, the muscles and connective tissue, as well as the lining epithelium with the lumen. It indicates a limited spiraling rotation of the cartilaginous tube over its length and relevant positional relationships of the tensor and levator veli palatine muscles.

Further Research Needed to Understand Relationship Between Tubarial Glands and Eustachian Tube Dysfunction.

The pathophysiology of eustachian tube dysfunction (ETD) remains poorly characterized, and it may result in significant patient morbidity. A recent study has identified a collection of previously unidentified salivary glands in the nasopharynx that overlay the torus tubarius. While salivary gland tissue has been described in the nasopharynx, the newly discovered salivary gland tissue has been denoted tubarial glands (TGs) and theorized to be a distinct organ. The TGs have been suggested to aid in lubrication of the oropharynx and nasopharynx. However, the exact clinical significance of TGs is unknown. Given the proximity of the TG to the eustachian tube, it is possible that the TGs may be related to the development of ETD. Future studies of the TGs and related pathophysiology may improve approaches to developing future ETD treatments.

An Integrated Physical Regulation Theory and Classification of Acute Tinnitus.

Tinnitus, acute or chronic, is one of the most common and refractory disorders. Acute tinnitus is a symptom that is a warning sign when compared with chronic tinnitus. Although hearing loss initiates acute tinnitus, the relationship between hearing loss and tinnitus is far from straightforward. Other factors beyond the auditory system may play important roles in the occurrence of acute tinnitus. To address this issue, we propose an integrated regulation theory of the possible physical causes of acute tinnitus, and summarize a classification system for acute tinnitus based on this regulation theory to help guide clinical treatment.

The effect of concurrent nasal surgery on the eustachian tube function and myringoplasty outcomes.

OBJECTIVE: To investigate the Effect of concurrent nasal surgery on the eustachian tube function (ETF) and myringoplasty outcomes for the chronic perforations with coexistent nasal pathology. MATERIALS AND METHODS: We retrospectively reviewed the records of 93 patients with perforations who underwent same-day myringoplasty and nasal-septal surgery. Group A exhibited septal deviations (n = 34) and Group B inflammatory sinus disease (n = 59). Groups were compared with respect to pre- and postoperative air-bone gaps (ABGs), graft success rates and ETF (Eustachian tube score [ETS] and seven-item Eustachian Tube Dysfunction Questionnaire [ETDQ-7]) at 6 and 24 months. RESULTS: Graft success rates were 100.0% in Group A and 98.3% in Group B at 6 months postoperatively (P = 0.445). Graft success rates were 85.3% in Group A and 96.6% in Group B at 24 months postoperatively (P = 0.046), the re-perforation rate was significantly higher in Group A than in Group B (P = 0.015). Although the preoperative ETS was similar between two groups, the postoperative ETS in the Group B was significantly higher compared with Group A regardless of at postoperative 6th and 24th months. In addition, difference was significant for the patients with positive Valsalva maneuver among two groups at postoperative 24th months. Also, the improvement in the ETDQ-7 score in the B group was significantly higher than that in the A group at postoperative 6th and 24th months. CONCLUSIONS: Concurrent nasal surgery and myringoplasty is feasible. In addition, ESS improves ETF and thus long-term outcomes of myringoplasty for the chronic perforations with inflammatory sinus disease.

The Infratemporal Fossa Sign: Pilot Study of a Potential Clue to Eustachian Salpingitis.

Aural discomfort may be the result of obstructive eustachian tube (ET) dysfunction, temporomandibular joint dysfunction, or other causes. The infratemporal fossa (ITF) sign, in which a patient points to a characteristic location below the auricle, is proposed as an indicator of nonobstructive eustachian salpingitis. A preliminary study included patients with a complaint of aural discomfort who were prompted to localize symptoms using a single finger. Group 1 localized by using the ITF sign; group 2 localized deep within the external ear canal (suggesting ET dysfunction); and group 3 localized to the preauricular region (suggesting temporomandibular joint dysfunction). Findings of ET inflammation recorded during nasal endoscopy were greater in groups 1 and 2. Tympanometry and otoscopy were uniformly abnormal for group 2 and uniformly normal for groups 1 and 3. The ITF sign may help to identify eustachian salpingitis as a phenotype of ET disease characterized by symptomatic inflammation without abnormal middle ear pressure.

Gastroesophageal Reflux Disease: A Cause for Eustachian Tube Dysfunction in Obstructive Sleep Apnea.

OBJECTIVES: To explore the effect of gastroesophageal reflux disease (GERD) on Eustachian tube function in patients with obstructive sleep apnea (OSA). METHODS: This was a cross-sectional study. The patients were divided into 4 groups according to OSA and GERD: OSA+GERD group; OSA-only group; GERD-only group; and normal control group. RESULTS: There were no differences among the 4 groups regarding age, sex, smoking history, and alcohol history (all P > .05). The patients in the OSA and OSA+GERD groups had a significantly larger body mass index than those in the control and GERD-only groups (all P < .05). The proportions of patients with abnormal ETS-7 and ETD-Q results were higher in the GERD and OSA+GERD groups compared to the control group (P < .008). There were no significant differences in ETS-7 and ETD-Q between the control and the OSA-only groups (P > .008). The multivariable analysis showed that only GERD was independently associated with abnormal ETS-7 results (odds ratio = 3.090, 95% CI: 1.332-7.169, P = .009). CONCLUSION: Given the high concomitance rate in patients with OSA, GERD might be an important association factor of Eustachian tube dysfunction in patients with OSA.

Interpretation of Normal and Abnormal Tympanogram Findings in Eustachian Tube Dysfunction.

OBJECTIVE: To characterize the relationship between objective tympanogram values and patient-reported symptoms and associations with common comorbid conditions. STUDY DESIGN: Cross-sectional study with prospective data collection. SETTING: Tertiary medical center. METHODS: Patients undergoing routine audiometric evaluation between October 2018 and June 2019 were included. Participants with temporomandibular joint dysfunction, inner ear hydrops, and similar conditions were excluded. Symptoms were assessed with the 7-item Eustachian Tube Dysfunction Questionnaire. Demographics and medical comorbidities were recorded from the medical record. Analysis of tympanometric peak pressure (TPP), demographics, and comorbidities was performed to determine associations with clinically significant eustachian tube dysfunction (ETD) symptoms. RESULTS: A total of 250 patients were included with similar demographics: 101 (40.4%) in the asymptomatic group and 149 (59.6%) in the symptomatic group. The median (interquartile range) TPP was -10 (20) daPa and -25 (100) daPa in the asymptomatic and symptomatic groups, respectively. A diagnosis of rhinitis was more likely to be associated with significant ETD symptoms (adjusted odds ratio, 2.61; 95% CI, 1.23-5.63). A subgroup analysis revealed that symptomatic patients with normal TPP values were negatively skewed as compared with asymptomatic patients. This symptomatic group had a higher prevalence of rhinitis and chronic rhinosinusitis than the asymptomatic group. CONCLUSION: Patients with symptoms of ETD may have a TPP within a range typically considered normal per conventional standards. This suggests that the currently accepted interpretation of tympanometry findings may be insensitive for the diagnosis of less severe cases of ETD.

PREVALENCE OF HEARING SYMPTOMS RELATED TO PATULOUS EUSTACHIAN TUBE AFTER BARIATRIC SURGERY.

BACKGROUND: Rapid and severe weight loss can result in the reduction of the ear tube lining fat tissue and it becomes patent, leading to symptoms such as autophony, aural fullness and tinnitus. Patients after bariatric surgery have, in theory, a predisposition to the development of such alteration. AIM: To evaluate the presence of patent tuba-related complaints in patients undergoing bariatric surgery, correlating with weight and body mass index (BMI) values, as well as demographic data. METHODS: Cross-sectional study composed of the evaluation of patients undergoing bariatric surgery through a standardized questionnaire about the presence of symptoms compatible with ear tube patency. RESULTS: Eighty patients were evaluated, 77 female and three males. The main comorbidity was systemic arterial hypertension (37.5%). Fifteen (18.75%) presented symptoms compatible with patent auditory/Eustachian tube - aural fullness and autophony - postoperatively. In symptomatic individuals the initial weight was 112 kg on average and the preoperative BMI was 45 kg/m², while in asymptomatic individuals the weight was 117 kg and BMI 47 kg/m². There was statistical significance in the comparison between individuals with and without symptoms in the variables of initial weight (p=0.00000), current weight (p=0.00029), preoperative BMI (p=0.00219) and postoperative BMI (p=0.00148). CONCLUSION: The presence of symptoms compatible with patent auditory/Eustachian tube was 18.75% of the patients submitted to bariatric surgery in the evaluated sample. Both preoperative weight and BMI were lower in symptomatic patients when compared with the asymptomatic group.