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PURPOSE: Safety and efficacy of SENS-401, a serotonin type 3 (5-HT3) receptor antagonist and calcineurin inhibitor, in patients with acute sudden sensorineural hearing loss (SSNHL). METHODS: Multicentre randomized, double blind, placebo-controlled trial enrolled adult subjects with sudden sensorineural hearing loss (SSNHL) or unilateral/bilateral acute acoustic trauma leading to SSNHL within 96 h of disease onset. Subjects were randomly assigned to one of the three oral dose groups: 29 mg, 43.5 mg or placebo given twice daily for 28 days. The primary endpoint was the change from baseline in Pure Tone Average (PTA) in the affected ear to the end of treatment visit (day 28). Subjects were further followed up 8 weeks after the end of the treatment period (day 84). RESULTS: A total of 115 subjects were randomized. SENS-401 was well tolerated. Although the primary efficacy endpoint was not met at day 28, post-hoc analyses revealed clinically significant and meaningful efficacy outcomes with SENS-401 when compared to placebo in a substantial group of participants diagnosed with idiopathic SSNHL and who had received corticosteroid treatment. Notable improvements were observed in the PTA change from baseline, the complete hearing recovery rate, and the Word Recognition Score (WRS), particularly at day 84. The responder rate consistently favored treated subjects over those who received the placebo. CONCLUSION: While the primary endpoint was not achieved at the end of the treatment period, the study revealed consistently positive efficacy results of clinical relevance in patients with idiopathic SSNHL who received SENS-401, particularly in the 8-weeks follow-up phase after the completion of the treatment.

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PURPOSE: To explore the efficacy of diagnostic tests in accurately reclassifying patients initially diagnosed with probable Meniere's disease (MD) into either definite or non-MD categories. MATERIALS AND METHODS: A retrospective cohort study was conducted at a neurotology clinic between 1/2016 and 5/2022. Patients underwent a battery of tests, from which sensitivity, specificity, positive and negative predictive values, as well as positive and negative likelihood ratios, were calculated. Additionally, prediction nomograms were developed. RESULTS: Of the 69 patients, 25 (36.2 %) were initially classified as definite MD, 21 (30.4 %), probable MD, and 23 (33.4 %) non-MD. The mean follow-up was 3.5 years. The sensitivity of electrocochleography (ECochG) was the highest (92 %), with a negative likelihood ratio of 15 %. Magnetic resonance imaging (MRI) with MD-protocol had the highest specificity (100 %), with a positive likelihood ratio of 100 %. Videonystagmography, video head impulse test, and cervical vestibular-evoked myogenic potentials, had lower sensitivity and specificity. We were able to reclassify 18 (86 %) patients with probable MD: 12 (57 %) were diagnosed with definite MD, and 6 (29 %) were diagnosed with non-MD, consistent with their clinical course. CONCLUSIONS: The combination of ECochG and MRI with MD-protocol provides the most reliable approach to reclassify patients with Probable MD, ensuring a precise and accurate diagnosis. Vestibular tests express the functional status of the labyrinth and may not be reliable. Our findings provide valuable insights into clinical decision-making for patients with Probable MD and raise the consideration of additional diagnostic tests as supplementary to the existing clinical-only diagnosis criteria.

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INTRODUCTION: Acute mastoiditis (AM) can rapidly become life-threatening with various intracranial complications. The standard care includes antibiotics, mastoidectomy, and drainage. Reports show varying preferences for conservative and surgical treatments, with a more conservative approach gaining popularity. In this study we aim to evaluate the presenting symptoms, management and outcomes of patients presenting with intracranial complications secondary to acute mastoiditis. METHODS: Retrospective review for all children admitted for acute mastoiditis for 12 years period (January 2010-December 2021). Children who had mastoiditis associated with intracranial complications were included in the study. STROBE guidelines were followed in this study. RESULTS: 23 patients were diagnosed with acute mastoiditis with intracranial complications. The mean age was 2.1 years. The most common presenting sign was fever, followed by otalgia. The most common pathogens were Fusobacterium necrophorum and Streptococcus pneumoniae. The most common intracranial complication was sinus vein thrombosis (SVT) affecting 13 patients. Eventually, 10 patients underwent cortical mastoidectomy during 1-6 days upon admission, with an average of 3.2 days. During the follow-up period patients were monitored for clinical progression. Patients who did not show clinical improvement such as persistent fever, worsening symptoms, or the presence of neurological symptoms were treated surgically. The length of stay was an average of 15.5 days overall, with no significantly longer hospital stay in patients who were treated surgically compared to patients who were treated conservatively (17.1 days vs. 14.2 days, P = .26). CONCLUSION: Intracranial complications of acute mastoiditis remain a significant challenge. Selected patients with intracranial complications can be treated conservatively with close monitoring, without increasing the risk of immediate or long-term complications. Initial antimicrobial treatment should cover anaerobic bacteria, as it correlates with severe complications.

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INTRODUCTION: The acoustic reflex is the active response of the middle ear to loud sounds, altering the mechanical transfer function of the acoustic energy into the inner ear. Our goal was to observe the effect of the acoustic reflex on the tympanic membrane by identifying a significant nonlinear increase in membrane oscillations. METHODS: By using interferometric spectrally encoded endoscopy, we record the membrane oscillations over time in response to a loud, 200-ms-long acoustic stimulus. RESULTS: A gradual reflex activation is measured between approximately 40 and 100 ms, manifested as a linear 42% increase in the umbo oscillation amplitude. CONCLUSION: The measured oscillations correlate well with those expected from a mechanical model of a damped harmonic oscillator, and the results of this work demonstrate the potential of interferometric spectrally encoded endoscopy to observe unique dynamical processes in the tympanic membrane and in the middle ear.

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OBJECTIVE: To compare the outcomes of different surgical approaches to petrous apex cholesterol granulomas (PACG). DATA SOURCES: PubMed, Embase, Google Scholar, Cochrane, and Web of Science. REVIEW METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses-Network Meta-analyses guidelines, databases were searched from inception to November 31, 2022. Studies comparing two or more approaches were included. Reviews and population studies were excluded. The main outcome measures were the resolution of symptoms, serviceable hearing, complication, and revision rates. RESULTS: The search yielded 2132 studies. After applying inclusion and exclusion criteria, 15 studies remained, consisting of 214 patients treated with lateral approaches (n = 182) or anterior endonasal approaches (n = 32). The efficacy of lateral and anterior endonasal approaches in achieving symptom resolution was comparable (73% vs. 68%, p = 0.5). Both exhibited similar rates of complications (33% vs. 37%, p = 0.3), albeit with distinct profiles. Lateral approaches were associated with higher rates of facial palsy and sensorineural hearing loss (44% vs. 18%, p = 0.03). Anterior endonasal approaches demonstrated higher rates of epistaxis and cerebrospinal fluid leak (15% vs. 1%, p = 0.001). Anterior endonasal approaches exhibited lower revision rates (OR: 0.35, 95% CI: 0.14-0.88). The placement of a stent in both approaches was associated with higher symptom resolution (OR: 5.12, 95% CI: 1.05-9.97) and lower revision rates (OR: 0.71, 95% CI: 0.33-0.92). CONCLUSIONS: Anterior endonasal approaches yield lower revision rates compared to lateral approaches for PACG. Both approaches demonstrate similar effectiveness in symptom resolution and comparable rates of complications, with distinct profiles. Facial nerve and hearing status are important factors that should be addressed when selecting the approach. Stenting is beneficial. LEVEL OF EVIDENCE: NA Laryngoscope, 134:1540-1550, 2024.

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OBJECTIVES: The purpose of this study was to assess the effectiveness and safety of xylitol nasal spray as a prophylactic treatment for children with recurrent acute otitis media (AOM). METHODS: This is a prospective pilot study of children aged 1-4 years, diagnosed with recurrent AOM (at least three episodes in the three months before recruitment) between December 1, 2019 and January 31, 2023. Children were treated with nasal xylitol spray 2-3 times daily for 3 months. The number of AOM episodes and treatments administered were compared within 3-month intervals: before recruitment, during xylitol use, and during the three subsequent months. RESULTS: Of 68 children enrolled, 66 (97%) completed the follow-up, until July 2023. Thirty-eight (58%) were males. Sixty-three children (95%) were 12-24-months old. The mean number of AOM episodes during xylitol use, 1.06 (95% confidence interval [CI]: 0.73-1.39), was lower than in the 3-month previous interval, 4.12 (95% CI: 3.89-4.40), p < 0.001; and similar to that in the subsequent 3-month interval, 0.79 (95% CI: 0.49-1.08), p = 0.082. A similar pattern was observed in an analysis of the number of AOM episodes per patient month. The data were similar during spring and summer months as during autumn and winter months. Across the consecutive three-month intervals, decreases were observed in the mean number of AOM episodes treated with systemic antibiotics (3.35, 0.65, and 0.41), p < 0.001; and with topical antibiotics (1.38, 0.55, and 0.32), p < 0.001. No major side effects were recorded. CONCLUSIONS: The findings support the effectiveness and safety of nasal xylitol spray, for preventing recurrent AOM in children aged 1-4 years.

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INTRODUCTION: Otosclerosis is the primary cause of conductive hearing loss with normal otoscopy. As the condition worsens, certain patients may develop a sensorineural component. Patients with successful surgeries may still need hearing aids, which creates a dilemma for health professionals as there are insufficient data to make informed decisions. This study investigated the influence of the surgeon's proficiency level, individual patient factors (e.g., age at the time of intervention and survival rates), and surgery costs on the cost-effectiveness of stapes surgery. METHODS: We performed a cost-effectiveness analysis using an adapted Markov model incorporating annual all-cause mortalities. In addition, we introduced sensitivity analyses to address the effects of surgical expertise on adults with bilateral conductive hearing loss due to otosclerosis. A model was developed based on a decision tree with treatment options and complication scenarios for otosclerosis patients undergoing stapes surgery or receiving hearing aids. Annual all-cause mortality was considered. A sensitivity analysis was performed assigned to different training levels ("experts" and "less experienced") to simulate the effects of surgical experience on the cost-effectiveness of surgical outcomes. Successful surgery was defined as closing of the air-bone gap to 10 dB or less. Based on published data, "experts" were simulated with a 93.7% success rate, and "less experienced" were manufactured with a 68.9% success rate. RESULTS: Stapes surgery provides improved quality of life (QoL) compared to hearing aids with lower cumulative costs up to 87 years of age in the case of "expert" surgeons and up to 78 years of age, when performed by "less experienced" surgeons. CONCLUSIONS: Primary stapes surgery is highly cost-effective and delivers improved QoL compared to hearing aids with lower cumulative costs. Additionally, undergoing stapes surgical training remains highly cost-effective.

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OBJECTIVES: To assess the efficacy of avoiding mastoid pressure dressing (MPD) on children as a means of preventing discomfort and post-operative pain. DESIGN: A retrospective controlled study. SETTING: All operations were carried out by experienced surgeons using standard techniques, whose custom, not the gravity of any individual case, dictated the use of MPD. PARTICIPANTS: Children who underwent mastoidectomy for inflammatory middle ear diseases at a tertiary centre from 2010 to 2021. MAIN OUTCOME MEASURES: Wound-related complications and Visual Analogue Scale (VAS) pain scores at discharge were compared between children who had an MPD applied following surgery and those who did not. RESULTS: One hundred thirty-five cases were included. The demographic characteristics of the patients and surgical techniques employed were similar for both groups. There were 91 patients in the MPD group and 44 in the non-mastoid dressing (NMPD) group. In the MPD group, five patients developed minor wound dehiscence, eight experienced surgical site infections (SSI), and one patient developed a keloid. In the NMPD group, one patient had an SSI, one patient suffered from a keloid scar, wound dehiscence was observed in one patient, and another one had a local hematoma. Therefore, there were no differences between the groups in relation to post-operative complications (p = .32). Despite these similitudes, the NMPD patients suffered less post-operative pain, as measured by the VAS (p = .02). CONCLUSION: This study shows that no significant benefit is derived from using an MPD after mastoidectomy in children. Surgeons should adhere to principles of appropriate haemostasis and wound closure to prevent post-operative wound complications. Our study supports the abandonment of routine MPD in children following mastoidectomy.

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Importance: Septorhinoplasties are performed for functional, aesthetic, or a combination of these indications. As a nonvital intervention, cost-effectiveness may be questioned. Objective: To determine the cost-effectiveness of septorhinoplasty. Design and Setting: The literature was reviewed for revision rates (RRs) and health utility values (HUVs) for both septorhinoplasty and revision septorhinoplasty. Age-specific mortality rates and life expectancies were used. Costs were gathered from international settings and analyzed in an adapted Markov model. Intervention: Septorhinoplasty versus no intervention. Main Outcomes and Measures: Cost-efficiency was calculated for different willingness-to-pay thresholds in a probabilistic sensitivity analysis. The effect of different parameters (costs, RRs, HUVs, age, gender) were reviewed and addressed in a sensitivity analysis for an incremental cost-effectiveness ratio (ICER) willingness-to-pay threshold of $50,000/quality-adjusted life year (QALY). Results: The ICER for septorhinoplasty for a 40-year-old woman ranges from $1216 to $3509/QALY (depending on the country) in comparison with no intervention. Septorhinoplasty is cost-effective in 98.8% (for a $50,000/QALY threshold). The sensitivity analysis showed high robustness of the cost-effectiveness for various scenarios. Conclusions and Relevance: Septorhinoplasty is a highly cost-effective treatment.

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OBJECTIVE AND INTERVENTION: To compare the efficacy of the inlay, composite chondroperichondrial clip (triple-C) tympanoplasty with conventional underlay cartilage island tympanoplasty, and to evaluate its efficacy in treating large, marginal perforations. STUDY DESIGN: The study involved 183 patients that were selected from a retrospective chart review of tympanoplasties performed at our center from March 2016 to June 2018. SETTING: A tertiary referral center hospital. PATIENTS: 65 patients underwent inlay, triple-C cartilage tympanoplasty (inlay group) and 118 underwent underlay cartilage island tympanoplasty (underlay group). MAIN OUTCOME MEASURES: Postoperative anatomical success rate, surgical time, hearing outcomes, and complications were analyzed. Focused analysis was performed on large or marginal perforations. RESULTS: Both groups exhibited similar characteristics in demographic distribution, general health status, preoperative anatomical and hearing disabilities. Excellent results were achieved in both groups. Re-perforation occurred for 9.2% of the inlay group and 7.6% of the underlay group (p = 0.71). Hearing improvement was significant in both groups. Within the separate groups, 36% of underlay patients and 60% of inlay patients improved to achieve closure of the air-bone gap (ABG) to less than 10 dB (p = 0.1). In large or marginal perforations, both groups performed similarly. No significant complications were seen in this cohort. Nevertheless, a significant reduction in surgical time was observed in the inlay group (38 min. vs 58 min.; p = 0.0004). CONCLUSION: Inlay triple-C tympanoplasty is comparable to conventional underlay cartilage island tympanoplasty in both anatomical and audiological success rates, even for large, marginal perforations. Due to its shorter operation time, inlay triple-C tympanoplasty should be considered a good surgical option for all tympanic membrane perforations.

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