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Purpose: This multicentric, retrospective study provides safety and performance data of the MED-EL total ossicular replacement prostheses (TORP)., Methods: Patients underwent tympanoplasty with mXACT Total Prosthesis Center, mXACT Total Prosthesis Offcenter or mXACT PRO Total Prosthesis. The clinical data were retrospectively analyzed. Follow-up examination included access to the medical record (for adverse events) of the patients, ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA 4 ). The post-operative PTA 4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined., Results: 103 patients were implanted with a TORP. 102 (88 adults, 14 children; 37 CHL, 64 MHL, 1 not specified) patients were analyzed for safety and 92 (79 adults, 13 children) patients for performance of the prostheses. ADVERSE EVENTS RESULTS (N = 102): In 1 patient (child, mXACT Total Prosthesis Offcenter) a prosthesis dislocation was reported, which lead to a revision surgery. No prosthesis extrusion or migration was reported. AUDIOLOGICAL RESULTS (N = 92): 49 (53.3%) of the 92 patients had a PTA 4 ABG of ≤ 20 dB and therefore a successful rehabilitation. The mean post-operative PTA 4 ABG of all 92 patients was 21.0 ± 9.7 dB. The first endpoint, improvement in post-operative PTA 4 ABG of ≤ 20 dB by ≥ 25% of the patients was achieved. The individual Δ BC PTA 4 (post-operative minus pre-operative BC PTA 4 ) thresholds were stable (within ± 5 dB HL) in 91 (98.9%) patients. 1 patient had a BC PTA 4 deterioration of 11.3 dB HL., Conclusion: The MED-EL TORPs are safe and effective for middle ear reconstruction. Trial registration number NCT05565339, September 09, 2022, retrospectively registered., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: The aim of the presented study was to compare the audiological benefit achieved in cochlear implant (CI) patients who, in principle, could still have been treated with an active middle ear implant (AMEI) with a group of AMEI users., Methods: Results of 20 CI patients with a pure-tone average (PTA) of 70 dB HL prior to surgery were compared with a group of 12 subjects treated with a Vibrant Soundbridge (VSB). Pre-surgical comparison included PTA for air conduction and bone conduction, maximum speech recognition score for monosyllabic words (WRSmax), and aided monosyllabic word recognition at 65 dB SPL. One year after surgery, aided monosyllabic speech recognition score at 65 dB SPL was compared., Results: Mean PTA for air conduction in the VSB group was significantly lower than in the CI group (4.8 dB, Z =  - 2.011, p < 0.05). Mean PTA for bone conduction in the VSB group was also significantly lower than in the CI group (23.4 dB, Z =  - 4.673, p < 0.001). WRSmax in the VSB group was significantly better than in the CI group (40.7%, Z =  - 3.705, p < 0.001). One year after treatment, there was no significant difference in aided speech perception in quiet between both subject groups., Conclusion: Comparison of the two methods showed equivalent results for both treatments in subjects with a borderline indication. Not only pure-tone audiometry results but, particularly, speech perception scores pre-surgery should be taken into account in preoperative counseling., (© 2024. The Author(s).)

Purpose: To evaluate the effect of piston diameter in patients undergoing primary stapes surgery on audiometric results and postoperative complications., Methods: A retrospective single-center cohort study was performed. Adult patients who underwent primary stapes surgery between January 2013 and April 2022 and received a 0.4-mm-diameter piston or a 0.6-mm-diameter piston were included. The primary and secondary outcomes were pre- and postoperative pure-tone audiometry, pre- and postoperative speech audiometry, postoperative complications, intraoperative anatomical difficulties, and the need for revision stapes surgery. The pure-tone audiometry included air conduction, bone conduction, and air-bone gap averaged over 0.5, 1, 2 and 3 kHz., Results: In total, 280 otosclerosis patients who underwent 321 primary stapes surgeries were included. The audiometric outcomes were significantly better in the 0.6 mm group compared to the 0.4 mm group in terms of gain in air conduction (median = 24 and 20 dB, respectively), postoperative air-bone gap (median = 7.5 and 9.4 dB, respectively), gain in air-bone gap (median = 20.0 and 18.1 dB, respectively), air-bone gap closure to 10 dB or less (75% and 59%, respectively) and 100% speech reception (median = 75 and 80 dB, respectively). We found no statistically significant difference in postoperative dizziness, postoperative complications and the need for revision stapes surgery between the 0.4 and 0.6 mm group. The incidence of anatomical difficulties was higher in the 0.4 mm group., Conclusion: The use of a 0.6-mm-diameter piston during stapes surgery seems to provide better audiometric results compared to a 0.4-mm-diameter piston, and should be the preferred piston size in otosclerosis surgery. We found no statistically significant difference in postoperative complications between the 0.4- and 0.6-mm-diameter piston. Based on the results, we recommend always using a 0.6-mm-diameter piston during primary stapes surgery unless anatomical difficulties do not allow it., (© 2024. The Author(s).)

Background: The objective-based methods for intraoperative monitoring have been suggested to assess the coupling and the outcomes of Vibrant Soundbridge (VSB). Although several techniques were proposed, they have not been widely adopted due to their complexity and invasiveness., Purpose: This study aimed to investigate the accuracy of a new coupling quality index using an intraoperative ABR threshold via AcoustiAP and its correlation with the perioperative measures., Methods: This is a prospective study conducted at a tertiary center. The medical records were retrieved for all patients who underwent VSB implantation and had an intraoperative objective assessment for the coupling efficiency. AcoustiAP was used to evaluate the intraoperative ABR thresholds, which were assessed directly after the floating mass transducer (FMT) placement using acoustic CE-Chirp signals. The Vibrogram was used for the postoperative audiological evaluation. A new coupling quality index was calculated based on the intraoperative ABR thresholds., Results: Ten patients were eligible for the present study. The ABR thresholds for good coupling ranged from 35 to 60 dBnHL. The loose coupling thresholds ranged considerably from 40 to 100 dBnHL. Overall, the median intraoperative ABR threshold at good coupling was 42.5 (40-60) dBnHL and 60 (40-100) dBnHL at loose coupling. The analysis showed that there was a significant change in the coupling quality index at the good and loose coupling points (24.3 ± 14 vs 38.8 ± 18.2, respectively, p < 0.001). At a cut-off value of 22.6 dB, the coupling quality index had a sensitivity of 70%  and specificity of 90% for discriminating good and loose coupling., Conclusion: This study provides evidence for the utility of intraoperative ABR measurements in predicting the coupling efficiency in patients with VSB. Our results showed that the coupling quality index had an acceptable accuracy in discriminating between good and poor coupling, which can help clinicians optimize the fitting process for individuals and may ultimately lead to improved patient outcomes., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: This multicentric, retrospective study aimed to analyze the short-term safety and effectiveness of the mCLIP Partial Prosthesis., Methods: Patients underwent tympanoplasty with implantation of a mCLIP Partial Prosthesis. Follow-up examination included ear microscopy and pure-tone audiometry to determine the post-operative pure tone average of the frequencies 0.5, 1, 2 and 3 kHz (PTA 4 ). The post-operative PTA 4 air bone gap (ABG) was used to evaluate the audiological outcome. A post-operative minimum and maximum follow-up period was not defined. Thus, the follow-up times of each study center were different, which resulted in different follow-up times for the audiological analysis and for adverse events (AE)., Results: 72 (66 adults, 6 children) patients were implanted with the mCLIP Partial Prosthesis. 68 (62 adults, 6 children) patients underwent audiological examination; all 72 patients were examined for adverse events. All patients (N = 68): 72.1% of the patients showed a PTA 4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA 4 thresholds were stable in 67 patients. The mean post-operative follow-up time was 78 ± 46 days. Children (N = 6): 5 out of 6 children showed a PTA 4 ABG of ≤ 20 dB. None of the children reported a BC PTA 4 deterioration of > 10 dB HL after the implantation. The mean post-operative follow-up time was 101 ± 45 days. Adverse events (all patients, N = 72): 15 (14 adults, 1 child) patients had AEs (27 AEs and 2 Follow-Ups). The mean post-operative follow-up time was 375 days., Conclusion: Clinical data show satisfactory audiological parameters after implantation of the mCLIP Partial Prosthesis. The prosthesis is safe and effective for implantation in children and adults., Trial Registration Number: NCT05565339, 09 September 2022, retrospectively registered., (© 2023. The Author(s).)

Purpose: In primary cholesteatoma patients, incus destruction with an intact and mobile stapes is a frequent finding. Different techniques have been described to restore the ossicular chain, including incus interposition, stapes augmentation and type III tympanoplasty. Controversy about postoperative hearing results in open versus closed surgical techniques exist., Methods: We performed a retrospective analysis of clinical, surgical and audiometric data of patients with primary cholesteatoma surgery operated between 2010 and 2020, and a mobile stapes and one-stage ossicular reconstruction. Pre- and post-operative audiograms were compared for the different surgical groups, mainly focusing on postoperative air-bone gap. Mastoid pneumatization and ventilation was also considered., Results: The mean postoperative air-bone gap (0.5-4 kHz) of the 126 included patients was 20 dB. Hearing after type III tympanoplasty (26 dB) was worse than incus interposition (19 dB) and stapes augmentation (20 dB). Hearing after an open (23 dB) versus closed (19 dB) surgical technique was significantly different. No improvement in air-bone gap was observed for the higher frequencies., Conclusion: A residual postoperative air-bone gap should be considered after primary cholesteatoma surgery with intact and mobile stapes. Incus interposition in closed cavity operation is the optimal situation, but open cavity surgery should not be avoided because of hearing. Extent of the disease is prioritized and poorer ventilation before and after surgery may affect postoperative hearing., (© 2023. The Author(s).)

Purpose: The Vibrant Soundbridge (VSB) is an established active-middle-ear-implant for patients with moderate-to-profound hearing-loss. This surgery is referred to as "Vibroplasty". Sufficient transfer of the VSB's floating-mass-transducers (FMT) energy to the inner ear is a crucial factor influencing the coupling-quality (CQ). However, assessing CQ is hamper by two issues: the method of CQ-assessment itself and the method of FMT-fixation during Vibroplasty., Methods: This prospective study explored the influence of intraoperative auditory-brainstem-response (+ ABR) measurements and various fixation methods on postoperative CQ after Vibroplasty as compared to matched-patients after Vibroplasty without intraoperative ABR (-ABR). Propensity-score-matching was performed based on preoperative bone-conduction-pure-tone-average-3 (BC-PTA3) at 1-, 2- and 4 kHz. Primary outcome parameters were postoperative CQ-PTA3, intraoperative ABR threshold for various fixation methods and postoperative BC-PTA3., Results: A total of 28 patients were included, of which 14 were + ABR. Preoperative BC-PTA3, sex, age, and number of previous surgeries did not differ significantly between groups (all p > 0.301). Mean postoperative CQ-PTA3 was significantly better for + ABR (1.8 vs. 12.3 dB-HL; p = 0.006). Mean intraoperative ABR threshold was superior for cartilage-counter-bearing and cartilage-housing compared to additional fixation with injectable-platelet-rich- fibrin (53 vs. 56 & 57 dB-HL, respectively; p = 0.04; η 2  = 0.33). Mean postoperative BC-PTA3 did not significantly differ between patients (41.4 vs. 41.8 dB-HL; p = 0.77). A total of 7% of the patients required intraoperative readjustment of the FMT based on unsatisfactory intraoperative ABR threshold., Conclusion: Intraoperative ABR measurement resulted in significantly better postoperative CQ. Cartilage-counter-bearing and cartilage-housing were observed to have superior CQ. A total of 7% of the patients could be spared revision-Vibroplasty due to intraoperative ABR measurement., (© 2023. The Author(s).)

Purpose: The aim of this study was to evaluate the long-term effectiveness and acceptance of the active middle ear implant system Vibrant Soundbridge (VSB ® , MED-EL, Austria) in patients with aural atresia or aplasia (children and adults)., Methods: Data from 51 patients (mean age 13.9 ± 11.3 years), 42 (79.2%) children and adolescents, and 11 (20.8%) adults) who received a VSB implant between 2009 and 2019 at the Department of Otolaryngology at LMU Clinic Großhadern, Munich were included in the study. Pure-tone audiometry, speech recognition in a quiet environment and in a noisy environment were performed preoperatively, during the first fitting of the audio processor, after 1-3 years, after 3-5 years, and after 5 years (if possible). The follow-up period ranged from 11 to 157 months with a mean of 58.6 months (4.8 years). Furthermore, the benefit of the VSB was evaluated by self-assessment questionnaires (Speech, Spatial, and Qualities of Hearing Scale, respectively, for parents)., Results: Significant improvements were observed in hearing and speech comprehension immediately after the initial fitting of the VSB system (mean hearing gain 38.4 ± 9.4 dB HL) and at follow-up intervals (1-3, 3-5 and after 5 years) for children and adults (p < 0.01). The values remained stable over the long-term, indicating a sustained functional gain from the VSB (mean hearing gain 38.9 ± 9.2 dB HL). The results of the self-assessments affirm the positive influence on hearing and speech comprehension with the VSB. With the VSB, there was an improvement of 41.3 ± 13.7% in the Freiburg monosyllable test., Conclusion: These results (a stable hearing gain over the long term, a good tolerance of the implant and an improvement in quality of life) affirm the recommendation for using the active middle ear implant VSB as early as permitted for aural atresia and aplasia patients. This study represents the audiometric results with the (to date) largest collective of aural atresia patients and with a long follow-up period., (© 2023. The Author(s).)

Objective: To analyze and compare the early and late post-operative results of glass ionomer bone cement (GIBC) used in ossiculoplasty., Methods: The pre-operative, early post-operative (3 months) and late post-operative (> 2 years) audiometric findings, namely the pure-tone average (PTA), bone conduction threshold (BCT) and air-bone gap (ABG) of 40 patients who underwent GIBC ossiculoplasty for different etiologies were analyzed. Early and late results were compared. Also, the patients were grouped in terms of prognostic factors and applied ossiculoplasty techniques, and the results were compared between the groups., Results: There were statistically significant improvements in the pure-tone average and air-bone gap of the patients in the early post-operative period (PTA from 59.60 ± 15.95 to 40.37 ± 17.83 and ABG from 37.12 ± 11.18 to 19.78 ± 10.41, p < 0.001 for both). There were no statistically significant changes in any of the audiometric parameters in the late post-operative period (PTA from 40.37 ± 17.83 to 39.79 ± 17.91, ABG from 19.78 ± 10.41 to 19.32 ± 9.60, BCT from 17.99 ± 12.71 to 18.31 ± 13.99, p > 0.05 for all). Presence of tympanosclerosis was found to be the only prognostic factor to affect the outcome., Conclusion: GIBC is a safe and reliable material for ossiculoplasty, which maintains its ability to conduct sound in the long-term follow-up., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: This study aimed to propose a radiological classification of the incudo-stapedial angle by preoperative high-resolution computed tomography (HRCT) images and to highlight its importance for predicting the use of reversal-steps stapedotomy (RSS) rather than the traditional non-reversal technique., Methods: We included 83 candidates for stapedotomy operation. Two physicians measured the radiological incudo-stapedial joint angle in the preoperative HRCT. According to this measurement, the radiological incudo-stapedial joint was classified into three types: obtuse, right, and acute. In addition, this radiological classification was correlated with the intraoperative use of the stapedotomy technique, either reversal or non-reversal., Results: The RSS technique was used in forty-two (97.7%) cases with an obtuse angle and twenty-six (89.7%) with a right angle. At the same time, the traditional non-reversal technique was used in all patients with an acute angle. The three groups differed significantly regarding the method used for stapedotomy (P value < 0.001). Moreover, Spearman's correlation coefficient revealed a significant correlation between the used technique and the radiological type of the incudo-stapedial angle (P value < 0.001)., Conclusions: This prospective study proposed a preoperative radiological classification of the incudo-stapedial angle. This classification was significantly correlated with the type of stapedotomy technique. The RSS technique was feasible in most cases with an obtuse and right radiological incudo-stapedial angle. In contrast, the non-reversal method was used in all patients with an acute radiological incudo-stapedial angle. This radiological classification could predict the choice for the stapedotomy technique with an accuracy of 95.18%, a sensitivity of 73.33%, and a specificity of 100%., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: To describe the surgical procedure of exclusive endoscopic ossiculoplasty (EEO) with autologous grafts and evaluate audiological results, focusing on the advantages or drawbacks compared to the corresponding microscopic technique., Methods: A retrospective review of consecutive adult and pediatric patients affected by chronic otitis media (COM) with or without cholesteatoma who underwent EEO was conducted. Only autologous ossiculoplasty was included in the study. The procedure was performed by experienced surgeons of our institution between November 2014 and September 2019. Hearing outcomes were evaluated using postoperative air-bone gap (ABG) and success rates in different subgroups of patients and different types of ossiculoplasty (OPL) were analyzed. Our results were finally compared with the existing literature regarding both microscopic and endoscopic ossicular chain reconstruction., Results: In total, 74 endoscopic ossicular chain repair procedures performed within the study period met the inclusion criteria. Of these, 21 were pediatric patients (28%) and 53 were adults (72%). Surgical reconstruction procedures included 43 partial ossicular reconstructions (POR) and 31 total ossicular reconstructions (TOR). The postoperative ABG improved significantly compared to preoperative measurements, and the mean ABG closure was 7.85 dB HL (p = 0.00064). No statistically significant differences in audiological outcomes between TOR/POR techniques and pediatric/adult groups were found in our study cohort, with p values of 0.10 and 0.88, respectively., Conclusions: At present, EEO can be considered a valid surgical option for re-establishing a functioning ossicular chain with acceptable hearing restoration in children and adults. Further reports in wider case series are required to confirm these results., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Due to smaller bone thickness, young children with conductive or mixed hearing loss or single-sided deafness were previously most commonly treated with a percutaneous osseointegrated bone-anchored hearing aid (BAHA) or an active middle-ear implant. While the BAHA increases the risk of implant infections, skin infection, overgrowth of the screw or involvement of the implant in head trauma, middle-ear implant surgery involves manipulation of the ossicles with possible risk of surgical trauma. These complications can be omitted with transcutaneous bone conduction implant systems like the MED-EL Bonebridge system. The purpose of this study was to analyze whether the second generation of the Bonebridge (BCI 602) that features a decreased implant thickness with a reduced surgical drilling depth can be implanted safely in young children with good postoperative hearing performance., Methods: In this study, 14 patients under 12 years were implanted with the second generation of the Bonebridge. Preoperative workup comprised a CT scan, an MRI scan, pure tone audiometry, or alternatively a BERA (bone conduction, air conduction). Since children under 12 years often have a lower bone thickness, the CT was performed to determine the suitability of the temporal bone for optimal implant placement using the Otoplan software., Results: All patients (including three under the age of five) were successfully implanted and showed a good postoperative hearing performance., Conclusion: With adequate preoperative workup, this device can be safely implanted in children and even children under 5 years of age and allows for an extension of indication criteria toward younger children., (© 2023. The Author(s).)

Objective: To review hearing and surgical outcomes after reconstructive middle ear surgery in class 4 congenital middle ear anomalies (CMEA), e.g., patients with oval- or round window atresia of dysplasia., Data Sources: Pubmed/Medline, Embase and Cochrane library., Review Methods: Articles containing data on hearing outcomes and complications after reconstructive ear surgery in class 4 anomalies were analyzed and critically appraised. The following data were included and reviewed: patient demographics, audiometric testing, surgical techniques, complications, revision surgeries and their outcomes. Risk of bias was determined, and GRADE certainty of evidence was assessed. Primary outcomes were postoperative air conduction thresholds (AC), change in AC, and success rates (closure of the ABG to within 20 dB), the occurrence of complications (most importantly sensorineural hearing loss) and the long-term stability of hearing results (> 6-month follow-up) and occurrence of recurrence of preoperative hearing loss., Results: Success rates varied from 12.5 to 75% at long-term follow-up with larger cohorts reporting success rates around 50%, mean postoperative gain in AC varied from 4.7 to 30 dB and - 8.6 to 23.6 dB at, respectively, short- and long-term follow-up. No postoperative change in hearing occurred in 0-33.3% of ears, and recurrence of hearing loss occurred in 0-66.7% of ears. SNHL occurred in a total of seven ears across all studies of which three experienced complete hearing loss., Conclusion: Reconstructive surgery can be an effective treatment option which should be considered in patients with very favorable baseline parameters, while also considering the substantial risk of recurrence of hearing loss, the possibility of unchanged hearing despite surgery and the rare occurrence of SNHL., Level of Evidence: 2c., (© 2023. The Author(s).)

Purpose: The objectives of the present clinical trial are to describe our surgical technique for advanced tympanosclerosis (TS) and to present the comparison of pre-and postoperative audiometric results., Methods: 21 patients suffering from advanced TS (Only type III and IV patients according to Wielinga-Kerr classification) were enrolled in this prospective study. A pure transcanal endoscopic approach was preferred for all patients included in the study. Titanium malleus replacement prosthesis (MRP) and polytetrafluoroethylene (PTFE) loop prosthesis combination were used to bypass fixed ossicles to achieve sound transmission to the inner ear. Pre-and postoperative pure tone audiometry (PTA) measurements and air-bone gap (ABG) results compared, and surgical technique was considered successful if postoperative ABG was less than 20 dB., Results: Six of the 21 patients had been operated on before and the tympanic membrane (TM) was intact. The remaining 15 of the 21 patients were the primary cases, and TM perforation repair and ossiculoplasty using combination of the MRP and PTFE loop prosthesis were performed at single-staged operation. The average preoperative ABG values significantly improved from 37.1 ± 6.2 to 14.5 ± 1.2 dB postoperatively (p < 0.001). The mean preoperative air conduction threshold (ACT) significantly decreased from 51.7 ± 11.4 to 28.5 ± 9.1 dB (p < 0.001)., Conclusion: TS surgery is still a controversial issue particularly in stapes footplate fixation. However, our surgical and audiological results in this study are quite promising. The combination of titanium MRP and PTFE loop prosthesis for restoring sound transmission in advanced TS cases is reliable, effective and novel treatment option via endoscopic transcanal approach., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Comparison of the hearing outcomes of titanium partial ossicular replacement prosthesis (PORP) vs. titanium total ossicular replacement prosthesis (TORP) with footplate shoe (Omega Connector) in second stage ossicular chain reconstruction surgeries., Methods: In this retrospective cohort study in a tertiary hospital, we compared the hearing outcomes in 248 patients who had undergone ossicular chain reconstruction with titanium prostheses PORP (n = 115) vs. TORP (n = 133) from August 2017 to June 2021. Pre-and post-operative audiometric data were assessed., Results: In general, we found that there were no significant differences between PORP and TORP groups in gains of BC (P = 0.080), AC (P = 0.454), ABG (P = 0.928), SRT (P = 0.065), and SDS (P = 0.363). There were no significant differences in terms of ABG gain between the two groups. Regarding ABG gains frequency-specific analysis in the ears with pre-operative conductive hearing loss, there were no significant differences between low-frequencies (P = 0.260) and high-frequencies (P = 0.973) between the two groups., Conclusion: To sum up, this research provided additional evidence with respect to hearing outcomes after staged ossicular chain reconstruction with PORP and TORP. The practical application of our study is that TORP with footplate shoe (Omega Connector) is comparable with PORP in staged ossiculoplasty., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: To evaluate the efficacy of ossicular chain reconstruction (OCR) in primary and revision surgeries, and to investigate the impact of the number of previous surgeries on hearing outcomes., Methods: Retrospective analysis of cases with OCR due to chronic otitis in a tertiary center between January 2018 and September 2021., Results: Altogether, 147 cases of ossicle involvement were assessed. In 91.83% (n = 135) OCR was performed, 96.26% of them with titanium TORP/PORP (n = 130), two cases with autologous prosthesis and three with piston. Mean follow-up was 8.8 months. The ABG significantly improved in the total group (TORP/PORP) from a mean (SD) of 30.94 (15.55) to 19.76 (13.36) dB (p < 0.0001) with 60.86% success. The best results were achieved in primary OCR with PORP implantation without cholesteatoma (89.47%). Primary cases have a significantly higher success rate in contrary to revision surgeries (72.27%, vs. 52.00%, p = 0.032). The only relevant predictive factor proved to be the fact of revision (p = 0.029). A statistically significant correlation between the number of previous surgeries and hearing results could not be proved. There was no difference in hearing outcomes between patients with only one or more than one previous surgeries in the revision groups. Neither the presence of cholesteatoma, nor the type of OCR (TOPR/PORP) and the indication of revision had an impact on postoperative ABG., Conclusions: Titanium prostheses are effective in OCR both in primary and revision cases. It is not the number of previous surgeries, but the fact of revision that influences postoperative hearing results., (© 2023. The Author(s).)

Purpose: Different techniques are used to fix crimp and CliP® Piston stapes prostheses to the long process of the incus (LPI). The CliP® Piston provides a stiff connection in contrast to the static bended loop of the crimp prosthesis, which imitates the physiological incudostapedial joint (ISJ) and thereby potentially leads to different hearing outcome., Methods: In a retrospective single-center study of German-speaking one hundred and ninety patients who underwent stapes surgery CliP® Piston or crimp prostheses between the years of 2016 and 2019 by the same surgeon and in the same setting. Pre- and postoperative bone- (BC) and air-conduction (AC) pure-tone thresholds, pre- and postoperative air-bone gap (ABG) for 0.5, 1, 1.5, 2, 3, 4 kHz and the surgery time were examined., Results: The postoperative bone conduction thresholds were significantly lower in the frequencies between 0.5 and 3 kHz and the mean ABG was < 10 dB in most cases independent of the prosthesis used. Crimp prosthesis showed a significantly better closure of the ABG at 0.5 kHz., Conclusions: The audiological outcome after stapes surgery is dependent on the type of prosthesis used, as reflected by the frequency-specific air-bone gap. The better ABG closure with the crimp prosthesis might be the result of the connection to the LPI imitating the physiological ISJ. The crimp prosthesis may be the better choice if use of hearing aids is expected postoperatively., (© 2023. The Author(s).)

Introduction: Patients with otitis media (OM) encounter significant functional hearing impairment with conductive, or a combined hearing loss and long-term sequelae involving impaired speech/language development in children, reduced academic achievement and irreversible disorders of middle and inner ear requiring a long time therapy and/or multiple surgeries. In its persistent chronic form, Otitis media (COM) can often only be treated by undergoing ear surgery for hearing restoration. The persistent inflammatory reaction plays a major role, often caused by multi-resistant pathogens in the ear. Herein, we present outcomes of patients implanted with currently the only FDA approved active Middle Ear Implant Vibrant Soundbridge (VSB), suffering from persistent COM., Methods: The study enrolled 42 patients, treated by performing middle ear (ME) surgery to different extents and implanted with the VSB to various structures in the ME. Included were 17 children and 25 adults that had recurrent and/or persisting OM and significant hearing loss. Preoperative and postoperative patients' audiometric data were evaluated and the benefit with VSB assessed using the Glasgow Benefit Inventory for adults and pediatric cohorts. The microbial spectrum of pathogens was assessed before and after surgery, exploring the colonization of the otopathogens, as well as the intestinal microbiome from individually burdened patients., Results: The mean functional gain is 29.7 dB HL (range from 10 to 56.2 dB HL) with a significant improvement in speech intelligibility in quiet. Following VSB implantation, no significant differences in coupling were observed at low complication rates. Postoperatively patients showed significantly increased benefit with VSB compared to the untreated situation, including less otorrhea, pain, medical visits, and medication intake, with no recurrent OM and significant bacterial shift in otopathogens. The analysis of the intestinal microbiome displayed a high abundance of bacterial strains that might be linked to chronic and persistent inflammation., Conclusions: Functional ear surgery including rehabilitation with a VSB in patients suffering from COM present to be safe and effective. The successful acceptance accompanied by the improved audiological performance resulted in significant benefit with VSB, with a shift in the ear pathogens and altered microbiome and thus is a great opportunity to be treated., (© 2023. The Author(s).)

Introduction: The Vibrant Soundbridge (VSB) is a semi-implantable hearing aid for patients with various types of hearing loss and has been available for over 25 years. Recently, new audio processors with advanced signal processing, noise reduction, and multi-microphone technology have appeared. The aim of this study is to compare the benefits of using the newest Samba 2 processor to the previous generation processors in a group of experienced VSB users., Methods: There were 22 experienced VSB users (mean time of using VSB was 9 years, SD = 2) who had their processor (D404 or Amadé) upgraded to the newest model (Samba 2). The mean age of the subjects was 56 years (SD = 20). Assessments were made by free-field audiometry, speech reception in quiet and noise, and Patient-Reported Outcome Measures (PROMs)., Results: Hearing tests in free field showed statistically significant improvements in hearing sensitivity and speech discrimination in quiet and noise with the Samba 2 audio processor compared to the earlier technology. PROMs confirmed the benefits of using the newest audio processor and there was more satisfaction in terms of usability., Conclusions: Access to modern technology for VSB patients provides measurable benefits., (© 2022. The Author(s).)

Purpose: to assess audiological performance in quiet and noise, quality of life and side effects of Vibrant Soundbridge (VSB) in children with congenital aural atresia (CAA)., Methods: A retrospective study including consecutive patients with unilateral or bilateral CAA implanted with VSB from 2009 to 2020 in a tertiary referral centre., Results: 18 patients with CAA and a present stapes were included (3 simultaneous bilateral VSB implants) and 21 ears: 17 VSB were attached to the short incus process, and four to the stapes. Age at implantation ranged from 4.7 to 15.8 years. Average follow-up was 6.5 years (± 3.7 years). In unilateral VSB, air conduction pure tone average (ACPTA) thresholds increased from 75.3 ± 15.2 to 32.6 ± 8.3 dB post-operatively (VSB activated) (n = 15; p < 0.01). The speech reception threshold (SRT) and the word recognition score (WRS) were significantly improved from 81.5 ± 10.4 to 43.9 ± 7.6 dB and 0% to 84.8 ± 8.5% postoperatively (n = 15; p < 0.01). The signal to noise ratio (SNR) was significantly improved from 2.1 ± 2.9 dB VSB inactivated to 0.3 ± 2.7 dB VSB activated (n = 15; p < 0.01). There was no significant difference in performance according to floating mass transducer (FMT) placement. 5/15 children were non-users at last follow-up in unilateral VSB and 0/3 in bilateral., Conclusions: CAA ears with VSB activated had a significant improvement of ACPTA, WRS, SRT and SNR. A third of patients with unilateral CAA became non-users at last follow-up. The main challenge is to target the indications for the implantation of the VSB to avoid its discontinuation., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: Studies have assessed the trauma and change in hearing function from the use of otological drills on the ossicular chain, but not the effects of partial laser ablation of the incus. A study of the effectiveness of a novel middle-ear microphone for a cochlear implant, which required an incus recess for the microphone balltip, provided an opportunity to compare methods and inform a feasibility study of the microphone with patients., Methods: We used laser Doppler vibrometry with an insert earphone and probe microphone in 23 ears from 14 fresh-frozen cadavers to measure the equivalent noise level at the tympanic membrane that would have led to the same stapes velocity as the creation of the incus recess., Results: Drilling on the incus with a diamond burr created peak noise levels equivalent to 125.1-155.0 dB SPL at the tympanic membrane, whilst using the laser generated equivalent noise levels barely above the baseline level. The change in middle ear transfer function following drilling showed greater variability at high frequencies, but the change was not statistically significant in the three frequency bands tested., Conclusions: Whilst drilling resulted in substantially higher equivalent noise, we considered that the recess created by laser ablation was more likely to lead to movement of the microphone balltip, and therefore decrease performance or result in malfunction over time. For patients with greatly reduced residual hearing, the greater consistency from drilling the incus recess may outweigh the potential benefits of hearing preservation with laser ablation., (© 2022. The Author(s).)

Purpose: The relatively new technique of trans-canal endoscopic ear surgery (TEES) when compared to microsurgery for ossiculoplasty has advantages of better visualization and no external incision but also has the disadvantage of being a one-handed procedure. Our study aimed to compare audiometric outcomes following ossiculoplasty performed via TESS with results of microsurgery., Materials and Methods: Data from a prospective audit of 157 consecutive patients who underwent ossiculoplasty by a single otologist from 2009 to 2018 was analyzed. TEES was introduced in the department in 2014; therefore, all patients before this period underwent microsurgery. Patients were classified by surgical approach, TEES, or microsurgery. Audiological outcomes were recorded at 3 and 12 months postoperatively and compared to pre-operative levels. Other variables included were the condition of stapes and reconstruction material used., Results: Of the 157 cases, 50 were TEES and 107 were microsurgery (81 microscope only and 27 combined with endoscope). There was statistically significant improvement (p < 0.001) in AC (43.4 dB pre-operatively, 36.2 dB postoperatively), BC (20.3 dB pre-operatively, 17.6 dB postoperatively), and ABG (21.8 dB pre-operatively, 16.7 dB postoperatively) in the total cohort. Both groups achieved an ABG better than 20 dB; 72% in TEES, 73% in the microscopic group, and there was no significant difference. There was no change in hearing at 12 months when compared to 3 months. No statistically significant difference was noted based on stapes condition, type of material used for ossiculoplasty, or tympanic membrane graft., Conclusion: TEES is safe and as effective as microsurgery in ossiculoplasty with possibly much less pain and morbidity., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: In most stapes surgeries, the posterior ear canal is enlarged and a piston is inserted posterior to the chorda tympani nerve (post-chorda tympani approach; Post C). Although reports vary, some indicate that more than 60% of the patients experience lingual symptoms following surgery. Endoscopic surgery may permit an anterior approach to the nerve (pre-chorda tympani approach; Pre C). Herein, we propose a suitable approach for endoscopic stapes surgery based on the classification of the chorda tympani nerve., Methods: We retrospectively reviewed the medical records of 23 patients who underwent endoscopic stapes surgery at our institution between 2019 and 2021. The nerve classification previously reported, the modified nerve classification (attached long type is divided into Category 1: lenticular process is visible with 0° endoscope and Category 2: not visible), selected approach (Pre C or Post C), use of a 30° endoscope, and manipulation of the nerve (number of contacts and traction, with or without suction, with or without malposition or extension and amputation, and damage score) were evaluated., Results: The damage score was significantly lower in the Pre C group (p < 0.05); however, using this approach for all cases is not desirable owing to the high risk of damage to the nerve during posterior malpositioning., Conclusion: The Post C should be used for the detached and attached long 1 types, while the Pre C with a 30° endoscope should be used for the attached long 2, attached short, ultrashort, and external auditory canal types., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: To evaluate the efficacy and safety of a titanium total prosthesis (TORP) in ossicular chain reconstruction., Methods: Retrospective analysis of 113 cases of total ossicular chain reconstruction performed by a single surgeon between 2006 and 2018. Follow-up lasted until January 2020. Participants were patients with chronic otitis media, cholesteatoma, or ossicular chain disruption., Results: Mean preoperative air-bone gap (± standard deviation) was 32.74 dB (± 11.62). Mean postoperative air-bone gap was 21.68 (± 11.29). Mean air-bone gap improvement was 11.06 dB (± 14.99) (p < 0.001). 57 cases had a post-operative air-bone gap smaller than or equal to 20 dB (50.44%). In four cases, prosthesis dislocation was observed (12.39%). Mean prosthesis length in this group was 5.29 mm (± 0.86) versus 4.36 mm (± 1.02) in cases without prosthesis dislocation (p = 0.002)., Conclusions: Total ossicular reconstruction using a titanium prosthesis yields favorable functional results, also during prolonged follow-up. Prosthesis length was significantly longer in cases with prosthesis dislocation., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Purpose: The Vibrant Soundbridge (VSB) was introduced in 1996, and the fourth generation of the audio processor recently released. This clinical study evaluates the audiological performance and subjective satisfaction of the new SAMBA 2 audio processor compared to its predecessor, SAMBA., Method: Fifteen VSB users tested both audio processors for approximately 3 weeks. Air conduction and bone conduction thresholds and unaided and aided sound field thresholds were measured with both devices. Speech performance in quiet (Freiburg monosyllables) and noise (OLSA) was evaluated as well as subjective listening effort (ACALES) and questionnaire outcomes (SSQ12 and APSQ). In addition, data from 16 subjects with normal hearing were gathered on sound field tests and ACALES., Results: Both audio processors showed substantial improvement compared to the unaided condition. The SAMBA and SAMBA 2 had comparable performance in sound filed thresholds, while the SAMBA 2 was significantly better in speech in quiet, speech in noise, reduced listening effort, and improved subjective satisfaction compared with the SAMBA., Conclusion: The SAMBA 2 audio processor, compared to its predecessor SAMBA, offers improved performance throughout the parameters investigated in this study. Patients with a VSB implant would benefit from an upgrade to SAMBA 2., (© 2021. The Author(s).)

Purpose: We assessed overall hearing outcome after tympanoplasty type III in chronically infected ears with cholesteatoma (CH) and without cholesteatoma: otitis media chronica mesotympanalis, tympanosclerosis, and adhesive process (COM&#95;T&#95;AP)., Methods: 303 surgeries were evaluated: 229 CH-group and 74 COM&#95;T&#95;AP-group. Air-bone gaps (PTA-ABG) with pure-tone averages (PTA-4) at four frequencies (0.5, 1, 2 and 4 kHz) were compared preoperatively, early postoperatively (< 40 days) and late postoperatively (40-400 days). Hearing outcome was compared in various types of middle-ear reconstruction and in smokers and non-smokers. Correlations between hearing outcome and predictive staging indices were evaluated: Middle Ear Risk-Index (MER-I) and Ossiculoplasty Outcome Parameter Staging-Index (OOPS-I)., Results: Mean PTA-ABG in the CH-group increased from 20.9 ± 11.3 dB to 22.3 ± 10.4 dB early postoperatively and decreased significantly to 19.2 ± 10.1 dB late postoperatively. Mean PTA-ABG in the COM&#95;T&#95;AP-group decreased significantly from 27.3 ± 10.9 dB to 20.6 ± 10.9 dB early postoperatively and decreased to 20.0 ± 12.2 dB late postoperatively. No significant difference was seen between PTA-ABG-closures of partial or total ossicular replacement prosthesis (PORP/TORP) and cartilage ossiculoplasty in the CH-group. Patients receiving TORP showed a significantly higher preoperative PTA-ABG. All reconstruction types exhibited postoperative PTA-ABG around 20 dB. In the COM&#95;T&#95;AP-group, smokers had a significantly higher mean PTA-ABG early postoperatively; this equalized with that of non-smokers late postoperatively. PTA-ABG-closures and MER-I or OOPS-I were not significantly correlated., Conclusion: Tympanoplasty type III maintains hearing in patients with cholesteatoma and significantly improves hearing in chronically inflamed ears without cholesteatoma. All investigated ossicular replacement prostheses are equally beneficial. Healing postoperatively takes longer in smokers, but they eventually catch up with non-smokers., (© 2022. The Author(s).)

Objectives: The objectives of this study are to describe our experiences in endoscopic transcanal management of tympanosclerosis, to explain our surgical approaches to reconstruct the sound conduction system and to analyze the hearing results obtained with our surgical approaches., Study Design: A retrospective cohort study, using medical records of 28 cases that underwent endoscopic transcanal tympanoplasty surgery due to tympanosclerosis from January 2016 to January 2020., Settings: Private otology clinic PATIENTS: Twenty-eight ears of 26 patients were enrolled into study. Patients were grouped according to Wielinga-Kerr classification and only type II, III and IV patients were included in the study., Interventions: Exclusively transcanal endoscopic surgery was performed in all cases. Primary goal was to mobilize the affected ossicles by removing the offending TS and reconstruct the ossicular chain. Malleostapediopexy was preferred when attic by-pass procedures were needed. Glass ionemer bone cement was used to reconstruct the ossicular defects., Outcome Measures: Preoperative and postoperative pure tone average of air conduction and bone conduction and air-bone gap results were evaluated. Operation was considered successful if postoperative ABG < 20 dB was achieved. Complications and graft take rate were also evaluated., Results: Single-staged surgery was performed in 23 of 28 cases (82.1%). Graft take rate was 93%. The mean preoperative ABG significantly decreased from 33.9 ± 5.19 to 12.55 ± 5.52 dB postoperatively for 23 cases who had single-staged surgeries (p < 0.001, Wilcoxon signed rank test) at the end of the mean follow-up period of 23 months. For this group, the mean preoperative AC-PTA significantly improved from 48.64 ± 9.30 to 22.93 ± 7.45 dB (p < 0.001, Wilcoxon signed rank test) postoperatively with a mean PTA improvement of 25.71 ± 6.02 dB. Success criterion was achieved in 22 of 23 cases (95.7%). There was no sensorineural hearing loss, facial nerve paralysis and postoperative vertigo after the surgical procedures. All patients had been discharged within the first 24 h., Conclusions: Surgical treatment of tympanosclerosis is still a controversial issue. Endoscopic surgery seems a safe technique for the management of tympanosclerosis. Single-stage surgery is possible in most of the cases with a satisfactory hearing result. We speculate that addition of endoscopic view may increase the single-stage surgery ratio., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

Purpose: To report on failures related to active middle ear implants (AMEI) surgery, within a series of subjects treated at a single Implanting Center., Methods: A retrospective review of 79 cases of implanted AMEI has been performed to report the failure ratio, the causes for the failure and the selected rehabilitative solution. The AMEI included 25 Vibrant Soundbridge ® (Medel, Innsbruck, Austria), 20 as round window vibroplasty (RW-VSB) for mixed hearing loss, 5 as incus-vibroplasty for sensorineural hearing loss; 7 MET/Carina ® (Cochlear, Melbourne, Australia), 2 MET for mixed and sensorineural hearing loss, 5 Carina for sensorineural hearing loss; 43 Esteem ® (EnvoyMedical, St Paul, USA) for sensorineural hearing loss; 3 Maxum ® (Ototronics, Texas, USA) for sensorineural hearing loss; 1 Codacs ® (Cochlear, Melbourne, Australia) for severe mixed hearing loss., Results: The overall complication rate affected 20% of the implanted devices, individually ranging from 6.9 to 100%. Hardware system failures were recorded in all the AMEI, ranging from 10 to 50%. The alternative auditory rehabilitation included replacement of the same system in 2 cases, use of a conventional hearing aid in 3 cases, Cochlear implantation in 4 cases and implantation in the contralateral ear in 2 cases., Conclusion: The present clinical experience showed that, in spite of the successful functional rate displayed by the majority of the AMEI implantees, complications may occur to a certain percentage of cases and should prompt the professionals to select alternative solutions, starting from the (re)adoption of a conventional hearing aid and ending up to Cochlear implantation., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

Purpose: To evaluate the forces involved in different manipulations, manual or robot-assisted, applied to the ossicular chain, on normal temporal bones and on an anatomical model of otosclerosis., Methods: Thirteen cadaveric temporal bones, with mobile footplates or with footplates that were fixed using hydroxyapatite cement, were manipulated, manually or using a robotic arm (RobOtol®). "Short contact" of a mobile footplate was the weakest interaction on the incus. "Long contact" was the same manipulation held for 10 s. "Mobilization" was the smallest visualized movement of the mobile footplate, or the movement necessary to regain mobility of the fixed footplate. A six-axis force sensor (Nano17, ATI) measured the maximal peak of forces, summation of forces applied, and yank., Results: Maximal forces during short (~4 mN) and long contact (~15 mN) were similar for manual and robot-assisted manipulations. For manual manipulation, yank measured during long contact was twice as high compared to robot-assisted manipulation: 6 ± 2.4 (n = 5) and 3 ± 1.3 mN/s (n = 5), respectively (mean ± SD, p < 0.02). For mobilization of the mobile footplate, maximal forces during mobilization were similar during manual and robot-assisted manipulations, respectively: 12 ± 2.5 (n = 6) and 19 ± 7.6 mN (n = 7). Compared with mobilization of a mobile footplate, mobilization of a fixed footplate required ~ 60 and ~ 27 times higher maximal forces for manual and robot-assisted manipulations, respectively: 724 ± 366.4 and 507 ± 283.2 mN. Yank was twice as high during manual manipulation compared to robot-assisted manipulation (p < 0.05)., Conclusion: Robot-assisted manipulation of the ossicular chain was reliable. Our anatomical model of otosclerosis was successfully developed requiring higher forces for stapes mobilization., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH, DE part of Springer Nature.)

Objective: These days, the gold standard procedure for otosclerosis treatment is stapes surgery. The endoscopic approach of the procedure is gaining popularity as endoscopic ear surgery develops across the globe. The main objective of this study is to gather and compile well-documented and reliable data regarding surgical outcomes for the endoscopic approach to stapes surgery up to this date., Materials and Methods: Publications in English were searched in the PUBMED/MEDLINE database and were systematically reviewed. A total of 16 articles were reviewed according to the inclusion criteria, obtaining a total of 573 patients managed surgically for otosclerosis, using an endoscopic approach. Data were systematically extracted and compared across variables., Results: Data were obtained as follows: mean age of 43 years; female proportion of 60%; 3 mm endoscope diameter of 51%, 4 mm of 39%; titanium piston-type prostheses of 52% and Teflon of 48%; length of the prosthesis (mode) was 4.5 mm; 0.6 mm diameter of the piston of 81% and 0.4 mm of 19%; mean surgical time was 55 min. Hearing results, mean preoperative air-bone gap (ABG) 31 dB; mean postoperative ABG 9 dB; ABG improvement of 22 dB; an ABG closure rate to 20 dB or less of 92% and an ABG closure rate to 10 dB or less of 77%. Complication rates: intraoperative tympanic membrane perforation of 5%; postoperative vertigo of 11%; postoperative dysgeusia of 10%; reported a postoperative neurosensorial hearing loss of 0.2%; reported gusher phenomenon of one case (0.2%)., Conclusion: Endoscopic stapes surgery is completely achievable using 0º angle and 4-mm-diameter sinus surgery endoscope. Instrument availability should not be an obstacle to the development of this type of surgery in any otolaryngology department. Audiological outcomes are comparable to microscopic approaches.

Purpose: Evaluating the effectiveness of intraoperative auditory brainstem responses (ABRs) to stimulation by the Vibrant Soundbridge (VSB) active middle ear implant for quantifying the implant's floating mass transducer (FMT) coupling quality., Methods: In a diagnostic multicentric study, patients (> 18 years) who received a VSB with different coupling modalities were included. Pre- and postoperative bone conduction thresholds, intraoperative VSB-evoked ABR thresholds (VSB-ABR) using a modified audio processor programmed to preoperative bone conduction thresholds, postoperative vibrogram thresholds, and postoperative VSB-ABR thresholds were measured. Coupling quality was calculated from the difference between the pure tone average at 1000, 2000, and 4000 Hz (3PTA) vibrogram and postoperative 3PTA bone conduction thresholds., Results: Twenty-three patients (13 males, 10 females, mean age 56.6 (± 12.5) years) were included in the study. Intraoperative VSB-ABR response thresholds could be obtained in all except one patient where the threshold was > 30 dB nHL. Postoperatively, an insufficient coupling of 36.7 dB was confirmed in this patient. In a Bland-Altman analysis of the intraoperative VSB-ABRs and coupling quality, the limits of agreement exceeded ± 10 dB, i.e., the maximum allowed difference considered as not clinically important but the variation was within the general precision of auditory brainstem responses to predict behavioral thresholds. Five outliers were identified. In two patients, the postoperative VSB-ABR thresholds were in agreement with the coupling quality, indicating a change of coupling before the postoperative testing., Conclusion: The response thresholds recorded in this set-up have the potential to predict the VSB coupling quality and optimize postoperative audiological results.

Aim: The fully implantable middle ear implant (C-FI-MEI) is designed for patients with moderate-to-severe sensorineural hearing loss or those with mixed hearing loss. To analyze the audiological post-operative results of subjects bilaterally implanted with C-FI-MEI., Materials and Methods: Retrospective study: 14 patients with bilateral, moderate-to-severe, sensorineural or mixed hearing loss were treated. This clinical sample included 14 cases bilaterally implanted (13 sequentially, 1 simultaneously). The evaluation at each follow-up after surgery included otologic examination, a structured interview, and different audiological tests composed of pure tone audiometry, speech in quiet and in noise test, and localization task. The mean follow-up was 67.2 ± 33 months., Results: There were no significant differences between pre and post-operative pure tone averages. The patients showed no significant differences between pre-operatively aided and C-FI-MEI implant-aided conditions in terms of word recognition score. Speech perception in noise under different loudspeaker arrangements and localization tests demonstrated a binaural advantage in bilaterally implanted patients. The mean daily use time was 17.4 and 16.7 h, respectively, for right and left side., Conclusion: The results for the 14 patients, bilaterally implanted with C-FI-MEI, suggest that bilateral implantation of fully implantable middle ear hearing devices is an effective procedure., Level of Evidence: 4.

Purpose: The learning curve in endoscopic stapes surgery, is flat and long. There is limited space during training for advanced and salvage procedures, which could be necessary in unexpected intraoperative scenarios. The aim of the present study is to develop an ex-vivo animal model for training in salvage and advanced procedures in endoscopic stapes surgery METHODS: After defining the difficult intraoperative scenarios requiring a salvage procedure during stapes surgery, we used the ovine model to create those intraoperative situations. After assessing the suitability of the model for that purpose, it was validated by subjective feedback rating (scale from 1 to 10) and by comparing the relevant anatomical structures for stapes surgery with the human. Finally, an optimal sequence of surgical steps was defined., Results: 8 Fresh frozen lamb heads (16 ears) were studied. The selected intraoperative scenarios were: floating footplate, footplate fracture, luxation of the incus or necrosis of the long process, overhanging facial nerve, obliterative otosclerosis. The simulation resulted feasible and close to real. The mean overall rating for surgical scenarios ranged from 7.5 to 8.8 for residents and was consistent with the rating of senior surgeons, ranging from 7.67 and 9.0. Anatomical measures of the oval window area resulted similar between the ovine and the human., Conclusion: The ex-vivo ovine model is a suitable model for training in salvage and advanced procedures in exclusively endoscopic stapes surgery. The model can be used both for the training and maintenance of the acquired advanced skills in endoscopic stapes surgery.

Purpose: The aims of this article are: (1) is there an ideal incudostapedial joint (ISJ) angle after stapedotomy? (2) is there any difference between pre- and postoperative ISJ angle? and (3) what is the significance of the ISJ angle in postoperative hearing outcomes?, Methods: Forty six ears from 39 different adult patients (28 women and 11 men; 21 left and 25 right ears) with a mean age of 39 years with clinical otosclerosis who underwent stapedotomy between May 2017 and May 2019 were retrospectively registered, including seven bilateral surgery cases. ISJ angle and intravestibular depth of the stapes prosthesis were measured from multiple planar reconstruction-computed tomography images and the length of the prosthesis was measured during surgery. Relationships between the ISJ angle parameters and postoperative hearing outcomes and parameters of the prosthesis were analyzed., Results: The mean ISJ angle was 93.3° ± 8.8° preoperatively and 101.9° ± 6.3° postoperatively, increasing by 8.6° during stapedotomy (p < 0.01). There were weak and negative correlations between ISJ angle changes and postoperative air conduction gains at frequencies ≤1 kHz and bone conduction gains at 0.5 kHz. When the postoperative ISJ angle changed more than 20°, the success rate of the procedure decreased to 0%., Conclusion: The stapedotomy operation increased the ISJ angle. The success of postoperative auditory outcomes had more to do with the ISJ angle change than the value of the angle itself, indicating there is no universal ideal ISJ angle that surgeons should aim for during stapedotomy.

Purpose: Most studies regarding residual and recurrent cholesteatoma focus on single relapse. This study examines patients who had to undergo at least three surgeries for complete eradication of their cholesteatoma, with the aim of bringing to light risk factors and assessing the functional impact of multiple surgeries on hearing., Method: We include 27 patients who underwent 3 consecutive surgeries for cholesteatoma between 2006 and 2016. This population represented 3.1% of all cholesteatoma operated on during that same period (868 patients)., Results: Cases of multi-residual and/or recurrent cholesteatoma (RRC) were significantly younger (13.1 years old), than single-RRC or cases with No-RRC (respectively, 28.0 and 38.5 years old) (p < 0.01). Furthermore, there was a significant difference in cholesteatoma location especially for combined attical and mesotympanic location between the three groups (no-RCC 26%; single-RRC 34% and multi-RRC 66%) (p < 0.01). There was also a significant difference in ossicular erosion of the malleus, incus and stapes between the three groups (p < 0.01). In our study, the type of surgery did not influence multi-RRC rates. We did not observe any significant impact on hearing between the first and third surgeries. Mean duration between the first and second surgeries was significantly shorter for multi-RRC (14.5 months SD 8.3) than for single-RRC (23.3 months SD 18.1) (p < 0.05)., Conclusion: Special care should be given in case of combined attical and mesotympanic extension, ossicular erosion and young children. Delaying the realization of MRI, and/or of second-look surgery, could decrease the risk of multi-RRC.

Objective: This study assessed the safety and sound-localisation ability of the Vibrant Soundbridge (VSB) (Med-EL, Innsbruck, Austria) in patients with unilateral microtia and atresia (MA)., Methods: This was a single-centre retrospective research study. Twelve subjects with unilateral conductive hearing loss (UCHL) caused by ipsilateral MA were recruited, each of whom underwent VSB implantation and auricular reconstruction. The bone-conduction (BC) threshold was measured postoperatively, and the accuracy of sound localisation was evaluated at least 6 months after surgery. Horizontal sound-localisation performance was investigated with the VSB activated and inactivated, at varying sound stimuli levels (65, 70 and 75 dB SPL). Localisation benefit was analysed via the mean absolute error (MAE)., Results: There was no statistical difference in mean BC threshold of impaired ears measured preoperatively and postoperatively. When compared with VSB-inactivated condition, the MAE increased significantly in unilateral MA patients in the VSB-activated condition. Besides, sound-localisation performance worsened remarkably when sound was presented at 70 dB SPL and 75 dB SPL. Regarding the side of signal location, the average MAE with the VSB device was much higher than that without the VSB when sound was from the normal-hearing ear. However, no significant difference was observed when sound was located from the impaired ear., Conclusion: This study demonstrates that in patients with unilateral MA, the VSB device does not affect inner-ear function. Sound-localisation ability is not improved, but deteriorated at follow-up. Our results suggest that the VSB-aided localisation abilities may be related to the thresholds between the ears, plasticity of auditory system and duration of use of VSB.

Purpose: To evaluate the safety and performance of three novel vibroplasty couplers that allow attachment of the floating mass transducer of a transcutaneous active middle ear implant (AMEI) to the round window (RW) membrane, the long process (LP), or the incus body and the short process (SP) of the incus., Methods: Retrospective multicenter cohort study of 25 AMEI users with sensorineural or mixed hearing loss that were among the first implanted with an AMEI vibrating ossicular prosthesis in combination with the third generation of vibroplasty couplers between 2014 and 2016. Main Outcome Measures were bone-conduction pure-tone and vibroplasty thresholds, postoperative aided sound field thresholds and postoperative aided word recognition score (WRS)., Results: Bone conduction threshold changes of more than 10 dB in 4PTA BC were observed in two subjects. A mean improvement of 57.8% in speech recognition was observed with a mean WRS at 65 dB SPL improving from 14.8% (SD 21.9%) preoperatively to a mean aided score of 72.6% (SD 18.6%). Sound field thresholds improved from an average 4PTA SF of 64.1 dB HL (SD 9.8 dB HL) to 37.0 dB HL (SD 8.9 dB HL), resulting in a mean functional gain of 27.1 dB. There was no significant difference in WRS or functional gain between the coupler types., Conclusion: Initial experience shows that all three third generation vibroplasty couplers represent safe and efficient attachment options for the FMT allowing the surgeon to choose the coupling type based on the present pathology.

Purpose: To evaluate the long-term audiological outcomes and safety of the latest generation of middle ear transducer (MET) among a group of Polish patients., Methods: Ten patients aged 48-72 years with bilateral sensorineural hearing loss (n = 8) and mixed hearing loss (n = 2) were included in this study. Pure tone audiometry, sound thresholds, word recognition scores in quiet and speech reception thresholds in noise were assessed. Medical and technical complication information was gathered., Results: All the patients underwent unilateral implantation with the latest generation Cochlear MET between 2014 and 2016. Mean length of follow-up was 3.7 years. Compared to the unaided condition, the implant provided significant functional gain (mean M = 26.1 dB) at 12 months follow-up. Compared to before surgery, average word recognition in quiet at 65 dB and at 80 dB SPL, as well as speech reception threshold in noise, were significantly better at 12 months. However, postoperative air conduction thresholds 6 months after implantation worsened by 10.3 dB (standard deviation SD = 5.8 dB). Postoperatively, three patients had skin problems around the processor, and one of them completely resigned from using the device 5 months after activation. Technical failures occurred in 4 cases. There were 9 out of 10 patients who still used the MET, but only 5 of them used the processor regularly (every day)., Conclusion: Despite changes in the transducer implemented by the manufacturer, we observed a significant number of adverse events in users of the latest generation of MET.

Purpose: This paper reports the surgical and audiological outcomes of a large series of patients who received a fully implantable middle ear implant (MEI): carina (Cochlear, Australia)., Methods: This is a multicentre retrospective study involving three tertiary referral centres. Patient data were collected for the first 42 consecutive patients who were fitted with the MEI between 2014 and 2019 (Sheffield from February 2017 to January 2019; São Paulo from April 2015 to September 2017; Porto from December 2014 to May 2017). The main outcome measures included surgical results, free field speech testing with speech recognition thresholds (SRT) and audiological gain., Results: There was one major complication due to infection resulting in a brain abscess and explantation of the device. Three other patients had minor skin infections; no other complications were reported. Results show a functional gain of 19.5 dB (p < 0.05) with the MEI versus unaided condition. SRT improved from 57.4 dB to 44.6 dB with the MEI (p < 0.05)., Conclusions: This fully implanable active MEI offers a reliable option for patients with moderate-to-severe sensorineural or mixed hearing losses especially for those do not tolerate or cannot use conventional hearing aids. It provides significant improvement in hearing as shown in the audiological outcomes. The surgery is relatively straightforward but there is a steep learning curve. The devices are well tolerated by all patients.

Objectives: To analyze health-related quality of life (HRQoL) and audiological results after stapes surgery using a Nitinol Head Prosthesis (NHP)., Methods: Study-Design Prospective longitudinal study. Patients Patients undergoing stapes surgery for otosclerosis and stapes reconstruction with a NHP between January 2018 and December 2018 (n = 48). Intervention Audiological measurements preoperatively and at 6 months follow-up as well as two questionnaires assessing HRQoL, i.e., the Stapes Plasty Outcome Test 25 (SPOT-25) and the Glasgow Benefit Inventory (GBI). Main outcome measures Correlation of pure tone average (4PTA 0.5-3 kHz) with questionnaires assessing HrQOL preoperatively and at follow-up after stapes surgery., Results: Patients showed a significantly reduced air-bone-gap (ABG, 0.5, 1, 2, 3 kHz) at the follow up visit (median: 11.3 dB, IQR 5.0-14.4) compared to the preoperative measurements (median 27.5 dB, IQR 21.9-36.3). Disease-specific HRQoL improved significantly in all scales of the SPOT-25 apart from the subscore "tinnitus". Postoperatively, the subscore "hearing function" correlated well only with the ABG (r = 0.59, p = 0.001). The SPOT-25 and GBI total scores showed a moderate negative correlation (r = - 0.59, p = 0.008)., Conclusions: Stapes surgery leads to significant improvements of hearing and the HRQoL. However, correlations between HRQoL questionnaire scores and the audiometric outcomes were inconclusive, indicating that the use of HRQoL measures for the assessment of stapedotomy outcomes to complement objective outcomes should be encouraged.

Purpose: This study aimed to evaluate hearing results in patients with type 3 tympanoplasty using autologous cartilage grafts., Methods: The study included patients treated with "stapes stabilizing cartilage graft" (SSCG) and Plastipore partial ossicular replacement prosthesis (PPORP) for hearing reconstruction. Hearing results and complications were assessed and postoperative audiological tests were performed at least 6 months after surgery., Results: There were 18 patients (5 men, 13 women) in the SSCG group and 12 patients (5 men, 7 women) in the PPORP group. The air conduction threshold changed by 22.4 ± 7.5 dB in the SSCG group, and by 13.2 ± 12.9 dB in the PPORP group (p = 0.022), after hearing reconstruction. The air-bone gap (ABG) changed by 20.1 ± 8.3 dB in the SSCG group and by 16.3 ± 12.3 dB in the PPORP group. Although the change in ABG was greater in the SSCG group than in the PPORP group, the difference was not statistically significant (p > 0.05). No complications were recorded in the SSCG group, whereas two patients experienced a severe vertigo attack after surgery in the PPORP group, which lasted for approximately 2 weeks with conservative management. Extrusion was not encountered in the PPORP group, while extrusion of the titanium partial ossicular replacement prosthesis occurred in one patient in the SSCG group who underwent revision surgery., Conclusions: Better hearing outcomes were obtained with SSCG than with PPORP. SSCG can be used as an alternative hearing reconstruction technique in cases of type 3 tympanoplasty.

Objective: The most widely accepted treatment for otosclerosis is currently microscopic stapes surgery under either local or general anesthesia. The aim of the study is to describe the surgical steps in endoscopic stapes surgery and to evaluate the audiologic and surgical outcomes., Materials and Methods: All patients who underwent exclusive endoscopic stapes surgery or revision surgery for previous stapedotomy between November 2014 and September 2018 were enrolled in this study. Demographic data, surgical information, preoperative and postoperative pure tone averages and air bone gaps, intraoperative and postoperative complications and follow-up data were summarized and gathered in a database for further consideration and analysis., Results: In the period examined, 181 stapes surgical procedures were performed and out of these 150 met the inclusion criteria. There were no cases of major intraoperative complications. Sensorineural hearing loss was observed in one case. In one patient a gusher effect occurred during surgery. The postoperative air-bone gap improved significantly compared to the preoperative gap (8 vs 29 dB HL, respectively), and the mean air-bone gap closure was 20 dB HL. In 78.7% of cases, the observed postoperative air-bone gap was less than 10 dB HL and in 14% it was between 11 dB HL and 20 dB HL. An ABG closure lower than 20 dB HL was achieved in a total of 92.7% of patients., Conclusions: Endoscopic stapes surgery is a safe procedure with a low risk of peri- or postoperative complications and is a possible alternative to the traditional microscopic surgical procedure in the treatment of otosclerosis.

Purpose: The primary objective of the retrospective study was to collect speech intelligibility data on children and adolescents implanted with the vibrating ossicular prosthesis (VORP) 503., Methods: This was a retrospective, multicentre study on 55 children and adolescents from 6 German clinics aged between 5 and 17 years suffering from mixed or conductive hearing loss implanted with a VORP 503. Pre- and postoperative bone-conduction pure tone thresholds were measured at 0.5, 1, 2 and 4 kHz, and word recognition scores in the unaided and VORP 503-aided conditions using monosyllabic speech intelligibility tests measured at 65-dB sound pressure level (SPL) were determined., Results: Mean pre- and postoperative bone-conduction thresholds remained unchanged, showing the preservation of inner ear hearing. Speech intelligibility assessed in quiet at 65-dB SPL improved on average from 24.5% (SD ± 25.4) unaided to 86.4% (SD ± 13.4) aided. The average improvement of 61.9% (SD ± 25.3) was clinically and statistically significant. A total of three complications were found in the medical records of 55 subjects. The responsible investigators judged these events as procedure related., Conclusion: The treatment of children suffering from conductive or mixed hearing loss with the VORP 503 implant demonstrates excellent aided benefit in terms of speech understanding and only minor complications.

Objectives: To compare quality-of-life (QoL) measurements with audiological results after stapes surgery with two different prostheses., Methods: This is a retrospective longitudinal study. All patients required stapes surgery for otosclerosis and ossicular chain reconstruction with either a titanium band prothesis (TBP) or receiving a nitinol head prosthesis (NHP). Intervention was between January 2011 and March 2017 patients received stapes-surgery with either TBP (n = 95) or NHP (n = 50). Audiological measurements at three different time points (preoperatively, early follow up < 3 months, late follow-up > 3 months) were compared and two different QoL-inventories, the Glasgow-Benefit-Inventory (GBI) and the Stapes-Plasty-Outcome-Test-25 (SPOT-25) were investigated postoperatively. The main outcome measures were Pure tone average (PTA) at 0.5, 1, 2, 3 kHz at early and late follow up after stapes surgery were compared and correlated with the subjective benefit on the QoL inventories. The perforation method and the type of surgery were analyzed as potentially influencing factors., Results: All patients showed a significantly reduced air bone gap (ABG 0.5, 1, 2, 3) at the two follow-up visits (visit 2: mean: 13.6 dB, SD 7.7; visit 3: mean: 12.7 dB SD 8.1) compared to preoperative measurements (mean: 28.9 dB, SD 9.9) and subjectively benefitted from stapes surgery (mean GBI score: 21.55; SD 20.60, mean SPOT-25 score: 28.03; SD 18.53). The outcome of the two questionnaires correlated with each other. Neither the hearing-outcome nor the subjective benefit was significantly influenced by the prosthesis, the perforation method or the type of anesthesia., Conclusions: Both prostheses were safe and led to comparable hearing results as well as to subjective benefits in the Health-related-Quality-of-Life (HrQoL). A combination of the two questionnaires is recommendable for postoperative quality control.

Introduction: Stapes plasty is an established procedure to improve hearing in case of otosclerosis. By reinforcing the prostheses, an optimization of the prosthesis could be achieved. The aim of the study was to evaluate the audiological results of the Nitinol Superelastic stapes prosthesis compared with a Platin-Teflon prosthesis., Material and Methods: In a retrospecitve setting, the audiological results of nine patients who have been implanted with a Nitinol Alloy Superelastic stapes prothesis were compared with the results of ten patients, which have been implanted with a Platinum-Teflon piston prostesis. All operations were performed by the same experienced ear surgeon., Results: The Nitinol-group presented an average of postoperative air-bone-gap over all frequencies (0.5-6 kHz) of all patients of 15.1 dB. In the Platin-Teflon group, the average of postoperative air-bone-gap was 14.9 dB. Moreover, the post surgery delta-bone-conduction pre- to post surgery showed no differences (0.5-6 kHz). There were no surgical complications in both groups., Conclusion: Based on the patient collective, stapes plasty using a Nitinol Superelastic stapes prosthesis is a sufficient method for improving the hearing conduction., Design: Retrospective case series., Setting: University Department.

Objective: The aim of this study is to perform a systematic literature review on the occurrence of gusher during stapes surgery, to understand its surgical management and outcomes., Methods: The PRISMA standard was applied to identify English, Italian or French-language studies, related to stapes surgery and mentioning gusher or perilymphatic leak. Full-texts lacking information on the management of gusher and/or the post-operative hearing outcome were excluded., Results: Twenty-four articles were eventually included. Seventy-six patients were involved in the qualitative synthesis. The management of gusher mostly consisted in covering the oval window and/or filling the tympanic cavity, with absorbable and autologous graft materials. Packing of the external auditory canal was reported in 51 patients (67%). Gusher was related to complete/profound loss of hearing in 25% of the cases and to a worsening of hearing function in 31% of patients. In 19% of patients an improvement in hearing tests was reported; in 28% the hearing function was unchanged. Post-operative vestibular symptoms were reported in 7 patients, and were mainly mild and transient. The absence of vestibular symptoms was underlined in 9 cases, while in 79% of the patients the authors did not provide information., Conclusion: The unexpected occurrence of gusher during stapes surgery represents a relevant issue for the otologic surgeon. Its management most commonly consists in plugging the oval window and the tympanic cavity. In most of the cases, a stapes prosthesis could be positioned. The results on hearing and vestibular functions are widely variable.

Objective: Chronic otitis media (COM) is an important debilitating public problem causing hearing loss due to irreversible resorption of the ossicular chain. Activation of osteoprotegerin (OPG) during an acute attack of COM prevents bone resorption.The aim of the study was to investigate the role of OPG gene expression level on ossicular chain resorption in chronic otitis media., Materials and Methods: Fifty operated COM patients were included in the study. While 20 patients underwent ossiculoplasty, 30 patients underwent type 1 tympanoplasty. For RNA isolation and OPG gene expression analysis, middle ear swabs were taken from nasopharynx in the ostium of the Eustachian tube. RNA was isolated with mRNA easy kit and kept at - 85 °C till the cDNA and expression analysis. Expression levels were analyzed with real-time quantitative PCR in comparison with PDGB gene expression level as an internal control., Results: Sample Cq measurements of type 1 tympanoplasty group were higher than Cq measurements of the internal control group (p = 0.027; p < 0.05). In contrast, there was no statistically significant difference between sample Cq measurements of ossiculoplasty group and Cq measurements of the internal control group (p = 0.293; p > 0.05)., Conclusion: Since OPG gene expression level was significantly higher in type 1 tympanoplasty group, OPG gene regulation system may have an effect on ossicular chain destruction in COM.

Purpose: Hearing results in revision stapes surgery are largely dependent on the cause of failure, and an appropriate intraoperative diagnosis is crucial for a good outcome. The endoscope allows a detailed exploration of the middle ear cavity and is particularly suitable for the intraoperative assessment of the cause of failure of previous stapes surgery. The present study analyzes the intraoperative findings and outcomes of patients undergoing revision stapes surgery through the endoscopic transcanal approach., Methods: Surgical videos and charts of patients undergoing endoscopic revision stapes surgery from 2008 to 2017 were reviewed retrospectively. Intraoperative findings, difficulties encountered during the surgery and hearing outcomes were evaluated. The feasibility of each surgical step with the totally endoscopic approach or the need for bimanual manipulation was assessed as well., Results: Thirty-four patients were included in the study. The endoscopic transcanal approach allowed a detailed exploration of the middle ear cavity and an accurate intraoperative diagnosis and management of the different causes of failure of the previous surgery. 89.8% of patients achieved an air-bone gap for the PTA ≤ 20 dBHL and 68.5% a closure of the air-bone gap., Conclusions: The present study showed that totally endoscopic revision stapes surgery is a feasible, safe and effective procedure. The transcanal endoscopic approach allowed an accurate intraoperative diagnosis without the need for an endaural or retroauricular approach, with the possibility to manage all the possible intraoperative scenarios. A larger series with a longer follow-up is needed to validate the results.