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IntroductionPatients 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.MethodsThe 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.ResultsThe 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.ConclusionsFunctional 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.

Introduction: In chronic otitis media, the reconstruction of the middle ear's sound conducting system involves repairing the tympanic membrane and filling the space between ossicular chain remnants. The final shape of the prosthesis is usually determined intraoperatively. However, the ossicular chain may be preoperatively measured using computed tomography (CT) scans, and an individualized prosthesis can be designed. Custom 3D printing seems to be an attractive solution for optimal adjustment. Aim: Our study aimed to assess the 3D-printed custom prosthesis movability and compare it to the original ossicular chain. Material and methods: Five fresh-frozen temporal bone specimens were used. Using Cone-Beam CT scans, the incus model was designed individually and 3D-printed. The ossicular chain was reconstructed inside the cadaveric temporal bone. Acoustic stimuli were applied to the external ear canal one frequency at a time. The laser Doppler vibrometer (LDV) measured the intact and 3D-printed prosthesis reconstructed ossicular chain vibrations. Results: At all stimulation frequencies, there was no significant difference in velocity values between the intact and reconstructed ossicular chain at the intensity of 80 dB SPL. The obtained values of the velocity gain were: -7.9 (SD-19) dB, -6.8 (SD- 8.12) dB, -10,9 (SD-5.3) dB, -7.4 (SD-8.16) dB for 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, respectively. The vibration threshold shift values ranged between --0.57 dB at 500 Hz and 3.81 dB at 2000 Hz. Conclusions: This study analyzed the movability of individualized 3D-printed custom ossicular prostheses using LDV. Compared to the intact ossicular chain, the reconstructed ossicular chain movability was characterized by statistically insignificant reduced movability at all tested frequencies. Because the prosthesis's new design conception as custom 3D individualized printing allows for patient-specific ossiculoplasty, it represents a promising new direction for ossicular chain reconstruction. It seems to be an attractive solution for prosthesis optimal adjustment and, hopefully, better hearing results. [ABSTRACT FROM AUTHOR]

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Introduction: In tympanoplasty, surgical reconstruction of the tympanic membrane and ossicular chain is well-established; however, its hearing results still require improvement. Custom 3D printing of individualized ossicular prostheses seems to be an attractive solution for optimal prosthesis adjustment and better hearing results. Aim: The aim was to design a custom ossicular prosthesis using a 3D printing method based on Cone-Beam Computed Tomography (CBCT) scans and assess the acoustic conduction properties of such prosthesis. Material and methods: A cadaver fresh frozen temporal bone was used. Based on CBCT images, a new incus prosthesis was designed and 3D printed. Next, canal wall-up tympanoplasty was performed. The intact ossicular chain and reconstructed 3D-printed prosthesis chain movements/vibrations were measured with Laser Doppler Vibrometer (LDV) system and analyzed in detail. Results: The CBCT scans provided enough information about the anatomical structures. For frequencies 500 and 1000 Hz and 80 dB SPL sound intensity, collected velocities were higher for the intact ossicular chain than the 3D-printed ossicular prosthesis. The intensity thresholds for movement at 500 and 1000 Hz were lower in the intact ossicular chain than in the 3D-printed ossicular prosthesis. At 2000 Hz, there was the same intensity threshold value in the two measured circumstances. Conclusion: It is possible to design a custom individually fitted ossicular prosthesis using a 3D printing method based on CBCT scans. The acoustic conduction properties of such 3D-printed prosthesis showed differences in movability pattern between the intact and reconstructed ossicular chain. More data are needed to analyze the acoustic properties of such designed prostheses in detail. The results of our experiment showed the 3D-printed prosthesis presents the potential to be an interesting option for conductive hearing loss treatment caused by chronic otitis media and the ossicular chain defects. [ABSTRACT FROM AUTHOR]

The Vibrant Soundbridge (VSB) is one of the most widely used implantable hearing devices. It consists of a vibrating floating mass transducer (FMT) that is connected to a middle ear structure. The standard coupling devices for sensorineural hearing loss are short process (SP) or long process (LP) couplers. This study directly compared the electro-mechanical performance of the SP- and LP-coupled FMT of the VSB in the same temporal bone specimen (n = 10). We measured velocity magnitudes and total harmonic distortions (THD) of the stapes (ST) and the round window (RW) using laser Doppler Vibrometry (LDV). Comparison shows a maximally 10 dB higher magnitude for the LP coupler at ST and RW for frequencies below 600 Hz, whereas the SP coupler shows a maximally 20 dB higher magnitude at the ST and RW for frequencies above 600 Hz. THD show similar behaviour with less distortion at 500 Hz for the LP coupler and less distortions for the SP coupler in higher frequencies. Our experiments showed that the SP coupling may be mechanically favourable, in terms of magnitude and distortion, for the transmission of FMT vibrations at higher frequencies. [ABSTRACT FROM AUTHOR]

Abstract Objective We carried out this research to assess and compare post‐stapedotomy hearing results of Matrix titanium prosthesis with a Teflon piston prosthesis, specifically the fluoroplastic (Teflon) Causse loop piston prosthesis in patients who suffered from otosclerosis. Methodology In this retrospective study, Causse loop piston prosthesis was used in 81 ears, and the Matrix prosthesis was applied in 44 ears. For pairwise matching with Matrix prosthesis, 44 out of 81 Causse loop piston‐treated ears were selected based on preoperative audiometric data. Then, postoperative audiometric results of these two groups were compared. The main outcomes were pure tone audiometric results and air‐bone gap (ABG) closure before and after the surgery. Incidence of postoperative sensorineural hearing loss was also evaluated and compared between the two groups. Results The results revealed no significant difference in improvement of speech reception threshold, mean air conduction, bone conduction gain, ABG closure, and incidence of postoperative sensorineural hearing loss at the frequencies of 0.5‐4 kHz between the two groups. However, performance of Matrix prosthesis was better in ABG closure at a frequency of 250 Hz. Conclusion Herein, similar postoperative improvement was achieved at the frequencies of 0.5‐4 kHz; nevertheless, Matrix provided better ABG closure at frequency of 250 Hz in short term. Level of Evidence 4

Objective: To determine differences in failure rate and hearing outcomes of a completely encircling heat-activated crimping prosthesis (SMart 360°) compared to partially encircling prosthesis (SMart)., Study Design: Retrospective chart review., Setting: Private neurotology tertiary referral center., Patients: Patients who underwent stapedotomies performed by the senior authors from 2008 to 2019 using the SMart prosthesis and SMart 360° prothesis., Interventions: Stapedotomy operations with placement of a SMart or SMart 360° prosthesis., Main Outcome Measures: Incidence of early failure requiring revision surgery. Differences in preoperative air-bone gap (ABG) compared to postoperative ABG at 3 months, 1 year, and 2 years after surgery., Results: A total of 228 stapedotomies were performed (SMart n = 48 and SMart 360° n = 180). Mean preoperative ABG for SMart and SMart 360° were 26.15 and 29 dB, respectively. The mean difference in ABG for the SMart at 3 months, 1 year, and 2 years were 17, 18, and 11 dB, respectively. The mean difference in ABG for the SMart 360° at 3 months, 1 year, and 2 years were 20, 20, and 19 dB. ABG differences at 3 months (p = 0.10) and 1 year (p = 0.36) were not statistically different. The failure rate for the SMart prosthesis was 12.5% and for the SMart 360° 2.2% (p = 0.002)., Conclusions: There were no statistically significant differences in ABG changes for SMart compared to SMart 360°. The Smart 360 corrects the problem with early failure seen with the Smart prosthesis., Professional Practice Gap and Educational Need: Determination of most efficacious stapes prosthesis., Learning Objective: Which stapes prosthesis produces better hearing results with fewer failures., Desired Result: To disseminate information necessary to choose the best stapes prosthesis for patients., Level of Evidence: Level III., Indicate Irb or Iacuc: 2022-029-agh., Competing Interests: Conflicts of interest: The authors disclose no conflicts of interest., (Copyright © 2024, Otology & Neurotology, Inc.)

Objectives: This study compares hearing outcomes of two prosthesis materials, bone and titanium, used in ossiculoplasty., Design: This retrospective nationwide registry-based study uses data systematically collected by the Swedish Quality Registry for Ear Surgery (SwedEar)., Setting: The data were obtained from clinics in Sweden that perform ossiculoplasty., Participants: Patients who underwent ossiculoplasty using either bone or titanium prostheses were registered in SwedEar between 2013 and 2019., Main Outcome Measures: Hearing outcome expressed as air-bone gap (ABG) gain., Results: The study found no differences between bone and titanium for ABG or air conduction (AC) for either partial ossicular replacement prostheses (PORP) or total ossicular replacement prostheses (TORP). In a comparison between PORP and TORP for ABG and AC outcomes, regardless of the material used, PORP showed a small advantage, with an additional improvement of 3.3 dB (95% CI [confidence interval], 0.1-4.4) in ABG and 2.2 dB (95% CI, 1.7-4.8) in AC. In secondary surgery using TORP, titanium produced slightly better results for high-frequency pure tone average. The success rate, a postoperative ABG ≤20 dB, was achieved in 62% of the operations for the whole group., Conclusion: Both bone and titanium used to reconstruct the ossicular chain produce similar hearing outcomes for both PORP and TORP procedures. However, titanium may be a preferable option for secondary surgeries involving TORP. The success rate, a postoperative ABG ≤20 dB, is consistent with other studies, but there is room for improvement in patient selection criteria and surgical techniques., (© 2024 The Author(s). Clinical Otolaryngology published by John Wiley & Sons Ltd.)

Objectives: To describe the new semisynthetic total ossicular replacement prosthesis (New-SSTORP) and to evaluate the New-SSTORP ossiculoplasty results both with the presence and absence of the stapes superstructure., Study Design: Prospective study., Setting: Tertiary referral center., Methods: From April 2023 to May 2023, 18 New-SSTORP ossiculoplasties were performed by the first author. In all patients, the New-SSTORP was interposed between the footplate and the eardrum. The study group was divided into two groups (group A and group B). Group A included 13 patients with the absence of stapes superstructure. Group B included five patients with the presence of stapes superstructure. A successful reconstruction was defined as a postoperative air-bone gap ABG ≤20 dB. For all patients of groups A and B, the last audiometric control considered was performed in January 2024. The mean follow-up was 8½ months. The χ2 test was used to compare results. p < 0.05 was considered significant., Main Outcome Measures: Mean postoperative ABG ≤20 dB., Results: At the end of follow-up, the overall success rate (ABG ≤20 dB) of New-SSTORP ossiculoplasty was obtained in 88.8% (n = 16 of 18) of cases. In group A, the success rate of New-SSTORP ossiculoplasty occurred in 84.6% (n = 11 of 13) of cases, and in group B, the success rate of New-SSTORP ossiculoplasty occurred in 100% (n = 5 of 5) of cases. There was no audiological statistically significant difference between groups A and B (Fisher value is 1; p < 0.05). In all cases, the time for positioning of New-SSTORP was about 5 minutes., Conclusion: The New-SSTORP has a minimal technical challenge for building and placement. The New-SSTORP ossiculoplasty results are very good both with the presence and absence of SS., Competing Interests: Sources of support and disclosure of funding: G.M. has patented the shaft prosthesis and does not have funding to disclose. The remaining authors, disclose no conflicts of interest., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of Otology & Neurotology, Inc.)

Objective: To summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss., Materials and Methods: The FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022., Results: Six hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %)., Conclusions: Despite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier Inc.)

Objective: Middle ear surgery involves reconstruction of the ossicular chain, predominately using rigid implants. New middle ear prostheses strive to mimic the physiologic micromovements of the ossicular chain and prevent dislocation, protrusion, and preloading of the annular ligament due to pressure fluctuations., Methods: Thirty-five patients were included in a monocentric, prospective observational study. Patients received tympanoplasty with ossicular reconstruction using the mCLIP ARC partial prosthesis. This titanium prosthesis is equipped with a clip mechanism for coupling at the stapes and a ball joint connecting headplate and shaft. At short-term (ST) and mid-term (MT) follow-up, pure-tone audiometry was performed and the pure tone average of 0.5, 1, 2, and 3 kHz (PTA4) was calculated. The audiological outcome was compared with retrospective data of the Dresden titanium clip prosthesis., Results: The new prosthesis shows favorable clinical results. Pure-tone audiometry showed satisfactory results in ST and MT follow-up, with the PTA4 air-bone gap (ABG) decreasing from 24.5 (±11) dB to 17.4 (±7.9) dB at the ST follow-up at 27 days to 15.6 (±10.3) dB at MT follow-up at 196 days (n = 32). A PTA4-ABG value of less than 20 dB was achieved by 63% of patients at ST follow-up and by 77% at MT follow-up. There was no significant difference in PTA4 ABG compared to the Dresden titanium clip prosthesis during ST follow-up (p = 0.18)., Conclusion: The mCLIP ARC partial prosthesis, a new middle ear prosthesis with a balanced ball joint, shows promising audiological results and is a safe and effective choice for patients with chronic ear disease., Level of Evidence: 3 Laryngoscope, 134:3323-3328, 2024., (© 2024 The Authors. The Laryngoscope published by Wiley Periodicals LLC on behalf of The American Laryngological, Rhinological and Otological Society, Inc.)

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).)

Copyright of HNO is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective: We carried out this research to assess and compare post‐stapedotomy hearing results of Matrix titanium prosthesis with a Teflon piston prosthesis, specifically the fluoroplastic (Teflon) Causse loop piston prosthesis in patients who suffered from otosclerosis. Methodology: In this retrospective study, Causse loop piston prosthesis was used in 81 ears, and the Matrix prosthesis was applied in 44 ears. For pairwise matching with Matrix prosthesis, 44 out of 81 Causse loop piston‐treated ears were selected based on preoperative audiometric data. Then, postoperative audiometric results of these two groups were compared. The main outcomes were pure tone audiometric results and air‐bone gap (ABG) closure before and after the surgery. Incidence of postoperative sensorineural hearing loss was also evaluated and compared between the two groups. Results: The results revealed no significant difference in improvement of speech reception threshold, mean air conduction, bone conduction gain, ABG closure, and incidence of postoperative sensorineural hearing loss at the frequencies of 0.5‐4 kHz between the two groups. However, performance of Matrix prosthesis was better in ABG closure at a frequency of 250 Hz. Conclusion: Herein, similar postoperative improvement was achieved at the frequencies of 0.5‐4 kHz; nevertheless, Matrix provided better ABG closure at frequency of 250 Hz in short term. Level of Evidence: 4 [ABSTRACT FROM AUTHOR]

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).)

Objective: To assess magnetic resonance imaging (MRI) safety of stapes prostheses., Data Sources: Ovid MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science, and Scopus databases were searched from inception to November 2021 following PRISMA guidelines., Review Methods: Studies reporting evidence of stapes prosthesis displacement or interaction in adult or pediatric implant recipients undergoing MRI. Cadaveric, animal, and basic studies with nonhuman data were also included., Results: From an initial search of 123 articles, 42 full-text studies were evaluated for eligibility and 19 studies that met the inclusion criteria were included. Motion artifact was reported in a few stainless steel prosthesis types in vitro; however, such displacement was not observed in human cadaver temporal bone studies and had no adverse reported outcomes. A small subgroup of patients in the 1980s received a ferromagnetic stainless steel stapes implant that was recalled and has not been used since 1987. Patients with implants performed in the 1980s should be directed to 1.5T scanners from an abundance of caution., Conclusion: Modern (post-1987) stapes prostheses do not pose a risk in vivo when exposed to the magnetic fields of MRI scanners., Competing Interests: The authors disclose no conflicts of interest., (Copyright © 2024, Otology & Neurotology, Inc.)

Purpose: To describe the reliability of ultra-high-resolution computed tomography (UHR-CT) in the measurement of titanium stapes prostheses using manufacturer data as a reference., Materials and Methods: This retrospective study included patients treated by stapedectomy with titanium prostheses who underwent UHR-CT between January 2020 and October 2023. Images were acquired using an ultra-high-resolution mode (slice thickness: 0.25 mm; matrix, 1024 × 1024). Two radiologists independently evaluated the length, diameter, and intra-vestibular protrusion of the prosthesis. Post-operative air-bone gaps (ABGs) were recorded., Results: Fourteen patients were enrolled (mean age, 44.3 ± 13.8 [SD] years, 9 females), resulting in 16 temporal bone UHR-CTs. The exact length was obtained in 81.3 % (n = 13/16) and underestimated by 0.1 to 0.3 mm in the remaining 18.7 % (n = 3/16) CT scans for both readers (mean misestimation: -0.02 ± 0.06 [SD] mm, overall underestimation of 0.43 %). The exact diameter was reported in 75 % (n = 12/16) and 87.5 % (n = 14/16) of the CT scans for readers 1 and 2, respectively, and was off by 0.1 mm in all discrepancies (mean misestimation: 0.01 ± 0.04 [SD] mm, overall overestimation of 2.43 %). Intravestibular prosthesis protrusion was of 0.5 ± 0.43 [SD] mm (range: 0-1) and 0.49 ± 0.44 [SD] mm (range: 0-1.1) for readers 1 and 2, respectively, and did not correlate with ABGs (r = 0.25 and 0.22; P = 0.39 and 0.47 for readers 1 and 2, respectively). Intra and interobserver agreements were excellent., Conclusion: UHR-CT provides 99.6 % and 97.6 % accuracy for prosthesis length and diameter measurements, respectively., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Two authors in this work, A.B. and P.A.G.T., are involved in a non-remunerated research contract with Canon Medical Systems., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

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).)

Background: In otosurgical training, cadaveric temporal bones are primarily used to provide a realistic tactile experience. However, using cadaveric temporal bones is challenging due to their limited availability, high cost, and potential for infection. Utilizing current three-dimensional (3D) technologies could overcome the limitations associated with cadaveric bones. This study focused on how a 3D-printed middle ear model can be used in otosurgical training., Methods: A cadaveric temporal bone was imaged using microcomputed tomography (micro-CT) to generate a 3D model of the middle ear. The final model was printed from transparent photopolymers using a laser-based 3D printer (vat photopolymerization), yielding a 3D-printed phantom of the external ear canal and middle ear. The feasibility of this phantom for otosurgical training was evaluated through an ossiculoplasty simulation involving ten otosurgeons and ten otolaryngology-head and neck surgery (ORL-HNS) residents. The participants were tasked with drilling, scooping, and placing a 3D-printed partial ossicular replacement prosthesis (PORP). Following the simulation, a questionnaire was used to collect the participants' opinions and feedback., Results: A transparent photopolymer was deemed suitable for both the middle ear phantom and PORP. The printing procedure was precise, and the anatomical landmarks were recognizable. Based on the evaluations, the phantom had realistic maneuverability, although the haptic feedback during drilling and scooping received some criticism from ORL-HNS residents. Both otosurgeons and ORL-HNS residents were optimistic about the application of these 3D-printed models as training tools., Conclusions: The 3D-printed middle ear phantom and PORP used in this study can be used for low-threshold training in the future. The integration of 3D-printed models in conventional otosurgical training holds significant promise., (© 2024. The Author(s).)

Introduction: Endoscopic ossicular chain reconstruction (OCR) in adults has demonstrated equivalent outcomes to the traditional microscopic approach. Less data exist on endoscopic OCR outcomes in children, who have unique considerations including a smaller transcanal corridor and variable pathology. The purpose of this study was to investigate surgical and audiometric outcomes in children undergoing fully endoscopic and endoscopic-assisted OCR in both the short and long-term., Methods: Retrospective review of all children (<17 years) who underwent endoscopic OCR at one tertiary care center between 2017 and 2021. Children undergoing primary and revision endoscopic OCR with either partial (PORP) and total ossicular reconstruction prostheses (TORP) were included. Children undergoing surgery for juvenile otosclerosis or congenital stapes fixation, or any child receiving a stapes prosthesis were excluded. Primary outcome measures were post-operative change in 4 frequency (500 Hz, 1, 2, 4 KHz) air conduction pure tone average (AC PTA) and change in air-bone gap (ABG). Secondary measures included need for readmission and/or revision surgery, complication rate, and surgery duration., Results: Seventeen patients met inclusion criteria. Average age was 11.3 years (range, 5-17 years); 14 were male. A variety of fixed length, titanium total and partial prostheses were used. The most common prosthesis length was 2 mm (range 2-5 mm), and there were no intra- or perioperative complications. Mean long-term follow-up was 2.6 years. Most common pathology was congenital cholesteatoma (11/17, 64%), followed by chronic otitis media with tympanic membrane perforation (5/17, 29.4%), and extruded prosthesis (1/17, 5.9%). Intraoperatively, the most common finding was incus erosion (10/17, 58.8%), followed by malleus erosion (6/17, 35.3%), stapes erosion (4/17, 23.5%), and stapes absence (4/17, 23.5%). Eight children (47%) were reconstructed with PORPs, and 9 children (52.9%) were reconstructed with TORPs. Average ABG improved from 36.8 dB preoperatively to 19.9 dB postoperatively in the short-term and remained stable at 19.5 dB in the long-term. Average short-term ABG improvement was 4.2 dB for PORPs and 18 dB for TORPs. In the long-term, average ABG improved by 2.3 dB in PORPs and 13.4 dB in TORPs. PORPs had higher rates of ABG closure and lower AC PTAs than TORPs in the long-term., Discussion: Endoscopic ossiculoplasty is a viable option in children presenting with ossicular erosion from various causes. Audiometric improvement following endoscopic partial and total ossicular reconstruction remains stable over time, with a preference towards partial in the long-term, and mirrors published outcomes for microscopic surgery., Competing Interests: Declaration of competing interest Dr. Cosetti is a member of the advisory board of Cochlear Americas. She participates in sponsored research with Cochlear Americas and MedEL. Dr. Cosetti and Dr. Perez are research consultants with Acclarent., (Copyright © 2024 Elsevier B.V. All rights reserved.)

Background: Exploratory tympanotomy in cases of traumatic ossicular disruption with intact tympanic membrane is crucial for both diagnostic and therapeutic purposes. Performing this procedure using the endoscope is gaining popularity. Hence, this study aimed to demonstrate varieties of ossicular pathology and their management in our institution., Methods: A retrospective evaluation was conducted of 136 ears in patients with traumatic ossicular disruption with an intact tympanic membrane, who underwent endoscopic exploratory tympanotomy. A proposed algorithm was followed, to incorporate different traumatic ossicular possibilities. Assessment of hearing outcomes and surgical complications was performed six months post-operatively., Results: Incudostapedial dislocation was the most commonly encountered type of traumatic ossicular disruption (35.3 per cent). Air conduction threshold improved significantly following endoscopic ossiculoplasty, from 50.9 ± 6.35 dB pre-operatively to 22.35 ± 3.27 dB post-operatively, with successful air-bone gap closure., Conclusion: Endoscopic ear surgery is effective in the diagnosis and management of challenging cases of post-traumatic ossicular disruption with an intact tympanic membrane.

BACKGROUND: With the development of modern otological microsurgery, for the lesions involving the ossicular chain, surgeons are required to select appropriate surgical methods to reconstruct the ossicular chain on the basis of thorough removal of the lesions. Titanium ossicular prosthesis becomes an appropriate material for reconstruction of the ossicular chain. OBJECTIVE: To analyze the clinical effect of titanium artificial ossicular prosthesis in one-stage open tympanoplasty for middle ear cholesteatoma. METHODS: This study enrolled 75 middle ear cholesteatoma patients admitted to the First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) from August 2015 to November 2018, including 40 males and 35 females, aged 4-76 years old. All patients underwent mastoidectomy and tympanoplasty. In the first stage of the operation, partial titanium artificial ossicles were implanted in 61 cases and total titanium artificial ossicles were implanted in 14 cases. A thin cartilage perichondrium complex was placed between the tympanic membrane graft and the titanium artificial ossicle. The air, bone conduction threshold, and air bone conduction difference of 75 patients before and 6 months after the operation were compared to evaluate the hearing recovery after the operation. This study was approved by the First Affiliated Hospital of University of Science and Technology of China. RESULTS AND CONCLUSION: (1) The follow-up time of all cases was ≥ 6 months. The outcome of dry ear was achieved about 4-6 weeks. At 6 and 12 months after the operation, the otoscope observation showed that the mastoid cavity was well epithelialized, the tympanic cavity was full of air, and the external auditory meatus was spacious and unobstructed. Totally 71 cases of tympanic membrane transplantation healed at the first stage, 3 cases of artificial ossicles were partially prolapsed, and 3 cases of ossicles were completely lost. (2) At 6 months after operation, the air conduction hearing threshold of 75 patients was lower than before operation (P < 0.05). There was no significant difference between bone conduction threshold and preoperative comparison (P > 0.05). (3) The results showed that the one-stage reconstruction of ossicular chain with titanium artificial ossicles on the basis of debridement of lesions in open tympanoplasty can achieve satisfactory hearing effect, with fewer postoperative complications and lower rejection reaction, which is a better optimal treatment option. [ABSTRACT FROM AUTHOR]

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Introduction Autologous reshaped Incus and Teflon partial ossicular replacement prosthesis (PORP) are commonly used for ossicular chain reconstruction. The present study attempts to assess the post-operative outcome with these two prostheses. Materials and Methods A Randomized prospective study was conducted in Tertiary referral care hospital to determine which material, among autologous reshaped Incus and Teflon partial ossicular replacement prosthesis (PORP) gives better postoperative hearing result in Ossiculoplasty. Patients presenting at outpatients’ department with the clinical diagnosis of chronic otitis media with perforation or retraction. The study population consisted of a total of 50 patients. Ossiculoplasty with reshaped Incus or PORP was performed after Canal Wall Up mastoidectomy. Hearing results were measured by Air-Bone gap in PTA after 6 months of surgery. Results Selecting the criteria

Objectives: To report an extremely rare case of malleoincudal osteoma that led to conductive hearing loss despite an unusually normal otomicroscopic appearance, and to highlight the usefulness of costal cartilage for ossicular chain reconstruction after tumour removal. Case report: A 37-year-old woman presented with a 2-year history of progressive, right-sided hearing loss. Physical examination revealed a normal tympanic membrane. Pure tone audiometry showed a right-sided conductive hearing loss. High-resolution computed tomography revealed a right-sided epitympanic mass arising from the malleus head and contiguous with the incus. The patient underwent a closed mastoido-epitympanectomy. The malleus head and the incus with associated malleoincudal osteoma were removed. Ossicular chain reconstruction using costal cartilage was performed at the time of tumour removal. Conclusion: The possibility of a middle-ear osteoma must be considered in cases of unilateral and progressive conductive hearing loss with a normal otomicroscopic appearance in patients with no history of ear infection, trauma or prior surgery, and with no family history of hearing loss. Surgical treatment is indicated in cases of significant conductive hearing loss. To our knowledge, this is the first case report of malleoincudal osteoma in which the ossicular chain was reconstructed using costal cartilage. [ABSTRACT FROM AUTHOR]

The purpose of this study was to examine the quality of life (QoL) and hearing thresholds of patients who underwent 2 types of stapes surgery. A retrospective cohort study was performed comparing stapedotomy with NiTiBOND prostheses (n=20) and stapedectomy with autogenous cortical bone columella (n=20), applying the Glasgow Benefit Inventory (GBI) and the Hearing Handicap Inventory for Adults outcome measures with hearing thresholds. Univariate comparative statistical methods were applied. The stapedotomy cohort had significantly better values of Social Support Score of the GBI as compared to the stapedectomy cohort (P=.016). No statistically significant difference was detected between the groups in the pre- and postoperative audiological results and the further QoL measures. Apart from the excellent postoperative audiological results of the different types of stapes surgeries, stapedotomy with NiTiBOND prostheses seems to be superior as regards QoL over stapedectomy applying autogenous cortical bone columella.

This study investigates the performance of personalised middle ear prostheses under static pressure through a combined approach of numerical analysis and experimental validation. The sound transmission performances of both normal and reconstructed middle ears undergo changes under high positive or negative pressure within the middle ear cavity. This pressure fluctuation has the potential to result in prosthesis displacement/extrusion in patients. To optimise the design of middle ear prostheses, it is crucial to consider various factors, including the condition of the middle ear cavity in which the prosthesis is placed. The integration of computational modelling techniques with non-invasive imaging modalities has demonstrated significant promise and distinct prospects in middle ear surgery. In this study, we assessed the efficacy of Finite Element (FE) analysis in modelling the responses of both normal and reconstructed middle ears to elevated static pressure within the ear canal. The FE model underwent validation using experimental data derived from human cadaveric temporal bones before progressing to subsequent investigations. Afterwards, we assessed stapes and umbo displacements in the reconstructed middle ear under static pressure, with either a columella-type prosthesis or a prosthetic incus, closely resembling a healthy incus. Results indicated the superior performance of the prosthetic incus in terms of both sound transmission to the inner ear and stress distribution patterns on the TM, potentially lowering the risk of prosthesis displacement/extrusion. This study underscores the potential of computational analysis in middle ear surgery, encompassing aspects such as prosthesis design, predicting outcomes in ossicular chain reconstruction (OCR), and mitigating experimental costs., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Ltd.)

Objective: Investigating the outcomes of a surgical approach to treat isolated defects of the stapes suprastructure, using a modified total ossicular replacement prosthesis (TORP) prosthesis as a PORP between the footplate and the incus, effectively creating a TORP-PORP configuration., Patients: Eleven patients (mean age, 37.2 years; 36% male and 64% female) between the years 2007 and 2022., Interventions: Therapeutic (ossiculoplasty)., Main Outcome Measures: Hearing gain (in dB) in air conduction thresholds at 0.5, 1, 2, 3, and 4 kHz, stability of bone conduction, revision rate., Results: Significant improvement in air conduction between the preoperative and the postoperative cohorts (p = 0.002) with a mean postoperative hearing level of 30.00 ± 5.25 dB. The bone conduction remained stable. We encountered no perioperative complications, and there were no revisions surgery., Conclusions: The described ossiculoplasty procedure is a safe and effective approach to treat isolated defects of the stapes suprastructure., (Copyright © 2024, Otology & Neurotology, Inc.)

&lt;b&gt;&lt;br&gt;Introduction:&lt;/b&gt; In chronic otitis media, the reconstruction of the middle ear&apos;s sound conducting system involves repairing the tympanic membrane and filling the space between ossicular chain remnants. The final shape of the prosthesis is usually determined intraoperatively. However, the ossicular chain may be preoperatively measured using computed tomography (CT) scans, and an individualized prosthesis can be designed. Custom 3D printing seems to be an attractive solution for optimal adjustment.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Aim:&lt;/b&gt; Our study aimed to assess the 3D-printed custom prosthesis movability and compare it to the original ossicular chain.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Material and methods:&lt;/b&gt; Five fresh-frozen temporal bone specimens were used. Using Cone-Beam CT scans, the incus model was designed individually and 3D-printed. The ossicular chain was reconstructed inside the cadaveric temporal bone. Acoustic stimuli were applied to the external ear canal one frequency at a time. The laser Doppler vibrometer (LDV) measured the intact and 3D-printed prosthesis reconstructed ossicular chain vibrations.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Results:&lt;/b&gt; At all stimulation frequencies, there was no significant difference in velocity values between the intact and reconstructed ossicular chain at the intensity of 80 dB SPL. The obtained values of the velocity gain were: -7.9 (SD-19) dB, -6.8 (SD8.12) dB, -10,9 (SD-5.3) dB, -7.4 (SD-8.16) dB for 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz, respectively. The vibration threshold shift values ranged between -0.57 dB at 500 Hz and 3.81 dB at 2000 Hz.&lt;/br&gt; &lt;b&gt;&lt;br&gt;Conclusions:&lt;/b&gt; This study analyzed the movability of individualized 3D-printed custom ossicular prostheses using LDV. Compared to the intact ossicular chain, the reconstructed ossicular chain movability was characterized by statistically insignificant reduced movability at all tested frequencies. Because the prosthesis&apos;s new design conception as custom 3D individualized printing allows for patient-specific ossiculoplasty, it represents a promising new direction for ossicular chain reconstruction. It seems to be an attractive solution for prosthesis optimal adjustment and, hopefully, better hearing results.&lt;/br&gt.

Background: Numerous studies have been conducted on the effect of the stapes superstructure after ossicular chain reconstruction, but the findings are not uniform., Objective: To compare the hearing outcomes of ossicular chain reconstruction with partial ossicular replacement prosthesis (PORP) or total ossicular replacement prosthesis (TORP) under otoendoscopy., Materials and Methods: The records of 111 patients diagnosed with chronic suppurative otitis media were retrospectively analyzed. These patients were divided into PORP group ( n  = 57) and TORP group ( n  = 54). They were further subdivided into subgroups PORP-a (with a malleus handle) and PORP-b (without a malleus handle), subgroups TORP-a and TORP-b. Pre- and postoperative audiometric results were analyzed., Results: The mean postoperative air conduction hearing thresholds improvement, mean air-bone gap improvement, and the success rate of reconstruction were significantly higher in the PORP group than in the TORP group ( p  < .05). The mean postoperative air conduction hearing thresholds improvement and the success rate of reconstruction were significantly higher in the PORP-a group than in the TORP-a group ( p  < .05); and similar results were concluded in comparison of the PORP-b group and the TORP-b group., Conclusions and Significance: The stapes superstructure has an important positive effect on the postoperative outcome of endoscopic ossicular chain reconstruction.

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).)

The utilization of endoscopes in modern otology has evolved from diagnostic purposes to the development of exclusive endoscopic ear surgery. This technique offers a panoramic view of the middle ear and provides an optimal magnification of the oval window region, the stapes' suprastructure, and the footplate, allowing great precision in prosthesis positioning during ossiculoplasty (OPL). Various techniques for ossicular chain reconstruction have been described in the literature. Either autologous or synthetic materials can be used for reconstruction. The use of a patient's own tissue minimizes the risk of implant rejection or extrusion of the prosthesis through the tympanic membrane. On the other hand, synthetic materials like titanium are light and rigid and do not require time-consuming prosthesis remodeling. The main objective of this article is to present a comprehensive step-by-step guide that serves as a surgical manual for exclusive endoscopic OPL. This guide will explain various forms of OPL using synthetic and autologous materials. The goal is to provide a comprehensive understanding of the various surgical techniques and support the integration into clinical practice.

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).)

Introduction: Congenital ossicular chain anomalies are rare conductive hearing loss conditions that remain difficult to diagnose even with high-resolution computed tomography (CT). The preoperative diagnosis is helpful for surgical planning and counseling patients regarding treatment outcomes., Case Presentation: We report a case involving a 14-year-old boy presenting with left conductive hearing loss without history of trauma for 5 years, physical examination showed normal otoscopic examination bilaterally and high-resolution CT showed absent of stapes suprastructure and footplate. Subsequent diagnosis was done via endoscopic middle ear exploration which revealed an absent long process of the incus, stapes suprastructure and footplate, but with intact oval window membrane. The residual incus was removed, and a tragal perichondrium graft was used over the oval window. A total ossicular replacement prosthesis was placed between the malleus and oval window to repair the chain. Postoperatively, the patient had no complications. Preoperative pure tone average revealed an air/bone result of 52/8 dB. Follow-up after surgery at 6 months showed a pure tone average air/bone result of 15/3 dB. The air-bone gap was reduced from 44 to 12 dB., Conclusion: Congenital absence of the stapes suprastructure and footplate remains a rare condition compared to the myriad of middle ear anomalies in the literature., (© 2024 S. Karger AG, Basel.)

This study investigated sound localization abilities in patients with bilateral conductive and/or mixed hearing loss (BCHL) when listening with either one or two middle ear implants (MEIs). Sound localization was measured by asking patients to point as quickly and accurately as possible with a head-mounted LED in the perceived sound direction. Loudspeakers, positioned around the listener within a range of +73°/-73° in the horizontal plane, were not visible to the patients. Broadband (500 Hz-20 kHz) noise bursts (150 ms), roved over a 20-dB range in 10 dB steps was presented. MEIs stimulate the ipsilateral cochlea only and therefore the localization response was not affected by crosstalk. Sound localization was better with bilateral MEIs compared with the unilateral left and unilateral right conditions. Good sound localization performance was found in the bilaterally aided hearing condition in four patients. In two patients, localization abilities equaled normal hearing performance. Interestingly, in the unaided condition, when both devices were turned off, subjects could still localize the stimuli presented at the highest sound level. Comparison with data of patients implanted bilaterally with bone-conduction devices, demonstrated that localization abilities with MEIs were superior. The measurements demonstrate that patients with BCHL, using remnant binaural cues in the unaided condition, are able to process binaural cues when listening with bilateral MEIs. We conclude that implantation with two MEIs, each stimulating only the ipsilateral cochlea, without crosstalk to the contralateral cochlea, can result in good sound localization abilities, and that this topic needs further investigation., Competing Interests: Declaration of Conflicting InterestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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).)

Objectives: To investigate the etiology and ossicular pathology of traumatic ossicular injury in Taiwan and examine the hearing outcomes and predictive factors between the titanium prosthesis and autologous incus groups., Methods: We retrospectively analyzed patients with traumatic ossicular injury from 2011 to 2020 in Taiwan. Patients were divided into the titanium or autologous group according to the surgical materials used. The audiometric outcomes and predictive factors of ossiculoplasty were analyzed between groups., Results: Twenty patients with ossicular chain discontinuity were enrolled (8 in the titanium group and 12 in the autologous group). The postoperative hearing threshold (26.6 ± 8.9 dB) and air-bone gap (10.3 ± 5.6 dB) improved significantly compared with the preoperative hearing threshold (50.7 ± 13.3 dB) and air-bone gap (29.9 ± 11.0 dB). The improvements in the hearing threshold and air-bone gap were not significantly different between the titanium and autologous groups. Our patients presented an improvement in hearing restoration with 65% closure of the air-bone gap in 0 to 10 dB range and 30% in 11 to 20 dB range, without sensorineural hearing loss during surgery. Univariate regression analysis revealed that vertigo, benign paroxysmal positional vertigo, and temporal bone fracture may serve as negative factors influencing the air-bone gap gain., Conclusions: Ossiculoplasty with both titanium prosthesis and autologous materials demonstrated favorable hearing recovery in traumatic ossicular injury. Vertigo, benign paroxysmal positional vertigo, and temporal bone fracture may serve as negative predictive factors of the hearing benefit after surgery., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Objective: To investigate the surgical approach and the audiological outcome of a stapes head coupler in active middle ear implant surgery., Study Design: Retrospective data analysis., Setting: Tertiary referral center with a large active middle ear implant program., Patients: Twelve patients with active middle ear implant surgery., Interventions: Therapeutic surgical approach for hearing rehabilitation in human subjects., Main Outcome Measures: Auditory brainstem response, sound field thresholds, vibrogram, speech perception in the Freiburger monosyllabic word test., Results: The stapes head was attached safely in different coupling situations. Audiological outcomes were similar to the audiological performance of established vibroplasty couplers presented in the literature., Conclusion: The stapes head coupler is a new and safe tool for vibroplasty with a good audiological outcome., Competing Interests: Conflicts of interest: The authors disclose no conflicts of interest., (Copyright © 2023, Otology & Neurotology, Inc.)

Objectives: To review the decision-making paradigm in the recommendations of BCI and aMEI overlapping candidacy for patients with conductive or mixed HL, and to determine if there are differences in hearing and quality of life outcomes between these implantable hearing devices., Methods: Retrospective data from patients receiving BCI or aMEI in the past decade were analysed. Patients were grouped into: 1. BCI candidates, 2. BCI or aMEI candidates, and 3. aMEI candidates. We compared outcomes and examined the impact of BC threshold, age at implantation, and duration of hearing loss on candidacy., Results: 89 participants were included: 30 BCI, 37 aMEI, and 22 BCI or aMEI candidates. All groups performed similarly in aided sound field threshold testing. BCI group had lower speech scores in quiet compared to 'BCI or aMEI.' No significant differences were found in APHAB global scores. BC threshold, duration of hearing loss, and age at implantation had no significant effects., Discussion: Outcomes were generally similar across groups, except for higher effective gain in the aMEI group., Conclusion: Our proposed patient pathway and decision-making approach facilitate candidate selection for aMEI and BCI, aiming to optimise outcomes.

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.)

Objective:The aim of this study was to investigate functional results of total ossicular replacement prosthesis (TORP) shaft stabilization with a cartilage shoe in chronic otitis media patients with cholesteatoma who had undergone canal wall down tympanomastoidectomy (CWDT). In addition, it was determined whether the presence of granular and edematous mucosa in middle ear altered functional outcomes.Methods: Sixty patients, who had undergone CWDT with the use of TORP for the reconstruction of ossicular chain, were divided into two groups. Patients with cartilage shoe were classified as Group 1 (n=30) and those without the shoe were classified as Group 2 (n=30). Patients in both groups were classified into “A” and “B” subgroups according to the middle ear risk index (MERI). Air conduction (AC) and bone conduction thresholds were evaluated preoperatively and postoperatively.Results: There was no statistically significant change between preoperative AC thresholds of the groups and subgroups (p>0.05). There were statistically significant differences regarding AC thresholds and air– bone gap (ABG) values between Groups 1 and 2 at the postoperative 12th month (p

Objective: The objective of this study is to describe the clinical features, managements and outcomes of a rare coexistence of congenital ossicular anomaly and localized cholesteatoma. A literature review on these cases and each congenital disorder is also presented.Methods: A retrospective chart review was performed on patients diagnosed with congenital ossicular anomaly with concurrent localized cholesteatoma from 2008 to 2017. Clinical data of these patients were collected.Results: A total of 10 patients were identified. All patients presented with unilateral hearing loss. Pure-tone audiometry showed conductive hearing loss in all affected ears with an average air conduction (AC) threshold of 59 dB. High-resolution computed tomography scans of the temporal bone diagnosed ossicular anomaly for 90% (9/10); however, only 50% (5/10) had a diagnosis of localized cholesteatoma. A transcanal exploratory tympanotomy under the microscope was performed to discover whether the localized tiny-sized cholesteatoma around the ossicular chain did not have direct contact with the ossicular chain, which could be diagnosed as congenital cholesteatoma. We removed the localized cholesteatoma and reconstructed the ossicular chain in each patient. All localized cholesteatomas were found in the posterior-superior quadrant of the middle ear. Ossicular chain anomalies were associated with the incus and/or the stapes in all cases. Hearing improvement was achieved in each of the 6 patients who were followed up postoperatively, with an average AC threshold of 35 dB. The clinical features of congenital ossicular anomaly with concurrent congenital cholesteatoma were compared with those of each congenital disorder. The pathogenesis of each condition was also discussed.Conclusions: Congenital ossicular anomaly with concurrent congenital cholesteatoma is rare. It shares similar clinical features with congenital ossicular anomaly occurring alone, therefore awareness should be raised for a possible concurrent congenital cholesteatoma which was easy to miss in the diagnosis (50%) by the radiologist. A patient's hearing level can be improved by removal of the cholesteatoma and reconstruction of the ossicular chain. Localized cholesteatoma does not usually show residuals or recurrence. [ABSTRACT FROM AUTHOR]

Abstract Background Conductive hearing loss due to ossicular abnormalities occurs from many causes, including trauma, infection, cholesteatoma, surgery and congenital anomalies. Surgical reconstruction of the ossicular chain is a well-established procedure for repair of ossicular defects, but is still plagued by high failure rates. Underlying disease and proper sizing of prostheses are two challenges that lead to component failure. Three-dimensional (3D) printing has been used successfully to solve a number of medical prosthesis problems. Custom 3D printing an individualized ossicular prosthesis would be a potential solution for the wide range of anatomic variation encountered in the pathological middle ear, and could decrease the rate of post-operative prosthesis displacement by increasing the likelihood of a proper fit, in addition to decreasing surgical time. In this study, the incus was removed from three formalin-fixed cadaveric human temporal bones with no macro- or microscopic evidence of pathology. Imaging of the cadaveric bone was obtained using a standard temporal bone CT protocol. A custom prosthesis for each cadaveric human temporal bone was designed using the Mimics Innovation Suite software (Materialise, Belgium) and fabricated on a Form2 3D printer (FormLabs, Somerville, Massachusetts). Four surgeons then performed insertion of each prosthesis into each middle ear, blinded to the bone from and for which each was designed. The surgeons were asked to match each prosthesis to its correct parent bone. Results Each prosthesis had unique measurements. Each of the four surgeons was able to correctly match the prosthesis model to its intended temporal bone. The chances of this occurring randomly are 1:1296. Conclusions A custom 3D printed ossicular prosthesis is a viable solution for conductive hearing loss due to ossicular chain defects. Commercially available CT scanners can detect significant anatomic differences in normal human middle ear ossicles. These differences can be accurately represented with current 3D printing technology and, more significantly, surgeons can detect these differences.