Long-term outcomes following pediatric endoscopic titanium ossiculoplasty: A single-institution experience.

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.

Integration of 3D-printed middle ear models and middle ear prostheses in otosurgical training.

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.

Ultra-high-resolution CT of the temporal bone: The end of stapes prosthesis dimensional error and correlation with patient symptoms.

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.

MRI Safety of Stapes Prostheses: A Systematic Review.

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.

Analysis of the effect of reconstructing the ossicular chain under otoendoscopy with and without a stapes superstructure.

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.

The TORP-PORP: A Tympanoplasty Technique for Isolated Defects of the Stapes Suprastructure.

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.

Techniques of Endoscopic Ossiculoplasty.

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.

Performance of personalised prosthesis under static pressure: Numerical analysis and experimental validation.

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.

The effect of piston diameter in primary stapes surgery on surgical success.

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.

A novel coupling quality index to estimate the coupling efficiency in Vibrant Soundbridge.

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.

Endoscopic ossiculoplasty in traumatic conductive hearing loss with intact tympanic membrane: a five-year experience.

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.

Long term results of glass ionomer ossiculoplasty.

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.

Long-term results and quality of life after vibrant soundbridge implantation (VSBs) in children and adults with aural atresia.

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.

Predictive Factors and Audiometric Outcome Comparison Between Titanium Prosthesis and Autologous Incus in Traumatic Ossicular Injury.

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.

The influence of intraoperative auditory brainstem responses on vibroplasty coupling-quality and analysis of the impact of different fixation steps on the coupling.

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; η2 = 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.

Reconstructive ossiculoplasty options in primary cholesteatoma surgeries with an intact stapes.

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.

Recommendations for post-rehabilitation care of maxillofacial prostheses

Aim: This study aimed to review the scientific literature to describe the main care and hygiene protocols for different types of maxillofacial prostheses (MFP). Methods: A bibliographic search on the PubMed / Medline database using the following keywords: ["maxillofacial prosthesis" OR "ocular prostheses" OR "palatal obturators"] AND ["Cleaning" OR "disinfection"] AND ["care"] AND ["color stability"] OR ["denture cleansers" OR "cleansing agents"]. Articles addressing materials, cleaning and disinfection protocols, and care related to MFP were included. The following exclusion criteria were applied: no adequate methodology, incompatibility with the area of interest, and unavailability for reading in full. Results: The papers were grouped into the following topics: facial prostheses, ocular prostheses, maxillofacial intraoral prostheses, and retention systems. Conclusion: Despite the MFP changes over time, its degradation decreases upon following the recommendations and post-adaptation care. The guidelines for cleaning and disinfection must be individualized to guarantee the longevity of the prosthesis and the patient health

The Stapes Head Coupler-A Flexible and Safe Option for Vibroplasty.

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.

Short-term safety and effectiveness of the mCLIP partial prosthesis.

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 (PTA4). The post-operative PTA4 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 PTA4 ABG of ≤ 20 dB. Individual post-operative bone conduction (BC) PTA4 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 PTA4 ABG of ≤ 20 dB. None of the children reported a BC PTA4 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.

[Discussion of Application Status and Key Attentions on Registration for Ossicular Replacement Prosthesis].

The ossicular replacement prosthesis should have good biocompatibility, stability, easy to install, and excellent sound transmission capacity. In this study, the characteristics of ideal materials for the ossicular replacement prosthesis were analyzed by searching the types of materials used in clinical practice and comparing the advantages and disadvantages of various materials and structures. At the same time, in combination with the current evaluation requirements and evaluation experience, the focus of the performance research project of ossicular replacement prosthesis in the process of registration is discussed to clarify the performance evaluation requirements of these products, so as to provide reference for the future work of manufacturers and regulators. The performance evaluation of ossicular replacement prosthesis focuses on its mechanical properties, fixation stability, sound transmission characteristics, biological characteristics, and magnetic resonance compatibility.