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Background Stapes surgery success depends on several factors, including the length of the prosthesis used. Whether to use a standard-size prosthesis or measure the length of the stapes prosthesis has been debated in the literature. This study aims to assess the surgical outcomes of a stapedotomy using the standard 4.5 mm prosthesis without custom measurements. Methodology This retrospective study involved patients with otosclerosis who underwent primary stapedotomy using a standardized 4.5 mm fixed-length prosthesis between January 2017 and February 2023 at a tertiary care center. Results Out of 111 charts reviewed, 99 ears (56 males and 43 females) were studied. The mean air-bone gap (ABG) significantly improved from 27.9 ± 9.12 dB preoperatively to 3.95 ± 3.54 dB post-operatively (p-value < 0.05). Hearing results showed that out of 99 ears, 96.96% had a postoperative ABG of ≤10 dB and 98.98% ≤20 dB. Only three patients showed postoperative mild transient dizziness that lasted a few days. None of the patients had persistent dizziness for more than one week. One patient developed postoperative reparative granuloma with tinnitus and sensory-neural hearing loss. None had a recurrence of the conductive hearing loss during the study period. Conclusion Our retrospective study on stapes surgery utilizing a standardized 4.5 mm prosthesis without custom measurements showed notable surgical success and safety. Using a standard-size prosthesis shortens the surgical time and eliminates the complexities associated with intraoperative measurements, potentially reducing the risk of complications.

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BACKGROUND/OBJECTIVES: Otosclerosis is a relatively uncommon condition that causes conductive hearing loss in children. The preferred treatment for adults is stapedotomy, while for individuals under 18 years old, there is an ongoing discussion about the best treatment approach. Thus, the surgical procedure for the stapes in pediatric patients continues to be a subject of debate. This study aimed to evaluate the results of stapes surgery in children, trying to understand, based on our results, whether this is actually the most suitable option. METHODS: The study included 18 patients who underwent surgery between January 2013 and December 2023. The patients' ages ranged from 11 to 18 years, with an average age of 14.7. Out of the total 21 surgeries, three patients opted for bilateral surgery. Pre- and post-operative data were compared, focusing on the mean air conduction (AC) and bone conduction (BC) thresholds at frequencies of 0.5, 1, 2, and 4 kHz. Additionally, pre-operative thresholds and the post-operative air-bone gap (ABG) were examined. RESULTS: After a year, the air-bone gap was effectively reduced to 10 dB or less in 94% of the 21 cases, and to 20 dB or less in 98% of all cases. CONCLUSIONS: Our results and research in the field have consistently shown that stapedotomy, when conducted by skilled otosurgeons, is a reliable and successful procedure for a considerable number of patients. The outcomes it generates are similar to those achieved through the procedure conducted during adulthood.

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PURPOSE: This study aimed to conduct a comparative analysis of audiological and postoperative clinical outcomes between the endoscopic and microscopic stapedotomy approaches. METHODS: This study employed a randomized, controlled design. Twenty-seven patients with bilateral otosclerosis underwent stapedotomy in both ears, with randomized allocation of the surgical technique (endoscopic vs. microscopic) for the first operated ear. Air-bone gap (ABG) and ABG gain were measured at least 12 months postoperatively. Postoperative outcomes including pain (Visual Analog Scale-VAS), dizziness, early-term (day 1) and late-term (6 months) dysgeusia were evaluated. The Glasgow Benefit Inventory (GBI) assessed health-related quality of life at one month postoperatively, and operative time was measured. RESULTS: This study compared endoscopic (n = 27 ears) and microscopic (n = 27 ears) stapedotomy for otosclerosis. Both groups achieved similar hearing improvement with no significant differences in pre-operative and post-operative bone/air conduction thresholds, ABG, and ABG gain (all p > 0.05). The endoscopic stapedotomy group demonstrated reduced postoperative pain (lower VAS scores, p < 0.001), lower early dysgeusia (3.7% vs. 33.3%, p = 0.005), shorter operative time (47.3 vs. 75.4 min, p < 0.001) and improved patient-reported outcomes (higher GBI score, p = 0.014) when compared to microscopic stapedotomy group. No significant differences were observed in postoperative dizziness or late-term dysgeusia between groups. CONCLUSION: This study found similar hearing improvement with both endoscopic and microscopic stapedotomy for otosclerosis. However, the endoscopic approach showed advantages in reduced postoperative pain, early dysgeusia, and operative time, with improved patient-reported quality of life. These findings suggest endoscopic stapedotomy as a valuable alternative to the conventional microscopic approach.

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PURPOSE: Otosclerosis leads to a fixed stapes footplate and thus to hearing loss. The predominant treatment method is surgery, with various types of stapes prostheses available. The aim of this study was to investigate the safety and efficacy of the new mAXIS Stapes Prosthesis. METHODS: 34 cases of otosclerosis were implanted with the new mAXIS Stapes Prosthesis. Comprehensive clinical assessments, including pre- and postoperative pure tone audiometry was performed at short-term (ST) follow-up at 25 (± 15) days and mid-term (MT) follow-up at 181 (± 107) days. The pure tone average of 0.5, 1, 2 and 3 kHz (PTA4) was calculated. RESULTS: In all cases, the application of the prosthesis was successful and straightforward. The postoperative PTA4 air-bone gap was 10.7 ± 5.2 dB at ST follow-up (n = 34) and 8.3 ± 4.1 dB at MT follow-up (n = 18). In 61% of cases, the ABG-closure was within 10 dB and in 100% of cases within 20 dB at MT follow-up. CONCLUSION: Findings of this study support that the mAXIS Stapes Prosthesis is safe for implantation and shows promising audiological outcome. Future investigations will contribute its long-term efficacy and safety profile.

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BACKGROUND: Enlarged vestibular aqueduct (EVA) syndrome can mimic otosclerosis in adults, presenting with an air-bone gap (ABG) and even absent stapedial reflexes. The ABG in inner-ear disorders is currently the object of several authors' studies and seems to be related to a third mobile window (TMW) phenomenon. This can lead to misdiagnosis and inappropriate treatment. Given that it would be inappropriate and harmful to perform CT scans in all patients with a clinical diagnosis of otosclerosis, this study aims to highlight some clinical features useful for the differential diagnosis between otosclerosis and these rare cases of EVA presenting with an ABG, thus enabling the identification of suspected cases to be tested with CT scans. METHODS: Between April and May 2024, a narrative review was conducted focusing on the differential diagnosis between some rare cases of EVA and otosclerosis. Clinical, audiological, and radiologic features of both conditions were investigated. RESULTS: This review demonstrates the diagnostic challenge in differentiating atypical cases of EVA from otosclerosis in a subset of patients. Clinical and audiological features are important for differential diagnosis, but may not always be sufficient. Therefore, high-resolution computed tomography (HRCT) of the temporal bone plays a pivotal role in definitive diagnosis. CONCLUSIONS: In some specific cases, pre-operative imaging assessment using HRCT emerges as an essential tool for differentiating these two conditions and avoiding unnecessary stapes surgery.

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PURPOSE: Revision stapes surgery is a challenging procedure performed in relatively small numbers compared to other middle ear procedures. Despite numerous data on hearing results of different middle ear surgeries, the audiological standards for successful outcome of this procedure are still not clarified. On the basis of well-documented data, we wanted to determine what the expected audiological results and complications are after revision stapes surgery in order to set a realistic threshold for surgical success. METHODS: After the protocol registration in the PROSPERO database, a systematic review was performed in multiple databases (PubMed, Cochrane, Web of Science, Scopus, ScienceOpen, ClinicalTrials.gov, Google Scholar) according to PRISMA guidelines. Twelve articles were reviewed according to the inclusion criteria. A total of 1032 cases were obtained for evaluation. A modified version of Newcastle-Ottawa Scale (NOS) was used to assess publication quality. RESULTS: Average air-bone gap (ABG) gain was 17.3 dB, average air conduction (AC) gain was 17.5 dB. The average postoperative air-bone gap was 11.1 dB. The postoperative ABG distribution was the following 0-10 dB: 53.3%, > 10-20 dB: 28.2%, > 20 dB: 18.5%. SNHL as a surgical complication was described in a total of 17 cases (1.6%), no equilibrium disorder was reported. CONCLUSION: The pooled data suggest that revision stapes surgery is an effective solution after failure of previous stapes surgery. However, the results are clearly inferior to those of primary stapedotomies. Hence, we need to apply different expectations and use different standards in the indication and evaluation of this type of surgery.

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Objectives: This study aims to evaluate and compare the surgical outcomes of endoscopic malleostapedotomy (EMS) and endoscopic incudostapedotomy (EIS). Methods: A retrospective analysis was conducted on 36 consecutive ears in 33 patients who underwent stapes surgery using either EMS (EMS group) or EIS (EIS group). Operational practicability across surgical steps, postoperative hearing, operation time, switch of approach, and complications were compared between the two groups. Results: The EMS and EIS groups comprised seven (19.4%) and 29 ears (80.6%), respectively. The EMS group exhibited a greater proportion of moderate practicability in anchoring site exposure (42.9%, three of seven) and in securing the prosthesis (100%, seven of seven) in comparison to the EIS group, which had 0% (0 out of 29) and 41.4% (12 out of 29), respectively. Postoperative hearing improvements were equivalent between the groups, with EMS achieving a mean air-bone gap improvement of 28.8 dB and EIS of 23.2 dB. The ABG closure rates within 10 dB and 20 dB for the EMS group were 28.6% and 100%, respectively, and not significantly different from the EIS group (p = .103). However, the average surgical duration for EMS was extended by 77.4 min. The rate of complications was comparable between the groups (EMS 14.3%, EIS 10.3%, p = 1.000). Conclusion: The findings indicate that while EMS requires a longer operation time because of decreased practicability in specific surgical steps, it provides comparable outcomes to EIS, underscoring the potential of endoscopic techniques to establish malleostapedotomy as a surgical option as it is with traditional incudostapedotomy. Level of Evidence: 4.

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The cause of sudden conductive loss in the absences of other vestibulo-audiologic abnormalities can be isolated to specific subsites of the ossicular chain using audiometric testing. In the absence of such abnormalities, a rare etiology may be the cause after an inciting trauma. Laryngoscope, 2024.

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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.

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BACKGROUND, AIMS: Stapes footplate thickness measurement using ultra-high-resolution CT has been described only in the lateral semicircular canal plane. The purpose of this study was to compare stapes footplate thickness between the lateral semicircular canal and stapes axial planes in patients with otosclerosis compared to controls. MATERIAL AND METHODS: We performed a retrospective single-center study of patients undergoing high-resolution temporal bone CT. Two radiologists measured stapes footplate thickness in both the lateral semicircular canal and stapes axial planes. RESULTS: Between February 2020 and October 2022, we collected 81 ears from 49 patients (75% of women; mean age 51.22 ± 16.6 years, 17 otosclerosis, and 64 controls). In the stapes axial plane, there was a significant anterior thickening in otosclerosis patients (Reader 1: 0.52 ± 0.12 [0.3-0.7] vs. 0.41 ± 0.08 [0.3-0.6], p = 0.001; Reader 2: 0.54 ± 0.06 [0.5-0.7] vs. 0.39 ± 0.08 [0.2-0.6], P < 0.001) compared to controls. These differences were not significant using the lateral semicircular canal plane. CONCLUSION: The stapes footplate was thickened at its AC in otosclerosis patients using only the stapes axial plane. SIGNIFICANCE: We propose to use the stapes axial plane instead of the lateral semicircular canal plane when analyzing the stapes.

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Introducción y objetivo: La otosclerosis es una causa de hipoacusia en jóvenes, con mayor frecuencia en mujeres. La cirugía del estribo es un procedimiento correctivo ampliamente aceptado, con el advenimiento de la tecnología y cambios en la técnica, surge la interrogante de si existen diferencias entre ellas. Objetivo: Evaluar si existen diferencias en la ganancia auditiva entre técnicas y abordajes de las cirugías del estribo en pacientes con otosclerosis Método: Se recabaron variables demográficas, clínicas y quirúrgicas. Se aplicó estadística descriptiva. Se empleó prueba U de Mann-Whitney para variables numéricas, así como Kruskal Wallis para comparación diferencias en tres o más grupos. Se consideró significativo un valor de p ≤ a 0.05. Resultados: Entre los años 2020 y 2023 se realizaron 55 cirugías de estribo por otosclerosis, de las cuales 20 se tuvieron que excluir. De 35 cirugías en 31 pacientes, la media de edad de 41.16 ± 8.64 años, 77.4% fueron mujeres, el 51.4 % fueron en el oído derecho; se presentaron comorbilidades en el 25.7%, las complicaciones 5 presentaron hipoacusia, el 88.6 % de los procedimientos se encontró un cierre satisfactorio de la brecha aérea y ósea. No se presentaron diferencia entre las técnicas de la cirugía de estribo y resultados audiológicos postquirúrgicos p=0.872, ni con el tipo de abordaje de visualización p=0.636. Discusión: Nuestros resultados son similares a lo que encontraron algunos autores, no obstante, aún sigue existiendo incertidumbre sobre la mejor técnica. Conclusiones: No se encontraron diferencias estadísticamente significativas en cuanto a la ganancia auditiva con el abordaje de visualización y el tipo de procedimiento en el estribo para la colocación de la prótesis. (AU)

Introduction and objective: Otosclerosis is a cause of hearing loss in young people, more frequently in women. Stapes surgery is a widely accepted corrective procedure, with the advent of technology and changes in technique, the question arises as to whether there are differences between them. Objective: To evaluate whether there are differences in hearing gain between techniques and approaches of stapes surgeries in patients with otosclerosis. Method: Demographic, clinical and surgical variables were collected. Descriptive statistics were applied. The Mann-Whitney U test was used for numerical variables, as well as the Kruskal Wallis test to compare differences in three or more groups. A p value ≤ 0.05 was considered significant. Results: Between 2020 and 2023, 55 stapes surgeries were performed for otosclerosis, of which 20 had to be excluded. Of 35 surgeries in 31 patients, mean age 41.16 ± 8.64 years, 77.4% were women, 51.4% were in the right ear; Comorbidities were present in 25.7%, 5 complications presented hearing loss, in 88.6% of the procedures a satisfactory closure of the air-bone gap was found. There was no difference between stapes surgery techniques and postsurgical audiological results p=0.872, nor with the type of visualization approach p=0.636. Discussion: Our results are similar to what some authors found, however, there is still uncertainty about the best technique. Conclusions: No statistically significant differences were found in terms of hearing gain with the visualization approach and the type of procedure in the stapes for placement of the prosthesis. (AU)

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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.

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One factor for the lacking integration of the middle ear stapes footplate prosthesis or the missing healing of stapes footplate fractures could be the known osteogenic inactivity. In contrast, it was recently demonstrated that titanium prostheses with an applied collagen matrix and immobilised growth factors stimulate osteoblastic activation and differentiation on the stapes footplate. Regarding those findings, the aim of this study was to evaluate the potential of bone regeneration including bone remodeling in the middle ear. Ten one-year-old female merino sheep underwent a middle ear surgery without implantation of middle ear prostheses or any other component for activating bone formation. Post-operatively, four fluorochromes (tetracycline, alizarin complexion, calcein green and xylenol orange) were administered by subcutaneous injection at different time points after surgery (1 day: tetracycline, 7 days: alizarin, 14 days: calcein, 28 days: xylenol). After 12 weeks, the temporal bones including the lateral skull base were extracted and histologically analyzed. Fluorescence microscopy analysis of the entire stapes with the oval niche, but in particular stapes footplate and the Crura stapedis revealed evidence of new bone formation. Calcein was detected in all and xylenol in 60% of the animals. In contrast, tetracycline and alizarin could only be verified in two animals. The authors were able to demonstrate the osseoregenerative potential of the middle ear, in particular of the stapes footplate, using fluorescence sequence labelling.

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To study the morphology and anthropometry of human ear ossicles from cadaveric temporal bone and to study the variations of the human ossicles from ossiculoplasty point of view. 38 sets of ear ossicles were collected, each containing malleus, incus and stapes, from temporal bone dissection done in Vasantrao Pawar medical college, Nashik. They were studied under microscope & anthropometrical, morphological evaluation done. Malleus showed variations in handle where 61% were straight and 39% curved. Weight of malleus ranged from 0.03-0.06 gm. The length ranged from 5.5 to 8.2 mm. Incus showed morphological variation in lenticular process which was present in 73% incii. Weight of incus ranged from 0.04 to 0.09 gm, average length of long process 3.5 mm, width of body 4 mm. In stapes variations was seen with head of stapes which was absent in 21% bones. With increasing awareness about postop hearing status, this study will add up in knowledge of morphological and anthropometric variations that exists in Indian population, help otologists to understand middle ear dynamics better which will improve results of ossiculoplasty.

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Objective:To compare the application of endoscope and microscope in all kinds of stapes surgeries. Methods:Fifty-nine stapes surgeries have been collected from April 2020 to May 2023 in Senior Department of Otolaryngology Head and Neck Surgery, Chinese PLA General Hospital, Chinese PLA Medical School. Hearing level, hospital stay post-operation, times of hospital visit post-operation, etc. have been compared between the endoscopic group and microscopic group. Patients who were failed to place the stapes prosthesis because of the poor exposure of the oval window have been analyzed. Results:Otosclerosis was the most common diagnosis in both groups. There was 1（1/23） middle ear malformation in the endoscopic group and 5（5/36） middle ear malformations in the microscopic group. There were 2 Van Der Hover syndromes and 4 Treacher Collins syndromes in the microscopic group. In the endoscopic group ABG of 10 ears（43.5%） ≤ 10 dB, and ABG of 21 ears（91.3%） ≤20 dB.In the microscopic group ABG of 13 ears（41.9%） ≤ 10 dB, and ABG of 28 ears（90.3%） ≤ 20 dB. There was no statistic difference between 2 groups. Times of hospital visit post-operation in the endoscopic group was less than in the microscopic group（P<0.01）. There was no facial palsy, tympanic perforation or profound sensorineural hearing loss in both groups. Conclusion:Endoscope is more suitable for patients who are evaluated with no severe stapes malformation, or less manipulation of drilling the bone. It could also reduce the hospital visit post-operation. Patients with narrow ear canal or severe middle ear malformation are recommended to perform the surgery with microscope, because it provides the chance of manipulation with 2-hands of surgeons.

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Objective: The involvement of the inner ear in otosclerosis may lead to the development of cochlear otosclerosis. The aim of this study was to analyse changes in the chemical composition and microstructure of the stapes in the course of otosclerosis compared to healthy stapes. Materials and methods: This analysis included 31 patients with otosclerosis and 9 patients without otosclerosis. Microanalytical and diffraction techniques were used to assess the elemental distribution and orientation topography of the stapes. Results: The concentration of Ca2+ in the study group was significantly lower in the area of the anterior crus of the stapes than in the posterior crus. A reduction in the Ca2+/P3+ ratio in the anterior crus was associated with deteriorated bone conduction and tinnitus. Degradation of the stapes microstructure in the area of otosclerotic lesions was observed with scanning electron microscopy. Conclusions: Bone remodelling is most significant at the closest location to typical otosclerotic lesions with hydroxyapatite porosity and scale-like bone formation according to scanning electron microscopy. There is a relationship between the disturbance of calcium metabolism and the development of clinical symptoms of cochlear otosclerosis.

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OBJECTIVES: To compare the hearing outcomes of ossicular chain reconstruction using bone cement versus other materials such as prostheses and autografts. METHODS: This study included articles that compared hearing outcomes in patients with conductive hearing loss who underwent stapes revision surgery or chronic otitis media surgery. A systematic search for articles from January 2000 to February 2022 was conducted in Medline, Embase, and Cochrane Library databases. Only articles in English were included. An effective postoperative air-bone gap (ABG) was defined as ≤20 dB. A bias assessment tool was developed according to Cochrane guidelines, and the chi-square test was used to evaluate the mean age of the samples. RESULTS: Of the 418 studies that met the selection criteria, only seven were eligible for this study, consisting of 187 patients in the bone cement group and 173 in the non-bone cement group. Ossiculoplasty using bone cement yielded significantly better results, with a combined odds ratio (OR) of 2.03 (95% CI: 1.16-3.55, p = 0.01). CONCLUSIONS: The results of this study suggest that the effectiveness of bone cement in ossiculoplasty was greater than that of other materials in chronic otitis media surgery or stapes revision surgery, with a higher number of patients achieving ABG ≤20 dB.

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OBJECTIVE(S): Recently directed methods of inner ear drug delivery underscore the necessity for understanding critical anatomical dimensions. This study examines anatomical measurements of the human middle and inner ear relevant for inner ear drug delivery studied with three different imaging modalities. METHODS: Post-mortem human temporal bones were analyzed using human temporal bone histopathology (N = 24), micro computerized tomography (µCT; N = 4), and synchrotron radiation phase-contrast imaging (SR-PCI; N = 7). Nine measurements involving the oval and round windows were performed when relevant anatomical structures were visualized for subsequent age-controlled analysis, and comparisons were made between imaging methods. RESULTS: Combined human temporal bone histopathology showed the mean distance to the saccule from the center of the stapes footplate (FP) was 2.07 ± 0.357 mm and the minimum distance was 1.23 mm. The mean distance from the round window membrane (RWM) to the osseous spiral lamina (OSL) was 1.75 ± 0.199 mm and the minimum distance was 1.43 mm. Instruments inserted up to 1 mm past the center of the FP are unlikely to cause saccular damage, provided there are no endolymphatic hydrops. Similarly, instruments inserted up to 1 mm through the RWM in the trajectory toward the OSL are unlikely to cause OSL damage. CONCLUSION: The combined analyses of inner-ear dimensions of age-controlled groups and imaging modalities demonstrate critical dimensions of importance to consider when inserting delivery vehicles into the human cochlea. LEVEL OF EVIDENCE: N/A Laryngoscope, 134:2879-2888, 2024.

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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.

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