Partial Ossicular Reconstruction With a Novel Ball Joint Prosthesis: The mCLIP ARC Partial Prosthesis.

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.

Long-Term Stability and Safety of the Soundbridge Coupled to the Round Window.

OBJECTIVE: The objective of the study was to demonstrate the long-term outcomes of patients implanted with the active middle ear implant (AMEI) Vibrant Soundbridge (VSB) through coupling the floating mass transducer (FMT) to the round window (RW). METHODS: This retrospective study evaluated the short- and long-term clinical performance (audiological outcomes) and safety (revisions/explantations) of the VSB coupled to the RW between 2013 and 2019 at the St. Pölten University Hospital, Austria. For the outcome analysis, the sample was divided into a short-term examination group followed up for less than 12 months (<12 months) and a long-term examination group followed up for more than 12 months (>12 months). Cumulative survival outcomes were separately analyzed for subjects with and without cholesteatoma. RESULTS: 46 patients with an average long-term follow-up period of 31.43 months (13-75 months) were investigated. Complications requiring revision surgery were reported in total in seven patients with cholesteatoma (15.2%) and none in subjects without cholesteatoma (0%). Residual hearing was not affected by VSB surgery. Word understanding on the Freiburger monosyllabic speech test improved significantly at 65 dB (P < .0001) and 80 dB (P < .0001), and these outcomes were stable for long-term follow up. CONCLUSION: The VSB coupled to the RW is a safe implantation method for patients with conductive or mixed hearing loss. Hearing improvement was stable for the long-term follow-up up to 74 months. The revision rates are directly related to the underlying pathology of cholesteatoma (with radical cavity); thus, this special cohort requires additional counseling on potential complications. LEVEL OF EVIDENCE: 4 (Case-series) Laryngoscope, 131:E1434-E1442, 2021.

Displacement of a Total Ossicular Replacement Prosthesis Following Ossicular Chain Reconstruction.

OBJECTIVE: Herein we describe the diagnosis and management of total ossicular replacement prosthesis (TORP) displacement following tympanoplasty with ossicular chain reconstruction (OCR). METHODS: Case report with literature review. RESULTS/CASE: A 40-year-old male with otorrhea and tympanic membrane perforation underwent a right revision tympanoplasty with OCR using a TORP with a tragal chondroperichondrial graft. On postoperative day (POD) 4, he developed vertigo and profound right-sided hearing loss. Temporal bone computed tomography showed the prosthesis in the vestibule. After a steroid taper with mild improvement in symptoms, the TORP was removed two weeks later and the patient continued to improve. CONCLUSION: TORP displacement into the vestibule is a very rare complication following OCR. Conservative management with high dose steroids may improve symptoms, however further middle ear exploration and surgical management may be warranted depending on the depth of displacement into the inner ear as well as symptom severity.

Long-term outcomes of ossiculoplasty using bone cement.

OBJECTIVE: This study aimed to evaluate the long-term results of ossiculoplasty using bone cement. METHOD: Forty patients (24 females and 16 males; mean age: 34.1 ± 11.8 years; range, 9-54 years) with chronic otitis media with perforation but without cholesteatoma who had undergone incudostapedial rebridging ossiculoplasty using bone cement were evaluated retrospectively. Pre-operative and post-operative audiograms were evaluated. Bone conduction, air conduction and air-bone gaps were calculated according to international guidelines. RESULTS: There was a mean reduction in pre-operative and post-operative air conduction (12.30 ± 11.98 dB), and this result was significant (p = 0.0001). There was a mean reduction in pre-operative and post-operative bone conduction (4.30 ± 6.69 dB), and this result was significant (p < 0.0001). The pre-operative air-bone gap was 27.65 dB and decreased to 19.65 dB during follow-up (p = 0.0001). No adverse reactions or complications were observed. CONCLUSION: Bone cement is reliable for the repair of incudostapedial-joint defects.

Vibroplasty combined with tympanic membrane reconstruction in middle ear ventilation disorders.

Although the Vibrant Soundbridge is one of the most frequently used active middle ear implants, data regarding how middle ear ventilation disorders may affect the transmission behavior of its floating mass transducer are still insufficient. Studies involving coupling the floating mass transducer to the stapes head are particularly lacking. This temporal bone study evaluated the influence of simulated middle ear ventilation disorders on the middle ear transfer function in the reconstructed middle ear. The middle ear transfer function was measured using Laser Doppler Vibrometry after vibroplasty onto the stapes head, with or without tympanic membrane reconstruction. Middle ear ventilation disorders were simulated through changes in static pressure via the external ear channel with a maximum pressure of +3 kPa. Slice thickness of tympanic membrane reconstruction material was measured using micro-CT. When the reconstructed ossicular chain and the reconstructed tympanic membrane were mechanically excited by the floating mass transducer under conditions of ambient static pressure, the transmission behavior was found to be independent of the type of tissue used. Increase in static pressure up to +3 kPa caused maximum low frequency transmission loss of 15 dB when elastic grafts were used and 5 dB when stiff tissue was inserted. At high frequencies, measured loss of up to 5 dB was relatively independent of the tissue stiffness. Increase in static pressure led to displacement of the tissues towards the vestibulum and caused stiffening, especially of the annular ligament. Stiffening-induced transmission losses were mainly found at low frequencies and could not be compensated by the floating mass transducer in this range. Above 1300 Hz, the continuous force spectrum of the actuator sufficiently protected against loss of amplitude. To minimize postoperative transmission loss due to persisting ventilation disorders, choosing a very stiff tympanic membrane reconstruction material seems to be appropriate.

Improved directional hearing of children with congenital unilateral conductive hearing loss implanted with an active bone-conduction implant or an active middle ear implant.

Different amplification options are available for listeners with congenital unilateral conductive hearing loss (UCHL). For example, bone-conduction devices (BCDs) and middle ear implants. The present study investigated whether intervention with an active BCD, the Bonebridge, or a middle ear implant, the Vibrant Soundbridge (VSB), affected sound-localization performance of listeners with congenital UCHL. Listening with a Bonebridge or VSB might provide access to binaural cues. However, when fitted with the Bonebridge, but not with a VSB, binaural processing might be affected through cross stimulation of the contralateral normal hearing ear, and could interfere with processing of binaural cues. In the present study twenty-three listeners with congenital UCHL were included. To assess processing of binaural cues, we investigated localization abilities of broadband (BB, 0.5-20 kHz) filtered noise presented at varying sound levels. Sound localization abilities were analyzed separately for stimuli presented at the side of the normal-hearing ear, and for stimuli presented at the side of the hearing-impaired ear. Twenty-six normal hearing children and young adults were tested as control listeners. Sound localization abilities were measured under open-loop conditions by recording head-movement responses. We demonstrate improved sound localization abilities of children with congenital UCHL, when listening with a Bonebridge or VSB, predominantly for stimuli presented at the impaired (aided) side. Our results suggest that the improvement is not related to accurate processing of binaural cues. When listening with the Bonebridge, despite cross stimulation of the contralateral cochlea, localization performance was not deteriorated compared to listening with a VSB.

Function, Applicability, and Properties of a Novel Flexible Total Ossicular Replacement Prosthesis With a Silicone Coated Ball and Socket Joint.

HYPOTHESIS: A total ossicular replacement prosthesis (TORP) with a silicone coated ball and socket joint (BSJ) is able to compensate pressure changes and therefore provide better sound transmission compared with rigid prostheses. BACKGROUND: Dislocation and extrusion are known complications after TORP reconstruction, leading to revisions and recurrent hearing loss. Poor aeration of the middle ear, scar tension, and static pressure variations in conjunction with rigid prosthesis design causes high tension at the implant coupling points. METHODS: A novel TORP prototype with a silicone coated BSJ has been developed. Experimental measurements were performed on nine fresh cadaveric human temporal bones of which five were used for a comparison between rigid TORP and flexible TORP tympanoplasty. The middle ear transfer function was measured at ambient pressure and at 2.5 kPa, both positive and negative pressure, applied in the ear canal. RESULTS: The flexible TORP design yields a better transmission of sound after implantation and at negative pressure inside the tympanic cavity, compared with rigid TORP. In average, it provides an equivalent sound transfer like the intact middle ear. At positive pressure, the flexible TORP performs slightly worse. Both performed worse than the intact middle ear, which is related to an uplifting of the prostheses. CONCLUSION: The findings may be considered preliminary as this experimental study was limited to just one of the many different possible situations of tympanoplasty and it involved a small sample size. Nevertheless, the results with the flexible TORP were promising and could encourage further investigations on such prostheses.

Long-term Hearing Outcome of Canaloplasty With Partial Ossicular Replacement in Congenital Aural Atresia.

OBJECTIVE: The aim of this study was to correlate the postoperative hearing outcomes with regard to the length of prosthesis of the partial ossicular replacement prosthesis (PORP) in patients with congenital aural atresia. STUDY DESIGN: Retrospective review of medical records. SETTING, PATIENTS, INTERVENTION, MAIN OUTCOME MEASURE: The medical records of 131 patients (132 ears) who underwent canaloplasty with PORP by a single surgeon from 2011 to 2016 were reviewed for demographic data, Jahrsdoerfer score, grade of microtia, length of prosthesis, and audiometric outcomes. Air conduction, bone conduction threshold, and air-bone gap were measured preoperatively and at 3-, 6-, 12-, and 24-months of follow-up. Patients were divided into two groups according to the postoperative hearing outcomes, and the length of PORP was compared between the two groups. Univariable and multivariable generalized estimating equations were used to investigate other favorable prognostic factors for long-term postoperative hearing results. RESULTS: When the improvement of the air-bone gap within 30 dB was defined as successful hearing outcome, no significant differences were observed for prosthesis length between two groups at 3, 6, and 12 months postoperatively. However, at 2-year follow-up, mean length of prosthesis was significantly shorter (p = 0.006) for the success group (2.30 ± 0.53 mm) than for the nonsuccess group (2.77 ± 0.73 mm). Generalized estimating equations revealed PORP length as the only factor significantly associated with favorable long-term hearing results. CONCLUSION: Long-term hearing outcome of canaloplasty with PORP is likely to be affected by prosthesis length. For that reason, making the neo-annulus as medial as possible to shorten the length of the appropriate prosthesis is important for successful long-term hearing outcomes.

Short and Long-Term Outcomes of Titanium Clip Ossiculoplasty.

OBJECTIVE: To report short (∼4 mo) and long-term (>12 mo) audiometric outcomes following ossiculoplasty using a titanium clip partial ossicular reconstruction prosthesis. METHODS: Case series at a single tertiary referral center reviewing 130 pediatric and adult patients with conductive hearing loss (CHL) secondary to chronic otitis media (n = 121, 93%) or traumatic ossicular disruption (n = 9, 7%) who underwent partial ossiculoplasty from January 2005 to December 2015 with the CliP prosthesis. RESULTS: At both short and long-term follow-up, postoperative air-bone gap (ABG) was significantly improved (18 dB HL, IQ range 13-26, p < 0.0001 and 18 dB HL, IQ range 13-29, p = 0.0002, respectively) when compared with preoperative values (29 dB HL, IQ range 19-37). No significant change in ABG was noted when comparing short and long-term intervals (18 versus 18 dB HL, p = 0.44). Fifty seven percent of cases (51/89) achieved a long-term ABG less than or equal to 20 dB at the time of their last follow-up. The extrusion and displacement rates were 1.5% (2/130), and 0.8% (1/130), respectively. There were no cases of iatrogenic sensorineural hearing loss. CONCLUSIONS: Partial ossiculoplasty with the titanium CliP produces good hearing outcomes with a favorable safety profile. At long-term follow-up (minimum of 12 mo), median ABG was 18 dB and remained stable when compared with short-term follow-up. The majority of patients had successful long-term results, with 57% of patients achieving an ABG is less than or equal to 20 dB. Low rates of extrusion (1.5%) and prosthesis displacement off the stapes (0.8%) support the long-term stability of the CliP prosthesis in the middle ear.

Comparative study of new autologous material, bone-cartilage composite graft, for ossiculoplasty with Polycel® and Titanium.

OBJECTIVE: Ossiculoplasty is a surgical procedure that recreates sound transmission of the middle ear in conductive hearing loss. Various materials have been used for ossicular reconstruction, but the most ideal material for ossiculoplasty remains controversial. The purpose of this study was to introduce a novel method of autologous ossiculoplasty, bone-cartilage composite graft (BCCG) and to compare its surgical results with different types of ossiculoplastic prostheses. STUDY DESIGN: A retrospective study was performed in a tertiary referral centre. METHODS: Data of 275 patients who received ossiculoplasty using the three different materials of BCCG, Polycel® and titanium were analysed according to type of ossiculoplasty: partial or total ossicular replacement prosthesis (PORP or TORP). Hearing results, complication rates and clinical parameters including age, sex, past history, preoperative diagnosis and surgery type were compared among different groups. RESULTS: Ossiculoplasty with BCCG showed satisfactory hearing outcomes and the lowest complication rate among the three different materials. In particular, its extrusion rate was 0%. CONCLUSION: We propose that the BCCG technique is a useful alternative method for ossiculoplasty, with proper patient selection.

Active transcutaneous bone conduction implant: audiological results in paediatric patients with bilateral microtia associated with external auditory canal atresia.

OBJECTIVE: To describe, in terms of functional gain and word recognition, the audiological results of patients under 18 years of age implanted with the active bone conduction implant, Bonebridge™. DESIGN: Retrospective case studies conducted by reviewing the medical records of patients receiving implants between 2014 and 2016 in the public health sector in Chile. STUDY SAMPLE: All patients implanted with the Bonebridge were included (N = 15). Individuals who had bilateral conductive hearing loss, secondary to external ear malformations, were considered as candidates. RESULTS: The average hearing threshold one month after switch on was 25.2 dB (95%CI 23.5-26.9). Hearing thresholds between 0.5 and 4 kHz were better when compared with bone conduction hearing aids. Best performance was observed at 4 kHz, where improvements to hearing were observed throughout the adaptation process. There was evidence of a significant increase in the recognition of monosyllables. CONCLUSIONS: The Bonebridge implant showed improvements to hearing thresholds and word recognition in paediatric patients with congenital conductive hearing loss.

Clinical predictors for satisfaction with incus vibroplasty: a preliminary study.

OBJECTIVE: We aimed to evaluate the subjective satisfaction after incus vibroplasty and to determine predictive factors affecting patient satisfaction in sensorineural hearing loss. DESIGN: A retrospective review of audiological data and an additional survey about subjective satisfaction after surgery were performed in 14 patients who underwent incus vibroplasty surgery. A numeric rating scale reflecting the degree of satisfaction after incus vibroplasty, compared with experiences using a conventional hearing aid, was used. Patients who showed median or better satisfaction were deemed the highly satisfied (HS) group, and the others were deemed the less satisfied (LS) group. To find the predictive factors correlated with satisfaction for incus vibroplasty, comparative analysis between two groups was performed. RESULTS: We found that the numeric rating scale for satisfaction was variable, ranged from 0 to 10, and was negatively correlated with age at operation (p < 0.01). The HS group had a younger age (27.6 ± 22.2 years) and better preoperative air conduction threshold at 250 Hz (20.7 ± 7.9 dB) than the LS group (68.0 ± 9.7 years, 32.1 ± 10.7 dB). The LS group (13.6 ± 9.9 dB) showed a larger change of air-bone gap after surgery than the HS group (5.7 ± 6.7 dB) at 250 Hz (p = 0.12). CONCLUSIONS: Age at operation and the preoperative air conduction threshold level at 250 Hz appear to be potential predictive factors for subjective satisfaction with incus vibroplasty. Furthermore, more conservative selection of candidates and caution during surgery, considering inevitable air-bone gap development postoperatively, may be necessary to achieve higher satisfaction for incus vibroplasty.

[The application of stapedoplasty for the treatment of hearing loss in the patients suffering from obliterative otosclerosis]. / Stapedoplastika v lechenii tugoukhosti u bol'nykh obliteriruiushchim otosklerozom.

This article presents the results of analysis of the data obtained during the examination and the surgical treatment of the patients presenting with the obliterative form of otosclerosis and suffering from hearing impairment with special reference to the intraoperative findings, technical aspects of stapedoplasty, and its effectiveness. A total of 14 patients (17 ears) were recruited for the participation in the present study including 10 women at the mean age of 38.8±6.2 years and 4 men (mean age 44.8±3.9 years). The duration of the hearing loss in the period preceding the surgical treatment in 7 (50%) patients was more than 8 years. According to the results of tonal threshold audiometry (TTA), the mean bone conduction (BC) threshold for conductive hearing loss in the frequency range from 0.5 to 4.0 kHz was 24.9±8.1 dB with the mean bone air gap (BAG) equaling 38±5.1 dB. Computed tomography (CT) of the temporal bones revealed grade 1 obliterative otosclerosis in 4 patients, grade II of the same condition in 6 patients, and grade III in 7 ones. These findings were confirmed intraoperatively. In 15 cases, stapedostomy was carried out with the use of the non-contact CO2 laser-based system, in the remaining cases a microdrill was employed. Five patients underwent laser-assisted piston stapedoplasty while in 11 others the stapes prosthesis was placed on the autovein. One patient was treated by the same method with the use of the autocartilaginous prosthesis. The functionally acceptable results within 1 year after the surgical intervention were obtained in all the treated patients with the mean bone air gap equaling 13.2±3.4 dB. The best outcome (the reduction of the BC threshold and BAG by 7 dB and 25.9 db on the average respectively within 1 year after surgery was achieved in the patients with grade III obliterative otosclerosis.

Titanium incus interposition ossiculoplasty: audiological outcomes and extrusion rates.

This study aimed to evaluate the benefit but also the extrusions, dislocations, and failures of a titanium incus prosthesis along with the long-term audiological outcomes. We prospectively collected data from 139 patients undergoing ossiculoplasty using the Fisch titanium incus prosthesis between 2001 and 2016. Overall, 126 patients with at least 6 months of follow-up (mean 4.5 years, range 6-155 months) were analyzed. Patients were grouped as "extrusion" (n = 9, 7%) if the prosthesis extruded, "failure" (n = 22, 18%) if a reoperation was needed concerning the prosthesis, and "stable" (n = 95, 75%) if the prosthesis remained functional in the middle ear. Mean postoperative air bone gaps (ABG) for 0.5-3 kHz for the overall group and the stable group were 19.8 (±11.9) and 15.3 (±7.5), respectively. Long-term results of stable group revealed an ABG (0.5-3 kHz) below 10 dB in 25% and below 20 dB in 81% of the patients. Atelectasis was the most frequent cause of extrusion, which occurred after a mean time of 28.7 months (range 15-48 months). Mean timing for reoperation was 30.7 months (range 5-131 months) in the failure group. There was no significant difference in mean postoperative ABG among patients with or without cholesteatoma, primary or staged ossiculoplasty in cholesteatoma, presence or absence of malleus head at the time of ossiculoplasty, open or closed cavity surgeries, or the degree of pneumatization of the temporal bone. The Fisch titanium incus prosthesis is a reliable alternative to using autologous incus for interposition ossiculoplasty, with similar hearing outcomes. Using this prosthesis, a 15 dB ABG should be expected.

Results of VSB implantation at the short process of the incus in children with ear atresia.

OBJECTIVE(S): To describe a new and more simple surgical procedure for implanting the Vibrant Soundbridge (VSB) on the short process of the incus in children with ear atresia and atretic plate and present the audiometric results. METHODS: Since 2014, pre- and post-operative audiometric tests with tonal and vocal audiometryat the maximal follow up, respectively 33, 22 and 12 months were performed after VSB implantation at the ENT department, Necker Enfants Malades Hospital, Paris, France. 3 children aged 11, 9 and 15 years with conductive hearing loss due to high grade ear atresia and absent ear canal were implanted. The malformed and fused malleus-incus complex was found to be immobile in two of the subjects, who then underwent a superior tympanotomy to carefully remobilize the malleus. Stapes were mobile in all cases. The FMT clip was customized and crimped on the short process, stabilized by the metallic wire. RESULTS: At the maximum follow-up time, the bone conduction was unchanged, and the mean aided ACPTA was 21 dB, 29 dB and 30 dB, compared to 66 dB, 63 dB and 68 dB unaided, respectively. The word recognition score (WRS) at 65 dB SPL increased from 10%, 10% and 70% (unaided) respectively to 100% (aided). CONCLUSIONS: The long process of the incus is usually very hypoplastic in patients with ear atresia with a fused malleus-incus complex lateral to the stapes. VSB coupling to the long process of the incus or the stapes may be challenging in small mastoids. Coupling to the short process of the incus is comparatively a simple procedure, since there is no need for posterior tympanotomy and has no proximity to the facial nerve. The results of this study are similar to other ear atresia cases in the literature with classic FMT placement on the stapes or long process of the incus. Outcomes should be confirmed in a larger number of patients.

A new malleostapedotomy prosthesis. Experimental analysis by laser doppler vibrometer in fresh cadaver temporal bones. / Análisis experimental mediante vibrometría láser doppler en huesos temporales de cadáver fresco de una nueva prótesis de maleovestibulopexia.

INTRODUCTION AND OBJECTIVES: One of the problems with total ossicular replacement prostheses is their stability. Prosthesis dislocations and extrusions are common in middle ear surgery. This is due to variations in endo-tympanic pressure as well as design defects. The design of this new prosthesis reduces this problem by being joined directly to the malleus handle. The aim of this study is to confirm adequate acoustic-mechanical behaviour in fresh cadaver middle ear of a new total ossicular replacement prosthesis, designed using the finite elements method. METHODS: Using the doppler vibrometer laser, we analysed the acoustic-mechanical behaviour of a new total ossicular replacement prosthesis in the human middle ear using 10 temporal bones from fresh cadavers. RESULTS: The transfer function of the ears in which we implanted the new prosthesis was superimposed over the non-manipulated ear. This suggests optimum acoustic-mechanical behaviour. CONCLUSIONS: The titanium prosthesis analysed in this study demonstrated optimum acoustic-mechanical behaviour. Together with its ease of implantation and post-surgical stability, these factors make it a prosthesis to be kept in mind in ossicular reconstruction.

Performance of the round window soft coupler for the backward stimulation of the cochlea in a temporal bone model.

The round window vibroplasty is a feasible option for the treatment of conductive, sensorineural and mixed hearing loss. Although clinical data suggest a satisfying clinical outcome with various coupling methods, the most efficient coupling technique of the floating mass transducer to the round window is still a matter of debate. For this, a soft silicone-made coupler has been developed recently that aims to ease and optimize the stimulation of the round window membrane of this middle ear implant. We performed a temporal bone study evaluating the performance of the soft coupler compared to the coupling with individually shaped cartilage, perichondrium and the titanium round window coupler with loads up to 20 mN at the unaltered and fully exposed round window niche. The stimulation of the cochlea was measured by the volume velocities of the stapes footplate detected by a laser Doppler vibrometer. The coupling method was computed as significant factor with cartilage and perichondrium allowing for the highest volume velocities followed by the soft and titanium coupler. Exposure of the round window niche allowed for higher volume velocities while the applied load did not significantly affect the results. The soft coupler allows for a good contact to the round window membrane and an effective backward stimulation of the cochlea. Clinical data are mandatory to evaluate performance of this novel coupling method in vivo.

Hearing outcome after sequential cholesteatoma surgery.

The objective of this study was to assess hearing outcome after sequential cholesteatoma surgery stratified for exclusively transcanal technique (ETC), combined transcanal and transmastoidal technique (TCM) and canal wall down surgery (CWD) and to analyze the impact of ossicular reconstruction technique (partial ossicular replacement prostheses/PORP and total ossicular replacement prostheses/TORP) on hearing outcome. This study is a retrospective case review and clinical case study conducted in a tertiary referral center. Patients who underwent 376 cholesteatoma surgeries (2007-2009) and 92 ears in clinical re-examination at least 12 months postoperatively were included. Sequential cholesteatoma surgery with ETC, TCM, or CWD; ossiculoplasty with PORP or TORP were the interventions administered. Pre- and postoperative air-bone gap (ABG) and air conduction threshold (AC) for 0.5-3 kHz were the main outcome measures. Overall, the mean preoperative ABG decreased from 25.3 ± 1.3 to 19.8 ± 0.9 dB with a mean ABG closure of 5.4 ± 1.3 dB (p ≤ 0.001). According to surgical technique, the postoperative ABG after CWD 23.5 ± 2.1 was significantly worse compared to ETC (17.3 ± 1.0 dB, p < 0.05) and TCM (19.4 ± 1.3 dB). A significant ABG closure was observed after ETC (6.8 ± 2.0 dB, p < 0.01) and TCM (6.5 ± 2.0 dB, p < 0.01) contrary to CWD (2.1 ± 2.9 dB, p > 0.05). Patients receiving PORP showed a significantly less ABG postoperatively (19.0 ± 0.9 dB, p ≤ 0.05) compared to the TORP group (24.1 ± 2.5 dB). However, a significant hearing gain was assessed after PORP- (4.7 ± 1.6 dB, p ≤ 0.01) and TORP- implantation (10.4 ± 3.7 dB, p ≤ 0.01). Sequential cholesteatoma surgery allowed for an excellent hearing outcome postoperatively. An intact posterior canal wall and a present stapes suprastructure were identified to predict a significantly superior hearing result. In addition to the technical and prosthetic considerations, the audiological outcome was confounded by the attending middle ear pathology.

[Stapes surgery for otosclerosis using a new titanium prosthesis with a superelastic nitinol clip: First experiences]. / Stapeschirurgie bei Otosklerose mit einer neuen Titanprothese mit superelastischem Nitinol-Clip: Erste Erfahrungen.

BACKGROUND: Coupling of the prosthesis to the long process of the incus is a critical step in stapes surgery. We report first experiences with the NiTiFLEX® stapes prosthesis, a further development of the Soft CliP® stapes prosthesis (Kurz, Dusslingen, Germany). Instead of pure titanium, the CliP® now consists of nitinol, a superelastic nickel-titanium alloy. This further reduces the pressure exerted on the long process of the incus, aiming to improve coupling and minimize the risk of incus luxation. METHODS: In a monocentric, retrospective cohort study, we evaluated air-bone gap reduction (4PTA0.5-4 kHz), understanding of monosyllables at 65 and 80 dB SPL stimulation levels, and adverse effects, such as changes in bone conduction (4PTA0.5-4 kHz). During a 12-month period (May 2014 to April 2015), stapes surgery was performed in 21 otosclerosis patients using the NiTiFLEX® prosthesis. The footplate was perforated using a CO2 laser (scanning mode; 0.7 mm; 20-21 W) in almost all cases. The diameter of the titan piston was 0.4 mm. Immersion at an angle of almost 90° thus results in a gap between the footplate perforation and the piston of 0.15 mm. Positioning onto the long incus process was performed with a 90°microhook (0.6 mm). RESULTS: In all cases the NiTiFLEX® stapes prosthesis was inserted without complications. The mean bone conduction threshold did not change significantly postoperatively and the mean air-bone gap (4PTA0.5-4 kHz) improved on average from 29.0 to 9.5 dB HL. Handling of the prosthesis was rated as very good. CONCLUSION: The limited experience of this study suggests that the NiTiFLEX® stapes prosthesis is a successful further development of the Soft CliP® technique with very good intraoperative handling qualities. While long-term results from larger studies are needed, this case series demonstrates that the hearing outcome is comparable to other prostheses.

Parameters for novel incus replacement prostheses.

Prostheses replacing the incus in its normal position and equipped with two joints might transfer sound as effectively as the intact ossicular chain and allow adjustment to quasi-static pressure changes. A prerequisite for prostheses development is the access to dimensions and distances of the ossicular chain which are necessary to conceptualize shape and size. Fifteen cadaveric human temporal bone specimens were investigated by means of micro-CT followed by 3D analysis. Each specimen was scanned three times: after removal of incus, after additional removal of the malleus head, and after approaching the umbo to the promontory. Artificial umbo medialization as a surrogate for quasi-static pressure changes leads to relevant variations in the distance between the upper part of the malleus and the stapes. Prostheses replacing the incus in its normal position should be equipped with a sliding ball joint or similar construction to allow adjustment to quasi-static pressure changes.