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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. [ABSTRACT FROM AUTHOR]

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

Objective: To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant.Methods: This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects.Results: Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively.Conclusion: A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery. [ABSTRACT FROM AUTHOR]

Objective: To evaluate possible increases in bone conduction (BC) hearing thresholds in patients undergoing subtotal petrosectomy (SP) with fat obliteration and blind sac closure of the outer ear canal and subsequent round window vibroplasty.Patients and Interventions: Between 1997 and 2013, 43 patients (45 ears) with combined hearing loss and recurrent chronic otitis or status post formation of a radical cavity underwent SP around 6 months prior to implantation of a Vibrant SoundbridgeTM. Pure tone audiograms (0.5, 1, 1.5, 2, 3, 4, and 6 kHz) prior to SP, after SP, prior to implantation, after implantation, and at first fitting around 5 weeks after implantation were collected and statistically analyzed.Results: The comparison between BC thresholds before SP and at first fitting showed an overall decline during the two-step procedure between 2.8 and 6 dB that was significant (p < 0.05, Student t test) at 2, 3, 4, and 6 kHz.Conclusion: In some cases, SP is the only way to eradicate chronic otitis and to achieve a suitable environment for the implantation of active middle ear implants. The present data demonstrate a relatively small but significant decline in BC thresholds throughout the whole procedure. Knowledge of its extent is mandatory for a correct indication for later implantation of a Vibrant SoundbridgeTM. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study is to retrospectively analyze the imaging characteristics of patients with congenital aural atresia who underwent Vibrant Soundbridge implantation, and to investigate the importance of preoperative evaluation of vibroplasty. Materials and methods: The study included 16 patients with bilateral congenital aural atresia aged 6-25 years (mean age, 14.7 years). All patients underwent Vibrant Soundbridge implantations. Results: Among the 16 patients, 15 successfully underwent stapes implantation. The average height of the stapes of these 15 patients was 2.93 mm, which was significantly different from that of the control group with normal hearing (p≤.001). The average distance between the tympanic segment of the facial nerve and the stapes was 1.41mm in patients in whom the oval window was occluded by the displaced facial nerve. In the non-occluded group, the average distance was 2.00 mm. No significant difference was observed between the two groups (p=.08). Conclusion: The distance between the facial nerve and stapes, as well as the height of the stapes, could be important predictors of successful stapes implantation of Vibrant Soundbridge. [ABSTRACT FROM AUTHOR]

The active middle ear implant Vibrant Soundbridge© provides a variety of coupling modalities of the floating mass transducer (FMT) to various structures of the ossicular chain and the round window. A retrospective analysis was performed on 125 subjects (n = 137 ears) (1) to compare the efficacy of the different FMT coupling modalities with increasing degree of hearing loss, (2) to compare the performance in speech outcome and the effective gain between the coupling types, and (3) to evaluate the risk of additional hearing loss of each coupling procedure. The patients were grouped according to their type of FMT coupling into incus vibroplasty (incus group, n = 59), round window vibroplasty with coupler (RWC group, n = 23), round window vibroplasty without coupler (RW group, n = 22), and oval window vibroplasty with coupler (OWC group, n = 33). For each coupling group, pre- and postoperative thresholds, the results of the Freiburg monosyllable test at 65 dB SPL, and the effective gain across frequencies (0.5-6 kHz) were evaluated. A logistic regression function was used to describe the relationship between word recognition scores (WRS, in % correct) and the mean bone conduction (BC) hearing loss. The surgical procedure had no clinically relevant effect on BC thresholds of patients in each coupling group. The BC pure tone average (PTA4) for 50% WRS predicted by the model function was similar for the incus (48.2 dB nHL), RW (47.8 dB nHL), and OWC (49.0 dB nHL) groups, but higher for the RWC group (67.9 dB nHL). However, the median WRS was 80% or better with no significant differences in speech perception between coupling types (Kruskal-Wallis test, p = 0.229). The effective gain shows an advantage for the incus coupling between 0.5 and 2 kHz over the other coupling types. The performance of the FMT coupling modalities is equally good for patients with a mild-to-moderate hearing loss, but the efficacy of coupling types differs for patients with greater hearing loss (>48 dB BC HL). [ABSTRACT FROM AUTHOR]

Objective: To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant.Methods: This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction.Results: Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients.Conclusion: A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery. [ABSTRACT FROM AUTHOR]

Objectives To report an integrating surgical method of Vibrant SoundBridge (VSB) implant and auricle reconstruction. Methods 4 cases of congenital bilateral external/middle ear malformation were enrolled. All of them were diagnosed as bilateral bony atresia and grade III microtia. Stapes vibroplasty was performed for all subjects in one operation with auricle reconstruction stage 3. The clinical information and hearing outcomes were analyzed. Results Satisfied aesthetic outcomes were confirmed by sculptured outline and symmetric shape on both sides. Mean improvement in hearing threshold with VSB activation was 25.9 dB HL, while mean scores of speech recognition test were 21.8–46.3%. Conclusion Combined surgical method of VSB implant and aesthetic reconstruction is safe and efficient for congenital external/middle ear malformation case. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to review current knowledge regarding implantation of the Vibrant Soundbridge floating mass transducer (FMT) at the round window (round window vibroplasty) as well as to form a consensus on steps for a reliable, stable surgical procedure. Data Sources: Review of the literature and experimental observations by the authors. Conclusion: Round window (RW) vibroplasty has been established as a reliable procedure that produces good and stable results for patients with conductive or mixed hearing loss. The experience gained over the past few years of the authors’ more than 200 implantations has led to consensus on several key points: (1) a wide and bloodless access to the middle ear with facial nerve monitoring, (2) the careful and correct identification and exposure of the round window membrane, (3) a good setup for efficient energy transition of the FMT, namely, perpendicular placement of the FMT with no contact to bone and the placement of cartilage behind the FMT to create a preloaded “spring” function, and (4) 4 points of FMT fixation: a rim of the round window bony overhang left intact both anterior and posterior to the FMT, conductor link stabilization, and cartilage behind the FMT. In addition, the FMT should be covered with soft tissue. [ABSTRACT FROM AUTHOR]

Hearing is of utmost importance for normal speech and social development. Even children who have mild or unilateral permanent hearing loss may experience difficulties with understanding speech, as well as problems with educational and psycho-social development. The increasing advantages of middle-ear implant technologies are opening new perspectives for restoring hearing. Active middle-ear implants can be used in children and adolescents with hearing loss. In addition to the well-documented results for improving speech intelligibility and quality of hearing in sensorineural hearing loss active middle-ear implants are now successfully used in patients with conductive and mixed hearing loss. In this article we present a case of successful, single-stage vibroplasty, on the right side with the fixation of the FMT on the stapes and PORP CLiP vibroplasty on the left side in a 6-year-old girl with bilateral mixed hearing loss and multiple dyslalia associated with Franceschetti syndrome (mandibulofacial dysostosis). CT revealed bilateral middle-ear malformations as well as an atretic right and stenotic left external auditory canal. Due to craniofacial dysmorphia airway and (post)operative, management is significantly more difficult in patients with a Franceschetti syndrome which in this case favoured a single-stage bilateral procedure. No intra- or postoperative surgical complications were reported. The middle-ear implants were activated 4 weeks after surgery. In the audiological examination 6 months after surgery, the child showed 100 % speech intelligibility with activated implants on each side. [ABSTRACT FROM AUTHOR]

Objective: Our purpose was to evaluate the results of Vibrant Soundbridge (VSB) in conductive or mixed hearing loss. Materials and Methods: Twenty-five adult patients (29 ears) with a mixed or conductive hearing loss and various etiologies were included in this retrospective study. The preoperative ipsilateral pure tone average was 71 ± 3.0 dB, and the average bone conduction threshold was 42 ± 2.8 dB (n = 29). The transducer was placed on the long apophysis of the incus (n = 16), in the round window (n = 10) or on the stapes (n = 3). Results: No complications were noted. The bone conduction threshold remained unchanged. VSB was activated in all cases. The postoperative pure tone average without VSB was 63 ± 3.9 dB (n = 24) and with VSB in free-field condition 24 ± 2.1 dB (n = 22). Conclusions: VSB is safe and efficacious for auditory rehabilitation in conductive and mixed hearing losses. Copyright © 2011 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Objectives: Correct positioning of a floating mass transducer during middle ear implant surgery is often problematic. With the use of monitored anesthesia care (MAC), however, deep sedation is maintained during surgery, followed by conscious sedation in which the patient can respond to test questions that investigate correct device position and function. The main aim of this study was to determine whether intraoperative audiometric assessment was feasible with MAC with target-controlled infusion in vibroplasty. An additional aim was to determine whether MAC was sufficiently comfortable for patients during the procedure. Methods: The study group comprised 8 patients who underwent vibroplasty under sedation. Before suturing, audiometric assessment was done by stimulating the external auditory processor with pure tones at 0.5, 1, 2, and 4 kHz. Blood pressure, arterial oxygen saturation level, heart rate, and end tidal carbon dioxide level were monitored during the procedure and at awakening. Results: Audiometric assessment was successfully completed in all 8 patients. The selected parameters indicated that no patient experienced pain or discomfort during surgery; the absence of discomfort was confirmed 1 to 2 hours after the operation by simple questioning. Conclusions: We found MAC to be an efficient and relatively safe technique for verifying the correct coupling of the floating mass transducer with the middle ear during vibroplasty. The patients were able to respond appropriately to questions and commands; moreover, none reported having experienced pain or discomfort during the operation. [ABSTRACT FROM AUTHOR]