Adverse events associated with Vibrant Soundbridge: A MAUDE study.

OBJECTIVE: To summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. MATERIALS AND METHODS: The FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. RESULTS: Six hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). CONCLUSIONS: Despite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

Efficacy of vibrant sound bridge in congenital aural atresia: an updated systematic review.

PURPOSE: The indications of Vibrant Soundbridge (VSB) have been expanded to include patients with conductive and mixed hearing loss due to congenital aural atresia (CAA). However, the current evidence supporting the auditory outcomes of VSB is based mainly on case reports and retrospective chart reviews. Therefore, the present systematic review aims to summarize and critically appraise the current evidence regarding the safety and effectiveness of VSB in children and adult patients with CAA. METHODS: A systematic literature search retrieved studies that evaluated the outcomes of unilateral or bilateral implantation of VSB in patients with CAA. The bibliographic search was conducted in PubMed, Scopus, EBSCO, and Cochrane Central Register of Controlled Trials (CENTRAL) databases from January 2000 to December 2022. RESULTS: Twenty-seven studies were included in the present systematic review. Overall, the speech perception after VSB was good, with a mean word recognition score (WRS) score ranging from 60 to 96.7%. The mean postoperative speech recognition threshold (SRT) after implantation ranged from 20.8 to 50 dB. The effective gain was reported in 15 studies, ranging from 31.3 to 45.5 dB. In terms of user satisfaction with VSB, the included studies showed significant improvements in the patient-reported outcomes, such as the Speech Spatial and Qualities of Hearing scale and Glasgow Hearing Aid Benefit Profile. The VSB implantation was generally safe with low incidence of postoperative complications. CONCLUSION: VSB provides significant benefits to individuals with hearing loss owing to CAA, with very good subjective outcomes and a low risk of complications.

Comparison of hearing performance in patients with borderline indication for active middle ear or cochlear implants: clinical outcomes to guide preoperative counseling and decision making.

PURPOSE: The aim of the presented study was to compare the audiological benefit achieved in cochlear implant (CI) patients who, in principle, could still have been treated with an active middle ear implant (AMEI) with a group of AMEI users. METHODS: Results of 20 CI patients with a pure-tone average (PTA) of 70 dB HL prior to surgery were compared with a group of 12 subjects treated with a Vibrant Soundbridge (VSB). Pre-surgical comparison included PTA for air conduction and bone conduction, maximum speech recognition score for monosyllabic words (WRSmax), and aided monosyllabic word recognition at 65 dB SPL. One year after surgery, aided monosyllabic speech recognition score at 65 dB SPL was compared. RESULTS: Mean PTA for air conduction in the VSB group was significantly lower than in the CI group (4.8 dB, Z = - 2.011, p < 0.05). Mean PTA for bone conduction in the VSB group was also significantly lower than in the CI group (23.4 dB, Z = - 4.673, p < 0.001). WRSmax in the VSB group was significantly better than in the CI group (40.7%, Z = - 3.705, p < 0.001). One year after treatment, there was no significant difference in aided speech perception in quiet between both subject groups. CONCLUSION: Comparison of the two methods showed equivalent results for both treatments in subjects with a borderline indication. Not only pure-tone audiometry results but, particularly, speech perception scores pre-surgery should be taken into account in preoperative counseling.

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.

An easy method to determine crucial AMEI performance parameters from clinical routine data in individuals - Part 1: maximum output.

OBJECTIVE: The frequency specific maximum output (MO) of active middle ear implants is the most crucial parameter for speech intelligibility. We determined individual MO from clinical routine data in round window (RW) coupling of the Vibrant Soundbridge (VSB). DESIGN: Monocentric, retrospective analysis. STUDY SAMPLE: 68 ears implanted with the VSB at the RW were analysed. Using bone conduction and direct threshold, MO was determined for combinations of implants (VORP502, VORP503) and processors (Samba, Amadé). Coupling modes were: (A) without coupler (N = 28), (B) spherical coupler (N = 19), (C) soft coupler (N = 10) or (D) custom-made "Hannover coupler" (N = 11). RESULTS: The MO frequency dependence was similar for coupling types (A-D) with a maximum at 1.5 kHz. No differences between groups were observed, although the average MO of the soft coupler was 10 dB lower. The average MO (0.5, 1.0, 2.0, 4.0 kHz) was (A) 77.6 ± 15.0 dB HL, (B) 81.0 ± 11.1 dB HL, (C) 67.6 ± 17.9 dB HL (C), and (D) 79.6 ± 11.7 dB HL (D). CONCLUSION: The individual MO can be determined from patients' clinical data. It permits in-depth analyses of patient outcomes and definition of evidence-based indication and decision criteria.

An easy method to determine crucial AMEI performance parameters from clinical routine data in individuals - Part 2: dynamic range.

OBJECTIVE: The dynamic range (DR) available to the patient is a central parameter to determine speech intelligibility in quiet. DESIGN: In this retrospective study, the DR for the Vibrant Soundbridge implanted in individual patients was calculated using in situ thresholds of the patients and technical data of the implant system. The average DR across frequencies (0.5, 1, 2, 4 kHz) was correlated with the patients' assigned word recognition score (WRS) in quiet. STUDY SAMPLE: A data set of 66 cases (4 bilateral and 2 revised cases) from 60 implanted patients between 14.3-81.8 years were analysed. RESULTS: The relationship between DR and WRS was described by a sigmoidal growth function with R2=0.6371 and a maximum WRS (upper asymptote) of 93.5%. Word recognition scores in quiet improved with increasing DR. A significant shift in performance was detected from DR bin 2 (10-20 dB, median WRS 55%) to bin 3 (20-30 dB, median WRS 80%) and from DR bin 4 (30-40 dB, median WRS 82.5%) to bin 5 (40-50 dB, median WRS 90%). CONCLUSION: A minimum DR of 20 dB can yield sufficient speech intelligibility in quiet in implanted patients, however, an optimum DR is suggested to be 40 dB.

Middle Ear Implant Usage Restores Subjective Listening Effort toward Normal in Complex Acoustic Scenes.

INTRODUCTION: The amount of listening effort needed to understand speech in every-day life is an important outcome measure of the effectiveness of a hearing device. The main goal of this study was to assess subjective listening effort in patients implanted with an active middle ear implant Vibrant Soundbridge (VSB) with and without using their speech processor in complex acoustic scenarios. METHODS: Ten VSB users were measured using the adaptive categorical listening effort scaling (ACALES) method in four different acoustic scenarios, realized using a multichannel loudspeaker array. The four acoustic scenarios included both spatially simple and complex speech and noise arrangements that realistically simulated challenging every-day listening situations. Signal-to-noise ratios (SNRs) were adaptively varied during the measurement. Twelve normal-hearing (NH) listeners performed the same experiment as a control group. RESULTS: Listening effort was significantly reduced in all tested acoustic scenarios when participants used their VSB. When using the VSB, SNRs corresponding to mild-to-moderate listening effort were found not to be statistically different from SNRs found in the NH control group. SNRs corresponding to extreme listening effort of VSB users approached NH values, indicating partial restoration of listening effort. DISCUSSION AND CONCLUSIONS: Usage of the middle ear implant VSB was found to restore subjective listening effort to normal at high SNRs completely, and at lower SNRs partially. The remaining gap at low SNRs may be due to lower effectiveness of signal processing at high noise levels or due to the microphone location effect.

New technology can benefit established middle ear implant users: Samba 2 vs previous models of audio processors for Vibrant Soundbridge.

INTRODUCTION: The Vibrant Soundbridge (VSB) is a semi-implantable hearing aid for patients with various types of hearing loss and has been available for over 25 years. Recently, new audio processors with advanced signal processing, noise reduction, and multi-microphone technology have appeared. The aim of this study is to compare the benefits of using the newest Samba 2 processor to the previous generation processors in a group of experienced VSB users. METHODS: There were 22 experienced VSB users (mean time of using VSB was 9 years, SD = 2) who had their processor (D404 or Amadé) upgraded to the newest model (Samba 2). The mean age of the subjects was 56 years (SD = 20). Assessments were made by free-field audiometry, speech reception in quiet and noise, and Patient-Reported Outcome Measures (PROMs). RESULTS: Hearing tests in free field showed statistically significant improvements in hearing sensitivity and speech discrimination in quiet and noise with the Samba 2 audio processor compared to the earlier technology. PROMs confirmed the benefits of using the newest audio processor and there was more satisfaction in terms of usability. CONCLUSIONS: Access to modern technology for VSB patients provides measurable benefits.

Long-term outcomes of retrospective case series of middle ear implantation with Vibrant Soundbridge in children with congenital aural atresia.

PURPOSE: to assess audiological performance in quiet and noise, quality of life and side effects of Vibrant Soundbridge (VSB) in children with congenital aural atresia (CAA). METHODS: A retrospective study including consecutive patients with unilateral or bilateral CAA implanted with VSB from 2009 to 2020 in a tertiary referral centre. RESULTS: 18 patients with CAA and a present stapes were included (3 simultaneous bilateral VSB implants) and 21 ears: 17 VSB were attached to the short incus process, and four to the stapes. Age at implantation ranged from 4.7 to 15.8 years. Average follow-up was 6.5 years (± 3.7 years). In unilateral VSB, air conduction pure tone average (ACPTA) thresholds increased from 75.3 ± 15.2 to 32.6 ± 8.3 dB post-operatively (VSB activated) (n = 15; p < 0.01). The speech reception threshold (SRT) and the word recognition score (WRS) were significantly improved from 81.5 ± 10.4 to 43.9 ± 7.6 dB and 0% to 84.8 ± 8.5% postoperatively (n = 15; p < 0.01). The signal to noise ratio (SNR) was significantly improved from 2.1 ± 2.9 dB VSB inactivated to 0.3 ± 2.7 dB VSB activated (n = 15; p < 0.01). There was no significant difference in performance according to floating mass transducer (FMT) placement. 5/15 children were non-users at last follow-up in unilateral VSB and 0/3 in bilateral. CONCLUSIONS: CAA ears with VSB activated had a significant improvement of ACPTA, WRS, SRT and SNR. A third of patients with unilateral CAA became non-users at last follow-up. The main challenge is to target the indications for the implantation of the VSB to avoid its discontinuation.

Hearing rehabilitation and microbial shift after middle ear surgery with Vibrant Soundbridge in patients with chronic otitis media.

INTRODUCTION: Patients with otitis media (OM) encounter significant functional hearing impairment with conductive, or a combined hearing loss and long-term sequelae involving impaired speech/language development in children, reduced academic achievement and irreversible disorders of middle and inner ear requiring a long time therapy and/or multiple surgeries. In its persistent chronic form, Otitis media (COM) can often only be treated by undergoing ear surgery for hearing restoration. The persistent inflammatory reaction plays a major role, often caused by multi-resistant pathogens in the ear. Herein, we present outcomes of patients implanted with currently the only FDA approved active Middle Ear Implant Vibrant Soundbridge (VSB), suffering from persistent COM. METHODS: The study enrolled 42 patients, treated by performing middle ear (ME) surgery to different extents and implanted with the VSB to various structures in the ME. Included were 17 children and 25 adults that had recurrent and/or persisting OM and significant hearing loss. Preoperative and postoperative patients' audiometric data were evaluated and the benefit with VSB assessed using the Glasgow Benefit Inventory for adults and pediatric cohorts. The microbial spectrum of pathogens was assessed before and after surgery, exploring the colonization of the otopathogens, as well as the intestinal microbiome from individually burdened patients. RESULTS: The mean functional gain is 29.7 dB HL (range from 10 to 56.2 dB HL) with a significant improvement in speech intelligibility in quiet. Following VSB implantation, no significant differences in coupling were observed at low complication rates. Postoperatively patients showed significantly increased benefit with VSB compared to the untreated situation, including less otorrhea, pain, medical visits, and medication intake, with no recurrent OM and significant bacterial shift in otopathogens. The analysis of the intestinal microbiome displayed a high abundance of bacterial strains that might be linked to chronic and persistent inflammation. CONCLUSIONS: Functional ear surgery including rehabilitation with a VSB in patients suffering from COM present to be safe and effective. The successful acceptance accompanied by the improved audiological performance resulted in significant benefit with VSB, with a shift in the ear pathogens and altered microbiome and thus is a great opportunity to be treated.

Comparison between incus short process and long process coupling of the vibrant soundbridge in human temporal bones.

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

[Influence of directional microphones on listening effort in middle ear implant users]. / Einfluss von Richtmikrofonie auf die Höranstrengung bei Mittelohrimplantatträgern.

BACKGROUND AND OBJECTIVE: Besides speech intelligibility, subjective listening effort is an important outcome for the success of hearing devices and their signal processing. The aim of the present study was to determine subjective listening effort for speech in a noisy background in patients with the active middle ear implant Vibrant Soundbridge (VSB) for omnidirectional and directional microphone settings, with and without occlusion of the contralateral ear. MATERIAL AND METHODS: A total of 15 patients using a VSB were measured using the adaptive categorical listening effort scaling (ACALES) method in a ring of loudspeakers placed in an anechoic room. Different background noises from different directions and simultaneously presented sentences from the Oldenburg sentence test were combined in four different realistic acoustic scenes. RESULTS: The directional microphone program reduced median subjective listening effort only numerically compared to the omnidirectional microphone program in acoustic scenarios with diffuse noise and with low signal-to-noise ratios; however, this difference failed to reach statistical significance. When occluding the ear contralateral to the VSB, all investigated listening effort categories were measured at significantly higher signal-to-noise ratios than with access to both ears. CONCLUSION: Due to missing statistical significance in reduction of listening effort, this study delivered no recommendation for or against usage of the directional microphone program; however, reduced listening effort was shown for binaural listening in comparison to monaural listening. Therefore, patients should be encouraged to always listen with both ears for best results.

Long-Term Safety and Quality of Life after Vibroplasty in Sensorineural Hearing Loss: Short/Long Incus Process Coupler.

OBJECTIVE: The study shows the long-term effectiveness, safety, and quality of life after Vibrant Soundbridge (VSB) implantation in sensorineural hearing loss (SNHL) using the short process coupler (SP) or the long process coupler (LP). METHODS: This retrospective study evaluated 77 VSB cases. Follow-up (F/U) time-dependent objective measurements (audiological outcomes), subjective data collection (quality-of-life questionnaire), and safety measures are presented. RESULTS: Sixty-two ears were included in the analysis with up to 116 months of postsurgical F/U data (mean 32.15 ± 37.97 months LP and SP coupler). Fifty-three ears (13 bilateral cases) received the LP coupler and 9 subjects the SP coupler. The post-operative bone conduction thresholds remained stable and, in both groups, <10 dB. The benefit in word recognition scores measured at 65 dB SPL and 80 dB SPL showed no significant difference between the couplers (p = 0.559 and p = 0.088, respectively). The functional gain was not significantly different (p > 0.05) with a mean of 20.91 ± 9.77 and 17.19 ± 5.75 for LP and SP coupler, respectively. The utility score deciphered from the Assessment of Quality-of-life Questionnaire-8 dimensions revealed a mean score of 0.75 ± 0.16 which is not significantly different to the age- and sex-matched healthy control group with 0.81 ± 0.02 (p = 0.3547). CONCLUSION: The Incus Vibroplasty utilizing both couplers is a safe and effective method to treat mild-to-severe SNHL. Both fixation methods of the floating mass transducer exhibit good clinical and audiological outcomes with high patient quality of life. The SP coupling method can be a good alternative when the long process is anatomically inaccessible, or the approach is limited due to anatomical reasons.

Device failure caused by the dissociation of floating mass transducer in Vibrant SoundBridge®.

BACKGROUND: Vibrant SoundBridge® (VSB), a semi-implantable middle ear device, is one of the treatment options for patients with mild-to-severe sensorineural hearing loss or mixed hearing loss. Herein, we report delayed device failure after VSB surgery in two patients. CASE PRESENTATION: In both cases, a revision surgery was performed for the removal of the device; dissociation of the floating mass transducer (FMT) and coupler was noticed in one patient, and dissociation of the FMT-coupler complex from the short process of the incus in the other. In Case 1, the vibration-like sounds disappeared after the surgery. In Case 2, wearing bilateral hearing aids improved hearing after removal surgery, but complaints regarding speech discrimination persisted. Both cases show the importance of not loosening the connectivity between the FMT, coupler, and short process of the incus during VSB surgery. CONCLUSIONS: To our knowledge, there has been no report of dissociation from the short process of the incus or the dissociation between an FMT and the coupler.

Speech perception and hearing effort using a new active middle ear implant audio processor.

PURPOSE: The Vibrant Soundbridge (VSB) was introduced in 1996, and the fourth generation of the audio processor recently released. This clinical study evaluates the audiological performance and subjective satisfaction of the new SAMBA 2 audio processor compared to its predecessor, SAMBA. METHOD: Fifteen VSB users tested both audio processors for approximately 3 weeks. Air conduction and bone conduction thresholds and unaided and aided sound field thresholds were measured with both devices. Speech performance in quiet (Freiburg monosyllables) and noise (OLSA) was evaluated as well as subjective listening effort (ACALES) and questionnaire outcomes (SSQ12 and APSQ). In addition, data from 16 subjects with normal hearing were gathered on sound field tests and ACALES. RESULTS: Both audio processors showed substantial improvement compared to the unaided condition. The SAMBA and SAMBA 2 had comparable performance in sound filed thresholds, while the SAMBA 2 was significantly better in speech in quiet, speech in noise, reduced listening effort, and improved subjective satisfaction compared with the SAMBA. CONCLUSION: The SAMBA 2 audio processor, compared to its predecessor SAMBA, offers improved performance throughout the parameters investigated in this study. Patients with a VSB implant would benefit from an upgrade to SAMBA 2.

A New Stapes-Head Coupler for the Vibrant Soundbridge System.

INTRODUCTION: The Vibrant Soundbridge (MED-EL Medical Electronics, Austria) is an active middle ear implant with a floating mass transducer (FMT) for patients with conductive, sensorineural, or mixed hearing loss. While the FMT is vertically aligned above the stapes head (SH) with the current Vibroplasty Clip coupler (MED-EL Medical Electronics), the new SH coupler was developed to mount the FMT on the inferior side of the stapes and to fit in the reduced middle ear space after canal-wall-down mastoidectomy. METHODS: Using 11 human cadaveric temporal bones (TBs), placements of the new SH couplers on the stapes were examined, and effective stimuli to the cochlea were evaluated by measuring piston-like motion of the stapes footplate with a current of 1 mA on the FMT. The results were assessed in comparison with the Vibroplasty Clip coupler. RESULTS: The new SH coupler showed perfect coupling on the stapes in 9 out of 11 TBs. A small gap between the SH and the plate of the connection link part was unavoidable in 2 TBs but had negligible effect on vibrational motion of the stapes. Vibrational motion of the stapes with the new SH coupler was reduced at frequencies above 3 kHz compared to the corresponding motion with the current Vibroplasty Clip coupler, but the relative attenuation over all 11 cadaveric temporal bones was <10 dB. CONCLUSIONS: The new SH coupler provides an alternative with more stable fixation when placement of the current Vibroplasty Clip coupler is limited due to insufficient space after canal-wall-down mastoidectomy, while still delivering effective stimuli to the cochlea.

A retrospective European multicenter analysis of the functional outcomes after active middle ear implant surgery using the third generation vibroplasty couplers.

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.

Sound-localisation performance in patients with congenital unilateral microtia and atresia fitted with an active middle ear implant.

OBJECTIVE: This study assessed the safety and sound-localisation ability of the Vibrant Soundbridge (VSB) (Med-EL, Innsbruck, Austria) in patients with unilateral microtia and atresia (MA). METHODS: This was a single-centre retrospective research study. Twelve subjects with unilateral conductive hearing loss (UCHL) caused by ipsilateral MA were recruited, each of whom underwent VSB implantation and auricular reconstruction. The bone-conduction (BC) threshold was measured postoperatively, and the accuracy of sound localisation was evaluated at least 6 months after surgery. Horizontal sound-localisation performance was investigated with the VSB activated and inactivated, at varying sound stimuli levels (65, 70 and 75 dB SPL). Localisation benefit was analysed via the mean absolute error (MAE). RESULTS: There was no statistical difference in mean BC threshold of impaired ears measured preoperatively and postoperatively. When compared with VSB-inactivated condition, the MAE increased significantly in unilateral MA patients in the VSB-activated condition. Besides, sound-localisation performance worsened remarkably when sound was presented at 70 dB SPL and 75 dB SPL. Regarding the side of signal location, the average MAE with the VSB device was much higher than that without the VSB when sound was from the normal-hearing ear. However, no significant difference was observed when sound was located from the impaired ear. CONCLUSION: This study demonstrates that in patients with unilateral MA, the VSB device does not affect inner-ear function. Sound-localisation ability is not improved, but deteriorated at follow-up. Our results suggest that the VSB-aided localisation abilities may be related to the thresholds between the ears, plasticity of auditory system and duration of use of VSB.

Audiological Results with the SAMBA Audio Processor in Comparison to the Amadé for the Vibrant Soundbridge.

BACKGROUND: Since its introduction in 1996, the Vibrant Soundbridge (VSB) has been upgraded with several improved generations of processors. As all systems are compatible, implanted patients can benefit from new technologies by upgrading to the newest processor type available. OBJECTIVES: The aim of this study was to compare the performance of the new (current) SAMBA processor with the previous Amadé processor. METHODS: Twenty subjects monaurally implanted with a VSB and the Amadé processor tested the new SAMBA processor for a trial period of 4 weeks. We measured air conduction and bone conduction thresholds, unaided thresholds, and aided free field thresholds with both devices. Speech performance in quiet using the Freiburg monosyllabic test at 65 dB SPL (S0) was compared. The speech intelligibility in noise was determined using the Oldenburg sentence test measured in different listening conditions (S0NVSB/S0Ncontra) and microphone settings (omni/directional vs. adaptive directivity). RESULTS: Word recognition scores in quiet with the SAMBA were still significantly lower than with the Amadé after the 4 weeks trial period but improved over the following year. Speech intelligibility with the SAMBA was significantly better than with the Amadé in omnidirectional mode and comparable with the Amadé in directional mode. Hence, the adaptive directionality provides an advantage in difficult hearing situations such as noisy environments. The subjective benefit was evaluated using the Abbreviated Profile of Hearing Aid Benefit and the Speech, Spatial and Qualities-C questionnaire. Results of the questionnaires demonstrate an overall higher level of satisfaction with the new SAMBA speech processor than with the older processor. CONCLUSION: The SAMBA enables similar speech perception in quiet but more flexible adaptation in acoustically challenging environments compared to the previous Amadé processor.

The vibrating ossicular prosthesis in children and adolescents: a retrospective study.

PURPOSE: The primary objective of the retrospective study was to collect speech intelligibility data on children and adolescents implanted with the vibrating ossicular prosthesis (VORP) 503. METHODS: This was a retrospective, multicentre study on 55 children and adolescents from 6 German clinics aged between 5 and 17 years suffering from mixed or conductive hearing loss implanted with a VORP 503. Pre- and postoperative bone-conduction pure tone thresholds were measured at 0.5, 1, 2 and 4 kHz, and word recognition scores in the unaided and VORP 503-aided conditions using monosyllabic speech intelligibility tests measured at 65-dB sound pressure level (SPL) were determined. RESULTS: Mean pre- and postoperative bone-conduction thresholds remained unchanged, showing the preservation of inner ear hearing. Speech intelligibility assessed in quiet at 65-dB SPL improved on average from 24.5% (SD ± 25.4) unaided to 86.4% (SD ± 13.4) aided. The average improvement of 61.9% (SD ± 25.3) was clinically and statistically significant. A total of three complications were found in the medical records of 55 subjects. The responsible investigators judged these events as procedure related. CONCLUSION: The treatment of children suffering from conductive or mixed hearing loss with the VORP 503 implant demonstrates excellent aided benefit in terms of speech understanding and only minor complications.