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AbstractBackgroundMethodsResultsConclusionThe “floating mass transducer” (FMT) of the Vibrant Soundbridge was initially attached to the long process of the incus (LP). In patients missing an incus, coupling to the stapes head using the Vibroplasty CliP-coupler is used. Its main limitation is the height, leading to potential contact with the tympanic membrane. The new stapes head (SH)-coupler reduces the functional height but tilts the stimulation angle by 30°. We investigated the SH-coupler’s magnitude and sound transmission quality compared to the LP-coupler.Laser Doppler vibrometry was used on 10 cadaveric human temporal bones. Measurements of the stapes and round window motion were taken for electrical (FMT-) stimulation during application of both couplers.At the round window, the SH-coupler showed a significantly higher gain magnitude than the LP-coupler (+ 13.4 dB over 1023–3577Hz). At low frequencies (382–500Hz), the SH-coupler gain was significantly lower (-9.9 dB). Total harmonic distortions >10% at 100 dB HLeq were recorded in 3.4% of the SH- and 7.4% of the LP-couplers above 500 Hz.The SH-coupler’s performance exceeds the LP-coupler in middle and high frequencies and is comparable to and a good alternative to the CliP-coupler, dependent on the individual anatomy. [ABSTRACT FROM AUTHOR]

This study investigated sound localization abilities in patients with bilateral conductive and/or mixed hearing loss (BCHL) when listening with either one or two middle ear implants (MEIs). Sound localization was measured by asking patients to point as quickly and accurately as possible with a head-mounted LED in the perceived sound direction. Loudspeakers, positioned around the listener within a range of +73°/−73° in the horizontal plane, were not visible to the patients. Broadband (500 Hz–20 kHz) noise bursts (150 ms), roved over a 20-dB range in 10 dB steps was presented. MEIs stimulate the ipsilateral cochlea only and therefore the localization response was not affected by crosstalk. Sound localization was better with bilateral MEIs compared with the unilateral left and unilateral right conditions. Good sound localization performance was found in the bilaterally aided hearing condition in four patients. In two patients, localization abilities equaled normal hearing performance. Interestingly, in the unaided condition, when both devices were turned off, subjects could still localize the stimuli presented at the highest sound level. Comparison with data of patients implanted bilaterally with bone-conduction devices, demonstrated that localization abilities with MEIs were superior. The measurements demonstrate that patients with BCHL, using remnant binaural cues in the unaided condition, are able to process binaural cues when listening with bilateral MEIs. We conclude that implantation with two MEIs, each stimulating only the ipsilateral cochlea, without crosstalk to the contralateral cochlea, can result in good sound localization abilities, and that this topic needs further investigation. [ABSTRACT FROM AUTHOR]

To review the decision-making paradigm in the recommendations of BCI and aMEI overlapping candidacy for patients with conductive or mixed HL, and to determine if there are differences in hearing and quality of life outcomes between these implantable hearing devices. Retrospective data from patients receiving BCI or aMEI in the past decade were analysed. Patients were grouped into: 1. BCI candidates, 2. BCI or aMEI candidates, and 3. aMEI candidates. We compared outcomes and examined the impact of BC threshold, age at implantation, and duration of hearing loss on candidacy. 89 participants were included: 30 BCI, 37 aMEI, and 22 BCI or aMEI candidates. All groups performed similarly in aided sound field threshold testing. BCI group had lower speech scores in quiet compared to 'BCI or aMEI.' No significant differences were found in APHAB global scores. BC threshold, duration of hearing loss, and age at implantation had no significant effects. Outcomes were generally similar across groups, except for higher effective gain in the aMEI group. Our proposed patient pathway and decision-making approach facilitate candidate selection for aMEI and BCI, aiming to optimise outcomes. [ABSTRACT FROM AUTHOR]

Active bone-conducting hearing devices (aBCHD; e.g., MEDEL Bonebridge® (BB)) and active middle ear implants (aMEI; e.g., MEDEL Vibrant Soundbridge® (VSB)) use radio frequency transmission to send information from an external microphone and sound processor to an internally implanted transducer. These devices potentially have an advantage over devices with percutaneous links because the skin is closed over the implantable components, which should reduce the risk of skin problems and infection. On the other hand, surgical procedures are more complex, with a greater risk of damage due to surgery. The objectives of this research were to quantify the reliability and long-term survival of MEDEL VSB and BB devices, determine the adverse and serious adverse device-related complications, and consider associated causes. A multi-center observational retrospective and prospective study was conducted at eleven auditory implant centers in the United Kingdom. Data was collected using a surgical questionnaire and audiological reports. Data were obtained from patient notes or from prospective cases that had a minimum follow-up of one year post-implant. Consecutive patient records were reviewed. Datasets from 109 BB and 163 VSB were reviewed. Of these, 205 were retrospective case note reviews, and 67 were prospective cases. The mean follow-up was 4 and 6 years, respectively, for BB and VSB. Kaplan–Meier Survival analyses indicated that the BB survival was 97% and 93.3% at 1 and 5 years, respectively, and the VSB was 92.1% and 87% at the same time points. This is a large cohort study for the field and has indicated that BB and VSB are safe interventions. Care should be taken to monitor magnet strength in the first few months. For the majority of device-related effects, there was no apparent association with etiology. However, an interesting pattern emerged for individuals who exhibited an inflammatory response, e.g., adhesions or device extrusion, and those with a history of chronic suppurative otitis media. This should be considered in future work and is not surprising given that many VSB recipients have a complicated hearing history, often associated with otitis media. [ABSTRACT FROM AUTHOR]

Bone conduction implants (BCIs) and middle ear implants (MEIs) are promising options for individuals with persistent chronic inflammation of the middle or outer ear. However, the structure of the middle ear is often altered in patients who undergo mastoidectomy or posterior wall removal for refractory otitis media, leaving uncertainty regarding the efficacy of hearing devices. Only a few studies have examined auditory outcomes based on the etiology of hearing impairment. We investigated hearing outcomes, including speech audiometry, in patients who underwent implantation after surgery for refractory otitis media. Our findings indicated that patients who received BCIs or MEIs achieved favorable hearing outcomes. Furthermore, a correlation was observed between the preoperative bone-conduction threshold at 1 kHz in the better ear and the sound-field threshold at 1 kHz with BCIs, whereas no correlation was observed between the preoperative bone-conduction threshold and the sound-field threshold with MEIs. This study highlights the positive impact of BCIs and MEIs in patients who undergo implantation after surgery for refractory otitis media. Additionally, our study identified parameters that predict postoperative efficacy. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. 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). 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. 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. [ABSTRACT FROM AUTHOR]

Introduction: The totally implantable active middle ear implant Esteem® may be considered an effective alternative to conventional hearing aids (cHAs) to manage moderate-to-severe forms of sensorineural hearing loss. This study aimed to provide long-term comparative data of Esteem performances with those achieved by cHA., Methods: From a total of 46 subjects who received unilateral application of Esteem®, and were followed up over the years, ten underwent an audiological assessment that compared the outcomes with those achieved in the contralateral ear by a cHA, considering the initially symmetric auditory thresholds in both ears. Other than pure tone audiometry and speech audiometry in quiet, the assessment was performed by using the adaptive speech in noise, i.e., Matrix test., Results: The mean speech intelligibility in quiet shows in the unaided situation a recognition of 50.7% at 71 dBHL, 71% at 69 dBHL with only contralateral cHA, 92% at 66 dBHL with only Esteem device and 94% at 61 dBHL with Esteem® device and contralateral cHA. The mean speech intelligibility in noise shows in the unaided situation a recognition of 36% at 71 dBHL, 56% at 69 dBHL with only contralateral cHA, 79% at 66 dBHL with only Esteem® device and 84% at 61 dBHL with Esteem® device and contralateral cHA. At Matrix test in the unaided condition, 4 patients reached 50% of intelligibility and the 50% threshold was obtained with a mean sound/noise ratio of +10 dBHL. In the contralaterally aided condition, 10 patients reached a 50% threshold in a condition of mean S/N ratio of +10.6 dBHL. In the Esteem® only and Esteem® plus cHA condition, all patients reached the 50% threshold with a mean S/N ratio of +3.4 dBHL with the Esteem® device and +0.92 dBHL with Esteem® plus a contralateral cHA, with a statistically nonsignificant difference. The mean deviation from the reference value (7.1 dB in the normal hearing population) was 17.1 dBHL, in unaided situation; this condition did not change with only the contralateral cHA (17.6 dBHL), whilst a significant improvement could be identified with only Esteem® device, where the mean deviation was 10.5 dBHL, and mostly with Esteem® device associated with the contralateral cHA, with a value of 8.02 dBHL., Conclusions: The adaptive speech audiometry in noise (Matrix Test) showed that binaural stimulation provides greater benefits in the speech recognition in noise test in comparison to monaural stimulation, especially when this is carried out only by the cHA. However, the Esteem® device allowed to obtain audiological benefits that are significantly superior to those offered by cHAs, especially in cases where the hearing loss is severe and, in some cases, profound, achieving performances almost comparable to those of a cochlear implant., (© 2024 S. Karger AG, Basel.)

Sound localization in daily life is one of the important functions of binaural hearing. Bilateral bone conduction devices (BCDs), middle ear implants, and cartilage conduction hearing aids have been often applied for patients with conductive hearing loss (CHL) or mixed hearing loss, for example, resulting from bilateral microtia and aural atresia. In this review, factors affecting the accuracy of sound localization with bilateral BCDs, middle ear implants, and cartilage conduction hearing aids were classified into four categories: (1) types of device, (2) experimental conditions, (3) participants, and (4) pathways from the stimulus sound to both cochleae. Recent studies within the past 10 years on sound localization and lateralization by BCDs, middle ear implants, and cartilage conduction hearing aids were discussed. Most studies showed benefits for sound localization or lateralization with bilateral devices. However, the judgment accuracy was generally lower than that for normal hearing, and the localization errors tended to be larger than for normal hearing. Moreover, it should be noted that the degree of accuracy in sound localization by bilateral BCDs varied considerably among patients. Further research on sound localization is necessary to analyze the complicated mechanism of bone conduction, including suprathreshold air conduction with bilateral devices.

Active bone-conducting hearing devices (aBCHD; e.g., MEDEL Bonebridge® (BB)) and active middle ear implants (aMEI; e.g., MEDEL Vibrant Soundbridge® (VSB)) use radio frequency transmission to send information from an external microphone and sound processor to an internally implanted transducer. These devices potentially have an advantage over devices with percutaneous links because the skin is closed over the implantable components, which should reduce the risk of skin problems and infection. On the other hand, surgical procedures are more complex, with a greater risk of damage due to surgery. The objectives of this research were to quantify the reliability and long-term survival of MEDEL VSB and BB devices, determine the adverse and serious adverse device-related complications, and consider associated causes. A multi-center observational retrospective and prospective study was conducted at eleven auditory implant centers in the United Kingdom. Data was collected using a surgical questionnaire and audiological reports. Data were obtained from patient notes or from prospective cases that had a minimum follow-up of one year post-implant. Consecutive patient records were reviewed. Datasets from 109 BB and 163 VSB were reviewed. Of these, 205 were retrospective case note reviews, and 67 were prospective cases. The mean follow-up was 4 and 6 years, respectively, for BB and VSB. Kaplan–Meier Survival analyses indicated that the BB survival was 97% and 93.3% at 1 and 5 years, respectively, and the VSB was 92.1% and 87% at the same time points. This is a large cohort study for the field and has indicated that BB and VSB are safe interventions. Care should be taken to monitor magnet strength in the first few months. For the majority of device-related effects, there was no apparent association with etiology. However, an interesting pattern emerged for individuals who exhibited an inflammatory response, e.g., adhesions or device extrusion, and those with a history of chronic suppurative otitis media. This should be considered in future work and is not surprising given that many VSB recipients have a complicated hearing history, often associated with otitis media.

Stimulating the round window membrane via an active actuator of the middle ear implant, named the reverse stimulation, has become an option to help patients with ossicular chain deformity (OCD) to restore hearing. However, there is still no concise description of how OCD affects reverse stimulation considering the overflow characteristics of third windows. In the present study, an impedance model considering the vestibular and cochlear aqueducts was used to investigate the dynamic response of the cochlea to reverse stimulation under OCD. First, a finite-element (FE) model of the middle ear and the ear canal was used to estimate the changes in reverse middle-ear impedance caused by ossicular chain fixation and ossicular chain interruption. Then, the impedance model was used to predict the reverse transfer function, which characterizes the effect of OCD on the dynamic response of the cochlea. The results show that ossicular chain fixation reduces the reverse stimulation's performance. Moreover, the existence of the third windows complicates the effect of ossicular chain fixation on the reverse stimulation and boosts obviously the reverse stimulation's performance at low frequencies. In contrast, regardless of the existence of third windows, ossicular chain interruption enhances the effect of reverse stimulation. [ABSTRACT FROM AUTHOR]

Middle ear implants (MEI) are for the medical rehabilitation of the hearing function in case of sound conduction hearing losses as well as cochlear hearing losses and their combinations. An objective tool to reach the best fitting of the external worn sound processors is essential for patients who do not want or cannot participate in the fitting process. In addition to Laser-Doppler-Vibrometry (LDV) measurement, the sound pressure was measured distant to the eardrum to attain additional information for comparison. Three groups of patients with different middle ear characteristics were examined. Because of the large spreading of measuring results even within a patient group with similar eardrum and middle ear conditions it is difficult to develop characteristic diagrams which represent the mean values of eardrum displacements with different sound processor adjustments being the base for normative data courses. The LDV measurements can be used as a tool for fitting sound processors by finding individual maximum eardrum velocities in the frequency range 125 Hz to 8 kHz. In comparison to acoustical measurements the optical measurements have advantages concerning lower variations of measurement values, higher spectral resolution, and robustness against disturbing acoustic noise, especially at low frequencies. [ABSTRACT FROM AUTHOR]

Objective: To measure signal transmission characteristics for audio processors of an active middle ear implant as a function of skin flap thickness, i.e., distance between audio processor and the implant's receiver coil., Methods: Output sound pressure levels for 90 dB input sound pressure level (OSPL90), reference test gains as function of frequency for an input sound pressure level of 60 dB (RTG60), and reference test gains (RTG - high frequency averages) were recorded in a hearing aid test box for Samba 2 Hi, Samba 2 Lo, and AP404 audio processors (MED-EL, Innsbruck, Austria) positioned on an implant-in-the-box and distances of 0-10 mm between audio processors and the receiver coil., Results: For all audio processors, the OSPL90 and RTG decreased linearly with increasing distance. The effect was dependent on audio processor type and the strongest reduction was observed for Samba 2 Lo. Between distances of 0 mm and 10 mm, the relative change of RTG was - 9,9 dB for Samba 2 Hi, -10,3 dB for AP404, and -27,7 dB for Samba 2 Lo., Conclusions: Skin thickness is a clinically significant factor which has to be considered in VSB treatment. In combination with insufficient transducer coupling or in patients with hearing thresholds close to the indication criteria limit, a thick skin flap could lead to loss of transmitted energy resulting in insufficient audiological outcome with the active middle ear implant., (Copyright © 2024 The Author(s). Published by Elsevier GmbH.. All rights reserved.)

Purpose: Magnetic resonance imaging (MRI) is often used to visualize and diagnose soft tissues. Hearing implant (HI) recipients are likely to require at least one MRI scan during their lifetime. However, the MRI scanner can interact with the implant magnet, resulting in complications for the HI recipient. This survey, which was conducted in two phases, aimed to evaluate the safety and performance of MRI scans for individuals with a HI manufactured by MED-EL (MED-EL GmbH, Innsbruck, Austria). Methods: A survey was developed and distributed in two phases to HEARRING clinics to obtain information about the use of MRI for recipients of MED-EL devices. Phase 1 focused on how often MRI is used in diagnostic imaging of the head region of the cochlear implant (CI) recipients. Phase 2 collected safety information about MRI scans performed on HI recipients. Results: 106 of the 126 MRI scans reported in this survey were performed at a field strength of 1.5 T, on HI recipients who wore the SYNCHRONY CI or SYNCHRONY ABI. The head and spine were the most frequently imaged regions. 123 of the 126 scans were performed without any complications; two HI recipients experienced discomfort/pain. One recipient required reimplantation after an MRI was performed using a scanner that had not been approved for that implant. There was only one case that required surgical removal of the implant to reduce the imaging artefact. Conclusion: Individuals with either a SYNCHRONY CI or SYNCHRONY ABI from MED-EL can safely undergo a 1.5 T MRI when it is performed according to the manufacturer's safety policies and procedures. [ABSTRACT FROM AUTHOR]

Abstract We presented the first successful application of VSB implantation prior to auriculoplasty, which can provide hearing improvement in safe conditions and open new strategies for earlier hearing rehabilitation in unilateral microtia‐atresia children.

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Objectives: This study aimed to evaluate hearing outcomes and device safety in a large, single-surgeon experience with the totally implantable active middle-ear implants. Methods: This was a retrospective case series review of 116 patients with moderate-to-severe sensorineural hearing loss undergoing implantation of active middle-ear implants. Results: Mean baseline unaided pure tone average improved from 57.6 dB before surgery to 34.1 dB post-operatively, signifying a mean gain in pure tone average of 23.5 dB (p = 0.0002). Phonetically balanced maximum word recognition score improved slightly from 70.5 per cent to 75.8 per cent (p = 0.416), and word recognition score at a hearing level of 50 dB values increased substantially from 14.4 per cent to 70.4 per cent (p < 0.0001). Both revision and explant rates were low and dropped with increasing surgeon experience over time. Conclusion: This study showed excellent post-operative hearing results with active middle-ear implants with regard to pure tone average and word recognition score at a hearing level of 50 db. Complication rates in this case series were significantly lower with increasing experience of the surgeon. Active middle-ear implants should be considered in appropriate patients with moderate-to-severe sensorineural hearing loss who have struggled with conventional amplification and are good surgical candidates. [ABSTRACT FROM AUTHOR]

Patients' satisfaction with the device is as important as the audiological gains in patients using these devices. In this study, we aimed to evaluate the hearing aid satisfaction of individuals using The Vibrant Sound Bridge (VSB) (Vibrant Med-El, Innsbruck, Austria) and to compare this result with audiologic results ​​with and without devices. Patients who were using VSB were included in the study. Preoperative and postoperative pure tone averages and demographic datas of the patients to be included in the study were recorded. A shortened version of Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire, was used to evaluate patients' device satisfaction. Fifteen patients with VSB were included in the study. The mean follow-up was 9.13 years. The preoperative air conduction threshold and the air-bone gap in all frequencies were significantly higher than postoperative values (p <.05). The functional gain was found as 28 dB. In the APHAB questionnaire, there was a significant difference between total score results and EC, BN, RV subscales in the patients using the device (p <.01). Patients with VSB give satisfactory results in auditory gains. In particular, good indication and long-term use of the device increases the suitability and satisfaction of the patients. [ABSTRACT FROM AUTHOR]

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The aim of the present study is to report the outcomes of round window reinforcement surgery performed with the application of a Vibrant Soundbridge middle ear implant (VSB; MED-EL) in a patient with superior semicircular canal dehiscence (SSCD) who presented with recurrent vertigo, Tullio phenomenon, Hennebert's sign, bone conduction hypersensitivity, and bilateral moderate to severe mixed hearing loss. Vestibular evoked myogenic potentials (VEMPs) and high-resolution computed tomography (HRCT) confirmed bilateral superior semicircular canal dehiscence while this was not seen in magnetic resonance imaging. The surgical procedure was performed in the right ear as it had worse vestibular and auditory symptoms, a poorer hearing threshold, and greatly altered HRCT and VEMPs findings. With local-assisted anesthesia, round window reinforcement surgery (plugging) with perichondrium was performed with simultaneous positioning of a VSB on the round window niche. At the one and 3 months follow-up after surgery, VSB-aided hearing threshold in the right ear improved to mild, and loud sounds did not elicit either dizziness or pain in the patient.

Background: Previous studies in the field of cochlear implantation have proven that the use of electro-acoustic stimulation systems in patients with low frequency residual hearing results in improved speech perception scores compared to electric only stimulation. Unfortunately, many patients cannot use these systems because of inflammatory responses to the external ear piece of the system. In these cases, the substitution of low frequency acoustic stimulation through an external ear piece by mechanical stimulation with a middle ear implant could be a way to take advantage of the remaining residual hearing. Case: We report on a patient who was bilaterally implanted with a MED-EL Vibrant Soundbridge. After 12 years, her hearing loss had progressed such that she was acoustically indicated for electro-acoustic stimulation. Since she could not wear an external ear piece due to medical reasons, she was then implanted with a cochlear implant in addition to her middle ear implant on the right-hand side, hence benefitting from electro-mechanical stimulation in the right ear. For the follow-up period of 12 month her hearing loss was found stable, and speech perception results were satisfying. Conclusion: The ipsilateral use of a Vibrant Soundbridge in addition to a cochlear implant was found to be a feasible and save option for providing electro-mechanical auditory stimulation. Speech performance results comparable to electro-acoustic stimulation patients can be expected for patients with substantial low frequency residual hearing.

The aim of the present study is to report the outcomes of round window reinforcement surgery performed with the application of a Vibrant Soundbridge middle ear implant (VSB; MED-EL) in a patient with superior semicircular canal dehiscence (SSCD) who presented with recurrent vertigo, Tullio phenomenon, Hennebert's sign, bone conduction hypersensitivity, and bilateral moderate to severe mixed hearing loss. Vestibular evoked myogenic potentials (VEMPs) and high-resolution computed tomography (HRCT) confirmed bilateral superior semicircular canal dehiscence while this was not seen in magnetic resonance imaging. The surgical procedure was performed in the right ear as it had worse vestibular and auditory symptoms, a poorer hearing threshold, and greatly altered HRCT and VEMPs findings. With local-assisted anesthesia, round window reinforcement surgery (plugging) with perichondrium was performed with simultaneous positioning of a VSB on the round window niche. At the one and 3 months follow-up after surgery, VSB-aided hearing threshold in the right ear improved to mild, and loud sounds did not elicit either dizziness or pain in the patient. [ABSTRACT FROM AUTHOR]

The paper investigates periodic solutions of a nonlinear model of the middle ear with a floating mass transducer. A multi degree of freedom model is used to obtain a solution near the first resonance. The model is solved analytically by means of the multiple time scales method. Next, the stability of obtained periodic solutions is analysed in order to identify the parameters of the floating mass transducer that affect the middle ear dynamics. Moreover, some parameters of the middle ear structure are investigated with respect to their impact on obtained periodic solutions. [ABSTRACT FROM AUTHOR]

Purpose: This paper reports the surgical and audiological outcomes of a large series of patients who received a fully implantable middle ear implant (MEI): carina (Cochlear, Australia). Methods: This is a multicentre retrospective study involving three tertiary referral centres. Patient data were collected for the first 42 consecutive patients who were fitted with the MEI between 2014 and 2019 (Sheffield from February 2017 to January 2019; São Paulo from April 2015 to September 2017; Porto from December 2014 to May 2017). The main outcome measures included surgical results, free field speech testing with speech recognition thresholds (SRT) and audiological gain. Results: There was one major complication due to infection resulting in a brain abscess and explantation of the device. Three other patients had minor skin infections; no other complications were reported. Results show a functional gain of 19.5 dB (p < 0.05) with the MEI versus unaided condition. SRT improved from 57.4 dB to 44.6 dB with the MEI (p < 0.05). Conclusions: This fully implanable active MEI offers a reliable option for patients with moderate-to-severe sensorineural or mixed hearing losses especially for those do not tolerate or cannot use conventional hearing aids. It provides significant improvement in hearing as shown in the audiological outcomes. The surgery is relatively straightforward but there is a steep learning curve. The devices are well tolerated by all patients. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this work was to study the effect of middle ear disorder on round window (RW) stimulation, so as to provide references for the optimal design of RW stimulation type middle ear implants (MEIs). Methods: A human ear finite-element model was built by reverse engineering technique based on micro-computed tomography scanning images of human temporal bone, and was validated by three sets of comparisons with experimental data. Then, based on this model, typical disorders in otosclerosis and otitis media were simulated. Finally, their influences on the RW stimulation were analyzed by comparison of the displacements of the basilar membrane. Results: For the otosclerosis, the stapedial abnormal bone growth severely deteriorated the equivalent sound pressure of the RW stimulation at higher frequencies, while the hardening of ligaments and tendons prominently decreased the RW stimulation at lower frequencies. Besides, among the hardening of the studied tissues, the influence of the stapedial annular ligament's hardening was much more significant. For the otitis media, the round window membrane (RWM)'s thickening mainly decreased the RW stimulation's performance at lower frequencies. When the elastic modulus' reduction of the RWM was considered at the same time especially for the acute otitis media, it would raise the lower-frequency performance of the RW stimulation. Conclusions: The influence of the middle ear disorder on the RW stimulation is considerable and variable, it should be considered during the design of the RW stimulation type MEIs. [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]

BACKGROUND: The 20% of the hearing aid's users are not complete satisfied, for this reason it is very important to consider other treatment options. OBJECTIVE: To present preliminary results of the treatment of sensorineural hearing loss with the middle ear implant Vibrant Soundbridge. MATERIAL AND METHOD: An observational, descriptive and cross-sectional study was done from January 1st 2017 to May 2018, with patients with bilateral moderate-severe sensorineural hearing loss, and despite of hearing aid presented poor discrimination to the voice, recurrent infectious pathology of external ear or occlusion sensation. The following studies were performed pre and postoperatively: audiometry logoaudiometry, tympanometry, functional gain and social utility index. RESULTS: There were included five patients. Functional gain of 8.5 dB was obtained with the use of the implant Vibrant Soundbridge, when compared with the conventional hearing aid, as well as better social utility index (11.7%) than with the use of auditory aids. CONCLUSIONS: Middle ear implants are an alternative treatment for patients with sensorineural hearing loss who do not benefit from the use of conventional hearing aids or who, due to medical reasons, can not use them. It provides better tonal gain and better word discrimination than conventional hearing aids. [ABSTRACT FROM AUTHOR]

Objective: Identify factors associated with benefit of middle ear implants (MEIs) as compared to conventional hearing aids (HAs).Study Design: Independent review of audiological data from a multicenter prospective U.S. Food and Drug Administration (FDA) clinical trial. Preoperative and postoperative earphone, unaided/aided/implanted pure-tone thresholds, and word recognition scores were evaluated.Results: Ninety-one subjects were included in this study. Mean word recognition was better with MEIs than with HAs (81.8% ± 12.0% vs. 77.6% ± 14.6%, P = 0.035). Word recognition with MEIs showed a low positive correlation with word recognition measured with earphones (r = 0.25, P = 0.016) and a moderate positive correlation with aided word recognition (r = 0.42, P < 0.001). Earphone word recognition alone was not predictive of MEI benefit over HA benefit (r = 0.09, P = 0.41), unlike differences between scores with earphone and HAs (earphone-aided differences [EAD]) (r = 0.62, P < 0.011). As compared to those with -EADs, subjects with +EADs showed greater improvement in word recognition from unaided to implanted and from HAs to implanted (P < 0.0001). Using the 95% CI for word recognition scores, 16 subjects showed significantly higher scores with the MEI than with HAs. Of those, 14 had +EAD.Conclusion: Word recognition benefit derived from conventional HAs and MEIs from this large, multi-center FDA trial provides further evidence of the importance of aided word recognition in clinical decision making, such as determining candidacy for and success with MEIs.Level Of Evidence: 2b. Laryngoscope, 128:2133-2138, 2018. [ABSTRACT FROM AUTHOR]

Objective: Chronic obstructive inflammation of the external ear canal after different kinds of surgeries often leads to restenosis. There are different approaches to treatment of such cases, and one solution is a middle ear implant. Here we analyze the efficacy of using the Vibrant Soundbridge middle ear implant with a new incus short process (SP) coupler in this type of case. Materials and Methods: We present a case study of a 29-year old patient with bilateral mixed hearing loss caused by bilateral obstructive inflammation of the external ear canals. He had undergone meatoplasty with very short-lived improvement. Afterwards he qualified for middle ear implantation to restore hearing, and the Vibrant Soundbridge was implanted with a new SP coupler to which the floating mass transducer (FMT) is attached. Postoperative hearing tests included pure tone audiometry, free field audiometry, speech recognition, and APHAB questionnaire. Results: Speech recognition after implantation improved to 100%. Pre- and postoperative bone conduction thresholds were unchanged. Vibrometry thresholds 10 months after surgery did not deteriorate. There was a decrease in global APHAB score by 61% from 2 to 10 months after implantation. Conclusion: Application of the Vibrant Soundbridge middle ear implant can be an effective treatment in cases of hearing loss caused by obstructive inflammation of the external ear canals. The new incus SP coupler seems to be an effective method of stimulating the middle ear in mixed hearing loss. [ABSTRACT FROM AUTHOR]

Objective: To report a novel management strategy for mixed hearing loss in advanced otosclerosis. Methods: A 50-year-old male was referred to St Thomas’ Hearing Implant Centre with otosclerosis; he was no longer able to wear conventional hearing aids because of recurrent otitis externa. The patient underwent short process incus vibroplasty (using the Med-El Vibrant Soundbridge device), followed at a suitable interval (six weeks) by stapes surgery. The main outcome measures were: pure tone audiometry, functional gain and monosyllabic word recognition scores. Results: Post-operative pure tone audiometry showed a reduction of the mean air–bone gap from 55 dB HL to 20 dB HL. The residual mixed hearing loss was rehabilitated with the Vibrant Soundbridge, with an average device gain of 32 dB. The monosyllabic word recognition scores in quiet at 65 dB improved from 37 to 100 per cent when using the Vibrant Soundbridge at six months after switch-on of the device. Conclusion: Stapedotomy in conjunction with incus short process vibroplasty (i.e. inner-ear vibroplasty) is a safe and promising procedure for managing advanced otosclerosis with mixed hearing loss in selected patients. [ABSTRACT FROM AUTHOR]

Objectives/hypothesis: To evaluate the speech perception of the Ototronix MAXUM middle ear implant relative to the cochlear potential for speech perception of patients.Study Design: Clinical study chart review.Methods: We performed an evaluation of data from a prospective clinical study of 10 MAXUM patients. Primary outcome measures included comparison of word recognition (WR) scores with MAXUM (WRMAXUM ) versus word recognition under inserts (WRinserts ), and the functional gain improvement for pure-tone average (PTA) (0.5, 1, and 2 kHz) and high-frequency pure-tone average (2, 3, and 4 kHz).Results: Ten ears in 10 adult patients (six female; average age 68.7 years) were included. The average speech perception gap (difference between WRinserts and WRMAXUM ) with MAXUM was -9.2% (range, -26% to 4%). A negative number indicates that WRMAXUM was higher than the WRinserts . The average PTA with MAXUM was 23.1 dB (range, 18.7-30 dB), a 38.0-dB gain over the preoperative unaided condition (range, 20-53.3 dB). The average high-frequency pure-tone average with MAXUM was 34.4 dB (range, 26-43.3 dB), a 42.8-dB gain over the preoperative unaided condition (range, 32.3-58.7 dB).Conclusions: These data demonstrate that a significant, very strong correlation was observed between WRinserts and WRMAXUM scores (r = 0.86, P = .001), and a patient's WRinserts score may be used to reasonably predict the word recognition outcomes with MAXUM.Level Of Evidence: 4. Laryngoscope, 128:456-460, 2018. [ABSTRACT FROM AUTHOR]

Abstract Introduction The complaints associated with the use of conventional amplifying hearing aids prompted research at several centers worldwide that ultimately led to the development of implantable devices for aural rehabilitation. Objectives To review the history, indications, and surgical aspects of the implantable middle ear hearing devices. Data Synthesis Implantable hearing aids, such as the Vibrant Soundbridge system (Med-El Corporation, Innsbruck, Austria), the Maxum system (Ototronix LLC, Houston, Texas, United States), the fourth-generation of Carina prosthesis (Otologics LLC, Boulder, Colorado, United States), and the Esteem device (Envoy Medical Corporation - Minnesota, United States), have their own peculiarities on candidacy and surgical procedure. Conclusion Implantable hearing aids, which are currently in the early stages of development, will unquestionably be the major drivers of advancement in otologic practice in the 21st century, improving the quality of life of an increasingly aged population, which will consequently require increased levels of hearing support.

Objectives/hypothesis: The purpose of this study was to measure the degree of coupling between the floating mass transducer (FMT) and the round window membrane (RWM) in patients with conductive and mixed hearing loss implanted with the Vibrant Soundbridge (VSB) device. The efficiency of direct and indirect coupling of the FMT to the RWM was compared by measuring differences between the initial prescription targets and the final settings of the VSB audio processor after fine-tuning.Study Design: Retrospective study.Methods: Investigation of a group of subjects with either conductive or mixed hearing loss implanted with the VSB, a device that uses a FMT coupled to the RWM. There were two subgroups: subjects in which coupling was direct (no interposed material) or indirect (interposed material). The functional gain, insertion gain, and compression characteristics of the device were measured to assess the efficiency of coupling and to investigate the proximity of the fitting to prescriptive targets.Results: Coupling for the subgroup with indirect coupling of the RWM was higher (better) than for the subgroup with direct coupling. The gain deviation from prescriptive targets was smaller for the subgroup with indirect coupling.Conclusions: The coupling method can have an effect on the coupling efficiency and the final electroacoustic settings of the device. The prescription targets were not accurate for the majority of subjects from either subgroup. Indirect coupling appears to provide more effective stimulation of the cochlea.Level Of Evidence: 4. Laryngoscope, 127:2843-2849, 2017. [ABSTRACT FROM AUTHOR]

Objective:To present a historical overview of the Vibrant Soundbridge®(VSB) middle ear implant (MEI), since its beginning in the 1990s to date and to describe its course and contemplate what it might become in the future. History:MEIs started to take form in researchers’ mind in the 1930s with the first experiment of Wilska. In the 1970s, several devices, such as the Goode and Perkins’, the Maniglia’s, or the Hough and Dormer’s were created but remained prototypes. It is only in the 1990s the devices that emerged remained on the market. In 1994, Symphonix, Inc. was created and aimed to manufacture and commercialize its semi-implantable MEI, the VSB. The principle of the VSB lies on a direct drive of the sound to a vibratory structure of the middle ear through an electromagnetic transducer, the floating mass transducer (FMT). The particularity of the system VSB is the simplicity of the transducer which is made of both the magnet and the coil; thus, the FMT, fixed on a vibrating middle ear structure, mimics the natural movement of the ossicular chain by moving in the same direction. The goal of the VSB was to give an alternative to patients with mild-to-severe sensorineural hearing loss who could not wear hearing aids (HAs) or who were unsatisfied conventional HA users. Subsequent to Tjellström’s experiment in 1997, implantations started to include etiologies such as otosclerosis, radical mastoidectomy, failed ossiculoplasty/tympanoplasty, and atresia. Nowadays, the VSB, with more than 20 years of experience, is the oldest and most used middle ear implant worldwide. It is well acknowledged that the straightforward design and reliability of the transducer have certainly contributed to the success of the device. [ABSTRACT FROM PUBLISHER]

Background: Partially implantable active middle ear implants (aMEIs) offer a solution for individuals who have mild to severe sensorineural hearing loss and an outer ear medical condition that precludes the use of hearing aids. When otherwise left untreated, individuals report a lower quality of life, which may further decrease with increasing disability. In the lack of cost-effectiveness studies and long-term data, there is a need for decision modeling.Objective: To explore individual-level variance in resource utilization patterns following aMEI implantation.Methods: A Markov model was developed and analyzed as microsimulation to estimate the incremental cost utility ratio (ICUR) of partially implantable aMEIs compared with no (surgical) intervention in individuals with sensorineural hearing loss and an outer ear medical condition in Australia. Cost data were derived mostly from the Medicare Benefit Schedule and effectiveness data from published literature. A third-party payer perspective was adopted, and a 5% discount rate was applied over a 10-year time horizon.Results: Compared with baseline strategy, aMEIs yielded an incremental cost of Australian dollars (AUD) 13,339.18, incremental quality-adjusted life-year (QALY) of 1.35, and an ICUR of AUD 9,913.72/QALY. Of the respective number of simulated patients who visited each health state, 75.73% never had a minor adverse event, 99.82% did not experience device failure, and 97.75% did not cease to use their aMEIs. Probabilistic sensitivity analyses showed the ICUR to differ by only 0.95%.Conclusions: In the Australian setting, partially implantable aMEIs offer a safe and cost-effective solution compared with no intervention and are also well accepted by users. [ABSTRACT FROM AUTHOR]

Objectives/hypothesis: We compared the audiologic benefits of active middle ear implants with those of passive middle ear implants with hearing aids in mixed hearing loss, and also compared the outcomes of stapes vibroplasty with those of round window vibroplasty.Study Design: Retrospective chart review.Methods: Thirty-four patients with mixed hearing loss due to chronic otitis media were treated with a middle ear implant. Of these, 15 were treated with a passive middle ear implant (conventional ossiculoplasty with a partial ossicular replacement prosthesis), nine with an active middle ear implant coupling to the stapes, and 10 with an active middle ear implant coupling to the round window. Patients underwent pure-tone/free-field audiograms and speech discrimination tests before surgery and 6 months after surgery, and the results of these tests were compared.Results: The active middle ear implant resulted in better outcomes than the passive middle ear implant with hearing aids at mid to high frequencies (P < .05). Patients who received either a stapes vibroplasty or a round window vibroplasty showed comparable hearing gain except at 8,000 Hz (48.9 dB vs. 31.0 dB, P < .05). Patients who received a stapes vibroplasty showed an improvement even in bone conduction at 1,000 Hz and 2,000 Hz (both P < .05).Conclusions: Active middle ear implantation could be a better option than treatment with passive middle ear implants with hearing aids for achieving rehabilitation in patients with mixed hearing loss. Vibroplasty via either oval window or round window stimulation shares similar good results.Level Of Evidence: 4 Laryngoscope, 127:1435-1441, 2017. [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]