Systematic review and meta-analysis of audiological and patient-reported outcomes with the VIBRANT SOUNDBRIDGE active middle ear implant
Technology Assessment, BU Vibrant
M00726_1.2 (May 2022)
Foreword
ᐅ From here on the shortened product name SOUNDBRIDGE will be used in this document.
Twenty-five years after its first implantation, the VIBRANT SOUNDBRIDGE still leads the field of active middle ear implants. Researchers all around the globe have thoroughly investigated the implant’s safety and effectiveness, leading to hundreds of peer-reviewed publications. With this growing body of evidence, however, keeping track of the bigger picture becomes more challenging. This Whitepaper provides an overall perspective by listing publications available up to December 2019 and summarizing the most commonly reported outcomes. It comes in a browser-based format, which makes it accessible anywhere at any time via https://go.medel.pro/OutcomesVSB. Designed as a ‘living document’ it will be updated regularly, while the URL will permanently link to the most recent version and can be shared or bookmarked on any digital platform.
Executive Summary
Background: Active middle ear implants (aMEIs) fill an important gap between acoustic hearing aids and cochlear implants. The SOUNDBRIDGE system was the first aMEI on the market and still leads the field after 25 years*. It consists of an audio processor and an implant (Figure 1.1). While the floating mass transducer (FMT) of the implant is attached to the ossicular chain or to a cochlear window in the middle ear, the main body of the implant is embedded below the skin right behind the ear. The audio processor is worn externally and held in place over the implant by gentle magnetic attraction. Within the EU, EFTA and countries accepting the CE mark, the SOUNDBRIDGE system is indicated for:
ᐅ Visit MED-EL’s Indications homepage for a detailed list of eligibility criteria.
- Patients aged 5 years or older with mild to severe sensorineural hearing loss (i.e., hearing loss resulting from inner ear pathologies) when acoustic hearing aids are contraindicated.
- Patients aged 5 years or older with conductive hearing loss (i.e., hearing loss resulting from middle ear pathologies), including mixed hearing loss (i.e., when both conductive and sensorineural hearing loss are present).
Goal:
This Whitepaper summarizes audiological and patient-reported outcomes associated with the SOUNDBRIDGE that have been published in the medical literature between January 1997 and December 2019. The goal is to provide:
- A comprehensive overview on the scientific literature published on the SOUNDBRIDGE.
- A quantitative analysis of the overall benefit and variation in selected clinical outcomes.
- An online platform to explore summarized outcomes.
Methods: Based on a systematic literature review, clinical outcomes from 219 primary publications were included and plotted as raw mean unaided/aided or improvement scores. From a subset of 72 publications, meta-analyses were conducted to estimate pooled mean scores across publications. Mixed models and model selection were used to explore the effects of potential demographic and clinical predictors on each outcome.
Results:
Both, the raw means and pooled estimates from meta-analyses consistently indicated similar average outcomes and levels of variation among studies. Specifically, the results of the meta-analyses were:
- Sound-field hearing thresholds: The average aided threshold was estimated at 34.6dB HL (95% CI: 32.4-36.8). The average benefit (i.e. functional gain) was estimated at 33.9dB HL (95% Ci: 30.5-37.3).
- Word recognition score at 65dB SPL (WRS65): The average aided score was estimated at 79.6% (95% CI: 76.4-82.9).
- Speech recognition threshold in noise (SRT50N): The average improvement was estimated at 5.1 dB SNR (95% CI: 3.9-6.2).
- Abbreviated Profile of Hearing Aid Benefit (APHAB) questionnaire: The average aided score was estimated at 30.8% frequency of problems (95% CI: 23.2-38.5).
- Daily use of the audio processor: The average daily use was estimated at 11.9 hours (95% CI: 8.3-15.4)
Overall, pediatric patients and patients with pure conductive hearing loss were associated with better aided results in sound-field hearing thresholds and WRS65 compared to adults and SNHL or MHL patients. The coupling location of the FMT had no effect on any outcome summarized here, thus highlighting the surgical flexibility of the SONDBRIDGE system. In speech audiometry, the type of speech test (monosyllabic vs bisyllabic) had an effect on aided word recognition score. Speech in noise measurements indicated outcomes continuing to improve over F/U times of up to 3 years.
Conclusion:
Taken together, the reviewed literature on the SOUNDBRIDGE provides compelling evidence for:
- Long-term hearing improvement, by means of hearing thresholds, speech in quiet and speech in noise tests.
- Measurable benefit in hearing-related quality of life.
- High wearing comfort and patient satisfaction, as measured by daily use.
*25 years from the first implantation within a clinical trial.
Please cite this Whitepaper as follows: VIBRANT Technology Assessment Team. Systematic review and meta-analysis of audiological and patient-reported outcomes with the VIBRANT SOUNDBRIDGE active middle ear implant. MED-EL, 2021. Version 1.2 (May 2022). URL: https://go.medel.pro/OutcomesVSB
1 Introduction
Many health-care systems around the globe are facing limited resources due to increasing health-related demands,1–3 particularly in light of aging population and innovative health technologies. More than ever, payers and providers need to rely on robust evidence summaries for informed coverage and care-protocol decisions.3 Medical device manufacturers can assist in this process by providing lay summaries of clinical evidence, which need to be both scientifically rigorous as well as readable to a diverse target audience. This Whitepaper aims to capture information from the entire body of audiological and patient-reported evidence on the SOUNDBRIDGE that was available up to December 2019 (Figure 1.1). It does not cover the full spectrum of tests and questionnaires used, but provides a quantitative analysis of outcomes that were most commonly reported by the scientific community.
Figure 1.1: The SOUNDBRIDGE system, consisting of SAMBA2 audio processor, VORP503 implant and a set of couplers for various attachment options. The loupe view shows the enlarged Floating Mass Transducer (FMT).
1.1 Historical overview
ᐅ The first SOUNDBRIDGE - at that time branded Symphonix - was implanted in 1996 by Prof. Ugo Fisch in Zürich, Switzerland.
Active middle ear implants (aMEIs) were first developed in the 1990s4 and were originally designed to overcome sensorineural hearing loss (SNHL) when acoustic hearing aids are contra-indicated due to medical conditions. aMEIs bypass the outer ear and directly stimulate the ossicular chain with mechanical energy (watch video How does the SOUNDBRIDGE work?). The audiological indication for the SOUNDBRIDGE was initially restricted to AC thresholds equal to or better than 65dB in the low frequencies and equal to or better than 85dB in the high frequencies (Figure 1.2A). Following the seminal work of Colletti,5,6 Dumon7,8 and Beltrame,9 the indication for the SOUNDBRIDGE was extended to include conductive and mixed hearing loss (C/MHL) in adults in 2007,10 thus opening this treatment option to patients suffering from hearing loss associated with atresia/microtia and other middle ear pathologies (otosclerosis, chronic otitis media, cholesteatoma, etc.). In this patient population the audiological criteria were limited to BC thresholds equal to or better than 45dB in the low frequencies and equal to or better than 65dB in the high frequencies (Figure 1.2B). In 2009, the SOUNDBRIDGE indication was extended to include subjects younger than 18 years of age and since 2014 includes children aged 5 years or older in the EU, EFTA and countries accepting the CE mark.11 For a detailed list of eligibility criteria, please refer to MED-EL’s Indications homepage.
Extending the indication range resulted in a demand for more surgical flexibility when coupling the FMT to the desired middle-ear structure, especially in patients with a history of repeated middle-ear surgeries. Coupling the FMT to the stapes or directly to the round window membrane became viable alternatives in patients with eradicated middle-ear cavities or congenital deformations. MED-EL subsequently developed a range of Vibroplasty couplers (see Figure 1.1) that facilitate the coupling process and can increase coupling efficiency. Watch this video for an overview on available couplers or refer to the Information for surgeons brochure to learn how each coupler can be used in the context of different vibroplasty approaches.
To find out more about the SOUNDBRIDGE system visit the Product homepage or explore even more free resources on the MED-EL Professionals homepage.
Figure 1.2: Audiological criteria for (A) SNHL and (B) C/MHL indications.
2 Methods
2.1 Systematic review
Three parallel search strategies (see Appendix A) for the National Library of Medicine literature database (PubMed) were set up to identify articles investigating the SOUNDBRIDGE. Following a first search in April 2013 that identified articles published from January 1997, the search terms were set up to generate weekly PubMed alerts from then on. New articles that reported on any SOUNDBRIDGE topic were added to the pool of papers. Articles unrelated to the device were excluded and not further categorized. Additional articles identified by manual search were added to the pool as well. Articles identified up to December, 31st 2019 were included for analyses in this report.
Titles, abstracts and full texts were screened against inclusion/exclusion criteria (as specified in Table 2.1) at the same time as new articles were being added to the pool. All screening steps were conducted by two independent reviewers and discrepancies were resolved upon discussion. The list of included publications is reported in Appendix A2. The following parameters were extracted: 1) Demographic parameters, including sample size, mean age, type of hearing loss, FMT coupling location, uni-/bilateral implantation. 2) Study design parameters, including time to activation, time to outcome measurements (F/U time), cohorts, subgroups and comparators. 3) Audiological outcomes, including sound-field (SF) hearing thresholds (PTA4), speech recognition thresholds in noise (SRT50N) and word recognition scores in quiet at 65dB (WRS65). 4) Patient-reported outcome measures (PROMs), including hearing-related or general quality of life questionnaires. Hearing thresholds were extracted as pure-tone average over 4 frequencies (PTA4). Continuous numerical parameters were extracted as mean (+/-SD) for overall cohort and/or subgroup cohorts if available. In some cases, data were extracted from figures using WebPlotDigitizer v4.412. If raw data were available, mean values (+/-SD) were calculated. In some cases, mean (+/-SD) were provided by the authors upon request. Data were extracted by one reviewer and checked by a second. In cases of disagreement, the respective paper was checked by a third reviewer and consensus was achieved through discussion.
| Inclusion criteria | Exclusion criteria | |
|---|---|---|
| Population | All ages, etiologies or hearing loss types | Preclinical (animal) or temporal bone studies |
| Intervention | VIBRANT Soundbridge | None |
| Comparators | Unaided or aided with any other hearing device | None |
| Outcome | Audiometric tests; Patient-reported outcomes; Daily use | Technical outcomes, surgical and/or safety outcomes |
| Study design | All publications reporting on primary data | Publication reporting on secondary data, reviews, letter, commentary |
2.2 Data analysis
The data extracted from publications was tabulated into Excel spreadsheets and further processed within the R computational environment13 and RStudio IDE.14 Random-effects meta-analysis was performed when two or more samples (cohorts) reported mean and standard deviations (SD) for any specific outcome. Meta-analyses were performed with the metafor15 package for R. Separate meta-analyses were conducted for unaided, aided or improvement scores. For aided scores, raw means were used as effect size. For improvement scores, raw mean change was used as effect size. The Restricted Maximum Likelihood Estimator (RMLE) was used to estimate the amount of heterogeneity. Funnel plots and regression test for funnel plot asymmetry were used to detect signs of heterogeneity and potential publication bias. Influential case diagnostics based on Cook’s distance criterion was applied to identify outlier studies that had a significant effect on the model fit. Once detected, influential studies were excluded to achieve a more robust model fit whenever 10 or more samples (cohorts) remained in the model after exclusion. When the sample size fell below 10 studies, the power of influential case diagnostics was considered low and all studies were kept in the model.
Model selection based on the corrected Akaike information criterion (AICc) and multi-model inference was used to investigate the relative importance of demographic and clinical predictors (confounding variables) on the respective outcome under investigation. Specifically, for n predictors, separate models including combinations of 0 to n predictors were calculated and ranked by their AICc value using the R package glmulti.16 For each predictor, the model-averaged importance (relative importance) corresponds to the sum of weigths for the models in which the predictor appears.17
Subgroup meta-analyses were performed by including categorical predictors into the respective model one at a time. Only cohorts reporting on pre-defined subgroup levels were included into the model. Cohorts reporting on pooled means for two or more levels (e.g. mean outcome pooled for CHL and MHL patients) were excluded to prevent masking of the true effect. Meta-regression was used to investigate the effect of numerical predictors (e.g. F/U time) on the respective outcome.
The goal of systematic literature reviews is to derive general conclusions based on the aggregation of available data. For quantitative data, meta-analysis is the appropriate statistical tool to summarize outcomes from multiple studies. In short, meta-analysis can quantify the overall (pooled) outcome, the variability among studies and the potential influence of other variables on the outcome under investigation.
Random Effects Model: Is one type of meta-analysis that is particularly suitable to analyze data that were not necessarily sampled from one single population.
Forest Plot: Is the preferred graph type for displaying the results of meta-analyses. It allows for an intuitive overview of outcomes from single studies and highlights the pooled outcome in the bottom line.
Confidence Interval: Margins of confidence (95%) for capturing the true mean.
Prediction Interval: Tells you that the mean outcome of any further study will fall within these limits in 95 out of 100 cases.2.3 Figures and layout
This document was written in R Markdown language using the R packages bookdown18 and knitr.19 The following R packages were used for processing data and creating figures: ggbeeswarm,20 ggplot2,21 ggpubr,22 glmulti,16 kableExtra,23 lubridate,24 magrittr,25 plotly,26 readxl,27 stringr,28 tidyverse.29 Forest plots were generated with a function from the R package meta.30 Flowcharts were rendered in Adobe Illustrator v23.0.3.
3 Results
3.1 Publication overview
Figure 3.1: Flowchart illustrating the number of articles throughout the screening process. ‘-’ = not reported
The literature search identified 365 articles in which the SOUNDBRIDGE was the target of primary research, published between 1997 and 2019 (6 articles were officially published in 2020, but pre-prints were available in late 2019). Articles in which the SOUNDBRIDGE was mentioned but not the primary target of interest were not considered. 219 articles reported on clinical outcomes in patients with hearing loss that had been treated with a SOUNDBRIDGE. 146 articles reported on methodological, technical or financial topics relating to the SOUNDBRIDGE or reviewed primary literature and were therefore not further analyzed. The number of articles reporting on target outcomes as well as the number of those included in meta-analyses is summarized in Figure 3.1. The proportion of articles qualifying for meta-analysis (i.e. sample size equal or larger than 3 patients AND standard deviation (SD) reported) was similar across outcomes (SF-PTA4: 37.7%, WRS65: 37.1%, SRT50N: 40.7%, APHAB: 47.1% and Daily use: 33.3%), indicating that in more than half of the publications, average outcomes were reported without a measure of variation around the mean.
All studies investigating the SOUNDBRIDGE were observational, either retrospective chart reviews (N=188) or prospective cohort studies (N=40). It should be noted that the type of intervention itself (i.e., implantation of aMEI) makes neither blinding nor randomizing applicable to studies investigating hearing implants. In the absence of randomized controlled trials, the highest level of evidence is generated by prospective cohort studies.
ᐅ Mouse-over columns to see
more details
Figure 3.2: Absolute (per year) and cumulative number of publications (N=365) investigating the SOUNDBRIDGE between January 1997 and December 2019. Please note that some publications that were available as preprints in 2019 were officially published in 2020.
3.2 Patient demographics
The 219 publications reporting clinical outcomes were based on studies conducted in 32 countries in Europe, North and South America, Asia and Australia. These studies included a total of 3616 patients (3053 in chart reviews and 563 in prospective cohort studies) with 3752 SOUNDBRIDGE placements (3187 in chart reviews and 565 in prospective cohort studies). In several publications outcomes were stratified by age groups, usually distinguishing older children and adolescents (5 to 17 years of age) from adults (18 years or older). Ten studies also included a total of 44 young children (below 5 years of age) in their pediatric cohorts, but only two publications31,32 reported separate summary statistics for young children cohorts. Given the low overall sample size in pediatric studies, outcomes from young children and older children and adolescents were pooled in this report. Type of hearing loss was another important demographic parameter and 127 publications reported summary statistics separately for patients with conductive, mixed, or sensorineural hearing loss. Figures 3.3 and 3.4 summarize the pooled number of patients across age groups and types of hearing loss across included publications. Five publications33–37 specifically addressed outcomes in 37 bilaterally implanted patients, but there were 72 bilaterally implanted patients included across all publications.
By age group
Figure 3.3: Number of patients across all included studies, by age group.
Of the 3616 patients for whom clinical outcomes have been reported, 2222 were adults and 196 were under 18 years of age. For 1198 patients results were either reported in mixed cohorts, including both adults and pediatric patients or no age was reported at all. 44 children aged below 5 years were included in 44 studies, but only two publications (Mandalà 2011,32 Leinung 2017)31 specifically reported outcomes in young children. Due to the low sample size, these were pooled with older children and adolescents.
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By type of hearing loss
Figure 3.4: Number of patients across all included studies, by type of hearing loss
Of the 3616 patients for whom clinical outcomes have been reported, 1693 had sensorineural hearing loss, 830 had mixed hearing loss, 305 patients had conductive hearing loss, and for 788 patients no specific type of hearing loss was reported (including patients that were pooled in ‘mixed-and-conductive HL’ groups.
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3.3 Audiological outcomes
3.3.1 Sound-field PTA4
Aided SF thresholds (PTA4) were reported in 89 patient cohorts (940 SOUNDBRIDGE placements in 63 publications). Out of these, 60 cohorts (589 SOUNDBRIDGE placements in 47 publications) were eligible for quantitative analysis. Mean aided SF PTA4 values varied considerably among studies, ranging from 17.95dB to 70dB. As shown in Figure 3.5, meta-analysis indicated a mean aided PTA4 of 34.6dB (95% CI: 32.4-36.8) and a mean functional gain of 33.9dB (95% CI: 30.5-37.3) when pooling all studies together. Forest plots showing results of single studies can be found in Appendix B1 and Appendix B2, respectively.
ᐅ Use buttons on top of each figure to zoom in/out or to export figures
ᐅ Click on legend symbols to hide/show single categories
Figure 3.5: Meta-analysis of combined aided and unaided PTA4 SF-thresholds.
Figure 3.6: Relative importance of predictors to SF-PTA4, based on multi-model inference. Confounders with values greater than 0.8 are usually considered significant.
To explore potential causes of variation in aided SF-PTA4 among publications, the following predictors were included into the meta-analytic model: Age group (Adults, Pediatrics), Type of hearing loss (CHL, MHL, SNHL), FMT coupling location (Incus, Stapes, Round window, Oval window) and F/U time. Age group had the biggest effect on aided PTA4 (Figure 3.6), indicating better average outcomes in the pediatric population compared to adults (see Figure 3.7 below for subgroup-specific values). Because the pediatric population almost exclusively included patients with pure conductive hearing loss (mostly atresia patients), the separate effects of age group and type of hearing loss cannot be disentangled statistically. From a technical point of view, the type of hearing loss is expected to be more important than age, but more data, especially in adult or non-atretic CHL patients, would be needed to investigate interaction effects more thoroughly. Independent of age, FMT coupling location and Testing time did not have a significant effect on the mean aided PTA4 outcome, indicating that aided SF thresholds (PTA4) were not significantly different among patients with different FMT coupling locations and did not change significantly over up to 11 years post-implantation (see subgroup analysis below).
Subgroup analysis was performed to quantify differences among subgroup levels and therefore, mixed levels (e.g. Unspecified) were excluded from meta-analyses to reduce masking effects. Average values (including confidence and prediction intervals) and average differences in aided PTA4 among subgroups can be explored in the tabbed section below (Figures 3.7 through 3.10). Please note that sample sizes may differ from the base model and among predictors.
By age group
Figure 3.7: Effect of age group on mean aided PTA4 thresholds. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
For 71 cohorts (810 placements in 52 studies) specific information on age group was available. Data from 44 cohorts (481 placements in 38 studies) qualified for inclusion in a subgroup meta-analysis (Adults: 32 cohorts, Pediatrics: 12 cohorts). On average, pediatric studies reported significantly lower (better) aided SF thresholds (-9.95dB, p<0.001) than studies on adult patients.
By type of HL
Figure 3.8: Effect of HL type on mean aided PTA4 thresholds. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
For 59 cohorts (551 placements in 47 studies) specific information on the type of hearing loss was available. Data from 46 cohorts (355 placements in 37 studies) qualified for inclusion in a subgroup meta-analysis (CHL: 16 cohorts, MHL: 11 cohorts and SNHL: 13 cohorts). Significantly lower (better) aided thresholds were reported for CHL patient cohorts compared to MHL (-9.76dB, p<0.01) cohorts, and SNHL (-8.71dB, p<0.01) cohorts, respectively.
By FMT coupling
Figure 3.9: Effect of coupling type on mean aided PTA4 thresholds. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
For 53 cohorts (517 placements in 38 studies) specific information on the FMT coupling location was available. Data from 32 cohorts (273 placements in 25 studies) qualified for inclusion in a subgroup meta-analysis (Incus: 14 cohorts, Stapes: 5 cohorts, RW: 8 cohorts and OW: 1 cohorts). Coupling type (i.e. the site of FMT attachment) did not have a significant overall effect on the mean aided SF thresholds (p=0.759) and there were no significant differences among specific subgroup levels.
By F/U time
Figure 3.10: Effect of F/U time on mean aided PTA4 thresholds. Mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles). The dashed line indicates values as predicted by the meta-analysis, thus not including open circles. The grey area indicates the corresponding 95% confidence interval.
For 89 cohorts (940 placements in 63 studies) specific information on the F/U time was available. Data from 60 patient cohorts (589 placements in 47 studies) qualified for inclusion in a meta-regression analysis. Only the last test interval was included if studies reported aided thresholds at Unspecified testing intervals. F/U time did not have a significant effect on the mean aided SF threshold (p=0.738).
3.3.2 WRS at 65dB SPL
Aided word recognition score measured at S0N0 and 65dB SPL (WRS65) was reported in 79 patient cohorts (945 SOUNDBRIDGE placements in 52 publications). Out of these, 52 cohorts (599 SOUNDBRIDGE placements in 36 publications) were eligible for quantitative analysis. Aided mean WRS65 values varied considerably among studies, ranging from 51% to 100%. Meta-analysis resulted in a pooled aided WRS65 of 79.6% with a narrow confidence interval (95% CI: 76.4-82.9) indicating a good estimate of the true mean (Figure 3.11). The forest plot showing results of single studies can be found in Appendix B3.
Figure 3.11: Meta-analysis of combined aided and unaided WRS at 65dB SPL.
Figure 3.12: Relative importance of predictors to WRS65, based on multi-model inference. Confounders with values greater than 0.8 are usually considered significant.
To explore potential causes of variation in aided WRS65 among publications, the following predictors were included into the meta-analytic model: Age group (Adults, Pediatrics), Type of hearing loss (CHL, MHL, SNHL), FMT coupling location (Incus, Stapes, Round window, Oval window), F/U time and Speech test (Monosyllabic, Bisyllabic). At least two parameters had a potential influence on aided WRS65 (Figure 3.12): Speech test and F/U time. Patients had higher WRS65 scores when bisyllabic word tests were used instead of monosyllabic tests, and even better results were achieved when using sentence tests (but only one publication was available in the last subgroup). This is not surprising given the step-wise increase in available auditory cues provided by monosyllables, bisyllables and sentences, respectively.
Aided WRS65 decreased slightly over F/U time, but this was not statistically significant when tested in a separate subgroup meta-analysis (Figure 3.17), indicating potential interaction effects with other predictors.
Subgroup analysis was performed to quantify differences among subgroup levels and therefore, mixed levels (e.g. Unspecified) were excluded from meta-analyses to reduce masking effects. Average values (including confidence and prediction intervals) and average differences in aided WRS65 among subgroups can be explored in the tabbed section below (Figures 3.13 through 3.17). Please note that sample sizes may differ from the base model and among predictors.
By age group
Figure 3.13: Effect of age group on mean aided word recognition score at 65dB SPL. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
For 61 cohorts (779 placements in 41 studies) specific information on age group was available. Data from 44 cohorts (521 placements in 29 studies) qualified for inclusion in a subgroup meta-analysis (Adults: 37 cohorts, Pediatrics: 7 cohorts). On average, pediatric studies reported significantly higher (better) aided WRS (+15.93%, p<0.001) than studies on adult patients.
By type of HL
Figure 3.14: Effect of HL type on mean aided word recognition score at 65dB SPL. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
For 51 cohorts (534 placements in 37 studies) specific information on type of hearing loss was available. Data from 32 cohorts (266 placements in 25 studies) qualified for inclusion in a subgroup meta-analysis (CHL: 6 cohorts, MHL: 15 cohorts, SNHL: 11 cohorts). Aided WRS65 scores reported for CHL patients were significantly higher (better) compared to MHL (+15.30%, p<0.05) cohorts and SNHL (+11.65%, p<0.05) cohorts, respectively.
By type of coupling
Figure 3.15: Effect of FMT coupling site on mean aided WRS at 65dB SPL. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
For 59 cohorts (739 placements in 40 studies) specific information on the FMT coupling location was available. Data from 39 cohorts (493 placements in 26 studies) qualified for inclusion in a subgroup meta-analysis (Incus: 11 cohorts, Stapes: 7 cohorts, RW: 17 cohorts and OW: 4 cohorts). Coupling type (i.e. the site of FMT attachment) did not have a significant overall effect on aided WRS65 (p=0.364).
By speech test
Figure 3.16: Effect of speech test material on mean aided WRS at 65dB SPL. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
The speech material used to measure WRS65 in quiet may consist of sentences or words (including numbers), and the latter can be mono- or bisyllabic. For 65 cohorts (831 placements in 43 studies) specific information on the type of speech test used was available. Data from 48 cohorts (579 placements in 33 studies) qualified for inclusion in a subgroup meta-analysis (Monosyllabic: 37 cohorts, Bisyllables: 11 cohorts). The ‘sentence’ subgroup was removed from the model because only 1 study was eligible for quantitative analysis in this subgroup. There was no statistical difference in the estimated means among studies using monosyllables vs. bisyllables (p= 0.15). However, studies using bisyllables reported on average higher WRS65 (+5.24%) compared to monosyllables.
By F/U time
Figure 3.17: Effect of F/U time on mean aided WRS at 65dB SPL. Mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles). The dashed line indicates values as predicted by the meta-analysis, thus not including open circles. The grey area indicates the corresponding 95% confidence interval.
For 79 cohorts (945 placements in 52 studies) specific information on the F/U time was available. Data from 52 cohorts (599 placements in 36 studies) qualified for inclusion in a meta-regression analysis. Only the last test interval was included if studies reported aided thresholds at Unspecified testing intervals. F/U time did not have a significant effect on mean aided WRS65 (p= 0.14).
3.3.3 SRT in noise (SRT50N)
Speech recognition threshold in noise (SRT50N) was reported for 48 patient cohorts (529 SOUNDBRIDGE placements in 27 publications). Out of these, 18 cohorts (194 SOUNDBRIDGE placements in 11 publications) were eligible for quantitative analysis. Mean aided values varied among studies to such a degree (8.5dB SNR to -11dB SNR) that comparison among studies was questionable. Meta-analysis was therefore run on improvement scores, indicating a pooled mean improvement of 5.1dB SNR from the respective unaided value (95% CI: 3.9-6.2)(Figure 3.18). A forest plot showing results of single studies can be found in Appendix B4.
ᐅ SRT in noise is analyzed in terms of improvement rather than absolute unaided/aided scores, as indicated by a different colour scheme.
Figure 3.18: Meta-analysis of combined SRT50 improvement in noise.
Figure 3.19: Relative importance of potential predictors to SRT50 in noise, based on multi-model inference. Confounders with values greater than 0.8 are usually considered significant.
To explore potential causes of variation in SRT50N improvement among publications, the following predictors were included into the meta-analytic model: Age group (Adults, Pediatrics), Type of hearing loss (CHL, MHL, SNHL), FMT coupling location (Incus, Stapes, Round window, Oval window), Speech test setup (S0N0, S0N180, S180N0, S0N90, S0N270) and F/U time. Analysis of potential predictors showed that none of the confounders had a significant effect on SRT50N improvement (Figure 3.19). Given the low sample size, however, these results must be interpreted with care until confirmed on a more complete dataset. SRT50N improvement scores showed similar variation across subgroups in all confounders, leaving space for alternative, un-reported sources of variation. Given the technical complexity of speech in noise measurements, methodological parameters or clinic-specific settings that are usually not reported in medical publications may have contributed to the variability observed in this dataset.
Subgroup analysis was performed to quantify differences among subgroup levels; mixed levels (e.g. Unspecified) were therefore excluded from meta-analyses to reduce masking effects. Average values (including confidence and prediction intervals) and average differences among subgroups can be explored in the tabbed section below (Figures 3.20 through 3.24). Please note that sample sizes may differ from the base model and among predictors.
By age group
Figure 3.20: Effect of age group on improvement in SRT50N. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean improvement values of single studies are plotted (circles), including those not included in meta-analyses due to missing standard deviation.
For 47 cohorts (522 placements in 27 studies) specific information on age group was available. Data from 17 cohorts (187 placements in 11 studies) qualified for inclusion in a subgroup meta-analysis (Adults: 13 cohorts, Pediatrics: 4 cohorts). Age group did not have a significant effect on SRT50N improvement (p= 0.68).
By type of HL
Figure 3.21: Effect of hearing loss type on improvement in SRT50N. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean improvement values of single studies are plotted (circles), including those not included in meta-analyses due to missing standard deviation.
For 26 cohorts (187 placements in 16 studies) specific information on type of hearing loss was available. Data from 7 cohorts (53 placements in 5 studies) qualified for inclusion in a subgroup meta-analysis (CHL: 0 cohorts, MHL: 3 cohorts, SNHL: 4 cohorts). Type of hearing loss did not have a significant effect on SRT50N improvement (p= 0.76).
By FMT coupling
Figure 3.22: Effect of FMT coupling type on improvement in SRT50N. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean improvement values of single studies are plotted (circles), including those not included in meta-analyses due to missing standard deviation.
For 11 cohorts (61 placements in 8 studies) specific information on the FMT coupling location was available. Data from 7 cohorts (39 placements in 4 studies) qualified for inclusion in a subgroup meta-analysis (Incus: 6 cohorts, Stapes: 0 cohorts, RW: 1 cohorts and OW: 0 cohorts). No subgroup meta-analysis was run in the RW subgroup due to N=1, but this publication was still included in the combined analysis. Because of only one subgroup level (Incus) being left, the effect of different coupling locations on SRT50N improvement could not be analyzed.
By Test setup
Figure 3.23: Effect of test setup on improvement in SRT50N. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean improvement values of single studies are plotted (circles), including those not included in meta-analyses due to missing standard deviation.
For 23 cohorts (249 placements in 16 studies) specific information on the Test setup was available. Data from 12 cohorts (140 placements in 7 studies) qualified for inclusion in a subgroup meta-analysis (S0N0: 8 cohorts, S0N180: 2 cohorts and S180N0: 2 cohorts). Test setup did not have a significant effect on SRT50N improvement (p= 0.86), but sample sizes were low in S0N180 and S180N0 subgroups.
By F/U time
Figure 3.24: Effect of F/U time on mean improvement in SRT50N. Mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles). The dashed line indicates values as predicted by the meta-analysis, thus not including open circles. The grey area indicates the corresponding 95% confidence interval.
For 33 cohorts (300 placements in 20 studies) specific information on the F/U time was available. Data from 13 cohorts (131 placements in 9 studies) qualified for inclusion in a meta-regression analysis. Only the last test interval was included if studies reported SRT50N improvement at Unspecified testing intervals. F/U time did not have a significant effect on SRT50N improvement (p= 0.07).
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3.4 Patient-reported outcomes
Outcome measures that are collected from patients directly via questionnaires (i.e. Patient-Reported Outcome Measures, PROMs) have been increasingly reported in the medical literature in recent years. Publications included in this literature review have used the following questionnaires as a direct measure of patient satisfaction or quality of life (QoL) after implantation of a SOUNDBRIDGE: APHAB, GBI, GCBI, GHABP, HDSS, HISQUI29, IOI-HA, NCIQ, PHAP, SHACQ, and SSQ. Out of these, only the Abbreviated Profile of Hearing Aid Benefit (APHAB) has been used in a significant number of publications. This is not surprising since the APHAB is in some countries routinely used to monitor the success of hearing aids in general. Daily use (in hours per day) is another parameter that is increasingly reported in the literature on hearing implants, either as a standalone question or within custom-designed questionnaires.
3.4.1 APHAB questionnaire
The Abbreviated Profile of Hearing Aid Benefit (APHAB)38,39 is a 24-item questionnaire used to measure the impact of hearing problems on a person’s daily life. Specifically, it quantifies the disability associated with hearing loss (Frequency of problems in %) and - if administered after treatment - the reduction of disability that is achieved with a hearing aid. Six items are scored to deliver each one of four subscales (BN, RV, EC, AV). Subscales BN, RV and EC can be averaged to generate a global score (GS). The subscales are described as follows:
Background Noise (BN): Communication in settings with high background noise levels. Scores for BN will be most closely related to measures of high-frequency sensitivity and to objective clinical tests of speech understanding in noise.
Reverberation (RV): Communication in reverberant rooms such as classrooms. Scores for RV will be most closely related to objective measures of speech understanding in noise and to high-frequency sensitivity. Although the RV items concern communication when speech is masked by reverberation (reflections and temporal smearing) rather than ambient noise, several studies have suggested that the effects of reverberation masking are generally similar to those of noise masking.
Ease of Communication (EC): The strain of communicating under relatively favourable conditions. The EC score will be most closely related to measures describing midfrequency sensitivity and / or objective clinical tests of speech understanding in quiet conditions.
Aversiveness (AV): The negative reactions to or unpleasantness of environmental sounds.
ᐅ The APHAB questionnaire was designed to quantify problems in daily hearing situations. Therefore, lower scores indicate less problems, i.e. better outcomes.
Figure 3.25: Meta-analysis of combined aided and unaided APHAB global scores.
APHAB scores have been reported for 25 cohorts (298 placements in 17 publications) and among these, 11 cohorts (141 placements in 8 publications) were eligible for quantitative analysis. Meta-analysis estimated a pooled aided global score of 30.8% (95% CI: 23.2-38.5)(Figure 3.25). A forest plot showing results of single studies can be found in the Appendix B5. A global score around 31% indicates that the SOUNDBRIDGE can lower the amount of hearing-loss related problems to the same degree as traditional hearing aids in an elderly population.39
Subscales scores can be explored in the tabbed section below, either in comparison to unaided scores (Figure 3.26) or the patient’s previously-worn hearing aid (Figure 3.27). It should be noted that outcomes with previously-worn hearing aids are expected to be suboptimal (otherwise there is no need for a middle ear implant) and should not be mistaken for outcomes after successful hearing aid treatment, e.g. such as those reported by Johnson et al. 201039 or Löhler et al. 2017.40
No subgroup analysis was performed for APHAB scores since all but one publication reported on adult patients with sensorineural hearing loss and incus coupling. Instead, results are split by APHAB subscores, comparing aided vs. unaided and aided vs. hearing aid (Figures 3.26 through 3.27).
APHAB subscores Aided vs. Unaided
Figure 3.26: APHAB subscores in aided (SOUNDBRIDGE) and unaided condition: GS = Global score, BN = Background noise, RV = Reverberation, EC = Ease of communication, AV = Aversiveness to sound
Out of 11 cohorts eligible for meta-analysis, only 2 reported unaided global scores and 3 reported unaided subscores. These are, however, in line with unaided scores reported in publications excluded from meta-analysis (open circles). On average, patients reported 28.9% less problems with Background noise, 33.0% less problems with Reverberation and 22.5% less problems with Ease of communication compared to the unaided situation. Scores on the Aversiveness scale changed by 4.9% on average, indicating that unpleasant sounds were not perceived as more disturbing when heard through the SOUNDBRIDGE.
APHAB subscores Aided vs. Hearing aid
Figure 3.27: APHAB subscores compared to previously worn hearing aids: GS = Global score, BN = Background noise, RV = Reverberation, EC = Ease of communication, AV = Aversiveness to sound
Out of 17 publications reporting APHAB scores after SOUNDBRIDGE treatment, 6 publications reported aided scores with previously worn hearing aids as well. When compared to hearing aids, patients reported on average 23.4% less problems with Background noise, 19.8% less problems with Reverberation and 25.3% less problems with Ease of communication. Scores on the Aversiveness scale changed by 10.1% on average, indicating that unpleasant sounds were perceived less disturbing when heard through the SOUNDBRIDGE as compared to previously worn hearing aids.
3.4.2 Daily use
ᐅ The gray area indicates the timeframe between typical working hours (8 hours) and typical waking hours (16 hours) in the general population.
Figure 3.28: Meta-analysis of daily use of the SOUNDBRIDGE.
The amount of time that patients choose to use their hearing device is a potential indicator for patient satisfaction.41,42 Different methods exist to measure device usage, ranging from interviews and questionnaires to automated datalogging. The wide range of available options has hindered pooled analyses across studies in the hearing aid literature43 and a consensus on standardized reporting is still lacking to date. Datalogging is only starting to become visible in the hearing-implant literature, and most publications so far collected daily use data via traditional questionnaires.
Publications reporting outcomes with aMEIs rarely included data on daily use, but if so they reported mean usage time in hours per day, with or without standard deviation. Specifically, 7 cohorts (93 placements in 7 publications) reported mean daily use, 5 of which were eligible for meta-analysis.
Due to the small sample size, no predictors were included in meta-analyses and no subgroup analyses were conducted exept for age group. Overall, mean daily use was estimated at 11.9 hours per day. A larger variation was observed in adults, where reported means ranged between 8.0 and 18.4 hours per day, compared to the pediatric population, where means varied between 9.0 and 10.0 hours per day (Figure 3.29).
By age group
Figure 3.29: Daily use [hrs/day] reported via patient questionnaires. The gray area indicates the timeframe between typical working hours (8 hours) and typical waking hours (16 hours) in the general population. Box plots indicate outcomes of separate meta-analyses, i.e. overall estimated mean (black bar), confidence interval (boxes) and prediction interval (whiskers). Alongside each box plot mean values are plotted for single cohorts included in meta-analyses (filled circles) and not included due to missing standard deviation (open circles).
4 Conclusion
Data from over two hundred publications reporting on the clinical effectiveness of the SOUNDBRIDGE were available up to December 2019. Taken together, this body of literature provides compelling evidence for successful hearing rehabilitation with the SOUNDBRIDGE active middle ear implant. Specifically, aided hearing thresholds, speech in quiet and speech in noise tests all indicate good hearing rehabilitation in different listening situations in both indication groups. Moreover, hearing-related quality of life and daily usage data show that patients perceived a clear benefit and used the device throughout the day. With follow-up times of up to 11 years available, the reviewed literature also indicates that benefits provided by the SOUNDBRIDGE remained stable over many years.
Analyses of demographic and clinical predictors indicated a positive effect of age group and type of hearing loss across audiological outcomes, with pediatric and pure conductive hearing loss patients performing better than adults and sensorineural (or mixed) hearing loss patients, respectively. The use of different coupling locations for the floating mass transducer did not have a significant effect in any of the outcomes, thus giving surgeons full flexibility in choosing the optimal coupling on a case-by-case basis, without any loss of benefit.
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Abbreviations
| - | not reported |
| AC | Air Conduction |
| ad | adults |
| AICc | corrected Akaike Information Criterion |
| aMEI | active Middle Ear Implant |
| APHAB | Abbreviated Profile of Hearing Aid Benefit questionnaire |
| AV | Aversiveness to sound |
| BC | Bone Conduction |
| BN | Background Noise |
| CE | Conformité Européenne |
| CHL | Conductive Heaering Loss |
| CI | Confidence Interval |
| CPL | Coupling type |
| dB HL | decibel Hearing Level |
| dB SNR | decibel Signal-to-Noise Ratio |
| dB SPL | decibel Sound-Pressure Level |
| EC | Ease of Communication |
| EFTA | European Free Trade Association |
| EU | European Union |
| F/U | Follow-Up |
| FMT | Floating Mass Transducer |
| GBI | Glasgow Benefit Inventory |
| GCBI | Glasgow Children Benefit Inventory |
| GHABP | Glasgow Hearing Aid Benefit Profile |
| HDSS | Hearing Device Satisfaction Scale |
| HISQUI29 | Hearing Implant Sound Quality Index |
| HL | Hearing Loss |
| hrs | hours |
| IDE | Integrated Development Environment |
| IN | Incus |
| IOI-HA | International Outcome Inventory for Hearing Aids |
| MHL | Mixed Hearing Loss |
| N | sample size |
| OW | Oval Window |
| ped | pediatrics |
| PHAP | Profile of Hearing Aid Performance |
| PROMs | Patient-Reported Outcome Measures |
| PTA4 | Pure-Tone Average over 4 frequencies (0.5, 1, 2 and 4 kHz) |
| RE | Random Effects (meta-analysis) |
| RMLE | Restricted Maximum Likelihood Estimator |
| RV | Reverberation |
| RW | Round Window |
| S0N0 | both Sound and Noise from front |
| S0N180 | Sound from front, Noise from behind |
| S0N270 | Sound from front, Noise from contralateral side |
| S0N90 | Sound from front, Noise from implanted side |
| S180N0 | Sound from behind, Noise from front |
| SD | Standard Deviation |
| SF | Sound-Field |
| SHACQ | Success and Happiness Attributes Questionnaire |
| SNHL | Sensorineural Hearing Loss |
| SRT50N | Speech Reception Threshold in Noise |
| SSQ | Speech, Spatial and Qualities of Hearing Scale |
| ST | Stapes |
| URL | Uniform Resource Locator |
| WRS65 | Word Recognition Score measured at 65dB |
References
Appendix
A Methods
A.1 Search terms
Search terms targeting SOUNDBRIDGE in Single-Sided-Deafness (SSD):
ssd OR “single-sided deafness” OR “unilateral deafness” OR “unilateral profound hearing loss” OR “bone anchored hearing aid” OR baha OR “bone conduction hearing aid” OR bahd OR ponto OR sophono OR soundbite OR “asymmetric hearing loss” NOT pons
Search terms targeting SOUNDBRIDGE directly:
“vibrant soundbridge” OR soundbridge OR “floating mass transducer” OR “middle ear implant” OR amei OR Vibroplasty OR “implantable hearing aid” OR “active middle ear implants” OR “implantable hearing device”
Search terms targeting active Middle Ear Implants (aMEIs) in general:
“vibrant soundbridge” OR soundbridge OR “floating mass transducer” OR “middle ear implant” OR amei OR Vibroplasty OR VSB OR “implantable hearing aid” OR “active middle ear implants” OR “implantable hearing device” OR “active middle ear implant” OR “otologics MET” OR Otologics OR DACS OR DACI OR “Envoy Esteem” OR Carina OR MET OR Maxum OR Earlens NOT “self-esteem” NOT “diacetylchitobiose deacetylases” NOT deacetylases NOT “-DACI” NOT diamidocarbenes AND Hearing
Go back to Methods: Search terms
A.2 Publications included
| ID | Reference |
|---|---|
| 1 | Tjellstrom, A., et al., Acute human trial of the floating mass transducer. Ear Nose Throat J, 1997. 76(4): p. 204-6, 209-10. |
| 2 | Ball, G.R., A. Huber, and R.L. Goode, Scanning laser Doppler vibrometry of the middle ear ossicles. Ear Nose Throat J, 1997. 76(4): p. 213-8, 220, 222. |
| 3 | Gan, R.Z., et al., Implantable hearing device performance measured by laser Doppler interferometry. Ear Nose Throat J, 1997. 76(5): p. 297-9, 302, 305-9. |
| 4 | Snik, A.F., E.A. Mylanus, and C.W. Cremers, Implantable hearing devices for sensorineural hearing loss: a review of the audiometric data. Clin Otolaryngol Allied Sci, 1998. 23(5): p. 414-9. |
| 5 | Lenarz, T., et al., [The Vibrant Soundbridge System: a new kind of hearing aid for sensorineural hearing loss. 1: Function and initial clinical experiences]. Laryngorhinootologie, 1998. 77(5): p. 247-55. |
| 6 | Hüttenbrink, K.B., Current status and critical reflections on implantable hearing aids. Am J Otol, 1999. 20(4): p. 409-15. |
| 7 | Bouccara, D., Nouvelle modalité de réhabilitation de l’audition : prothèse Vibrant Soundbridge Symphonix. La Lettre d’Oto-Rhino-Laryngologie 1999. 241: p. 29-30. |
| 8 | Richards, A. and M. Gleeson, Recent advances: otolaryngology. Bmj, 1999. 319(7217): p. 1110-3. |
| 9 | Snik, A.F. and C.W. Cremers, First audiometric results with the Vibrant soundbridge, a semi-implantable hearing device for sensorineural hearing loss. Audiology, 1999. 38(6): p. 335-8. |
| 10 | Cremers, C. and A. Snik, De Vibrant Soundbridge, een semi-implanteerbaar hoortoestel voor perceptieve lechthorendheid. Ned Tijdschr KNO-Heelkunde, 1999. 5: p. 158-161. |
| 11 | Snik, F.M. and W.R. Cremers, The effect of the floating mass transducer in the middle ear on hearing sensitivity. Am J Otol, 2000. 21(1): p. 42-8. |
| 12 | Dazert, S., J.P. Thomas, and S. Volkenstein, Surgical and Technical Modalities for Hearing Restoration in Ear Malformations. Facial Plast Surg, 2015. 31(6): p. 581-6. |
| 13 | Babighian, G. and M. Mazolli, Prothèse implantable d’oreille moyenne. Résultats cliniques. Les Cahiers D’O R L, 2000. 15(8): p. 322-330. |
| 14 | Ernst, A., Implantierbare Hörsysteme. HNO, 2001. 9(1): p. 13-15. |
| 15 | Dieler, R., Dazert, S., Shehata-Dieler,W. and Helms, J., Evaluierung der funktionellen Ergebnisse mit dem aktiven Mittelohrimplantat Vibrant Soundbridge. HNO, 2001. 25(2): p. 75. |
| 16 | Snik, A.F., et al., Multicenter audiometric results with the Vibrant Soundbridge, a semi-implantable hearing device for sensorineural hearing impairment. Otolaryngol Clin North Am, 2001. 34(2): p. 373-88. |
| 17 | Ashburn-Reed, S., The first FDA-approved middle ear implant: The Vibrant Soundbridge. The Hearing Journal, 2001. 54(8): p. 47-48. |
| 18 | Lenarz, T., et al., [Vibrant Sound Bridge System. A new kind hearing prosthesis for patients with sensorineural hearing loss. 2. Audiological results]. Laryngorhinootologie, 2001. 80(7): p. 370-80. |
| 19 | Fisch, U., et al., Clinical experience with the Vibrant Soundbridge implant device. Otol Neurotol, 2001. 22(6): p. 962-72. |
| 20 | Fraysse, B., et al., A multicenter study of the Vibrant Soundbridge middle ear implant: early clinical results and experience. Otol Neurotol, 2001. 22(6): p. 952-61. |
| 21 | Snik, A.F. and C.W. Cremers, Vibrant semi-implantable hearing device with digital sound processing: effective gain and speech perception. Arch Otolaryngol Head Neck Surg, 2001. 127(12): p. 1433-7. |
| 22 | Chasin, M. and J. Spindle, Middle ear implants: A new technology. The Hearing Journal, 2001. 54(8): p. 33. |
| 23 | Dubreuil, C., Indication limits for middle ear vibrating Symphonix Soundbridge implant and cochlear implant. One case study. JFORL J Fr Otorhinolaryngol Audiophonol Chir Maxillofac, 2002. 51(4): p. 159-161. |
| 24 | Luetje, C.M., et al., Phase III clinical trial results with the Vibrant Soundbridge implantable middle ear hearing device: a prospective controlled multicenter study. Otolaryngol Head Neck Surg, 2002. 126(2): p. 97-107. |
| 25 | Junker, R., et al., Functional gain of already implanted hearing devices in patients with sensorineural hearing loss of varied origin and extent: Berlin experience. Otol Neurotol, 2002. 23(4): p. 452-6. |
| 26 | Todt, I., et al., Comparison of different vibrant soundbridge audioprocessors with conventional hearing AIDS. Otol Neurotol, 2002. 23(5): p. 669-73. |
| 27 | Winter, M., B.P. Weber, and T. Lenarz, Measurement method for the assessment of transmission properties of implantable hearing aids. Biomed Tech (Berl), 2002. 47 Suppl 1 Pt 2: p. 726-7. |
| 28 | Thill, M.P., et al., Belgian experience with the Vibrant Soundbridge prosthesis. Acta Otorhinolaryngol Belg, 2002. 56(4): p. 375-8. |
| 29 | Garin, P., et al., Speech discrimination in background noise with the Vibrant Soundbridge middle ear implant. Otorhinolaryngol Nova, 2002. 3(12): p. 119-123. |
| 30 | Sterkers, O., et al., A middle ear implant, the Symphonix Vibrant Soundbridge: retrospective study of the first 125 patients implanted in France. Otol Neurotol, 2003. 24(3): p. 427-36. |
| 31 | Uziel, A., et al., Rehabilitation for high-frequency sensorineural hearing impairment in adults with the symphonix vibrant soundbridge: a comparative study. Otol Neurotol, 2003. 24(5): p. 775-83. |
| 32 | Snik, A. and C. Cremers, Audiometric evaluation of an attempt to optimize the fixation of the transducer of a middle-ear implant to the ossicular chain with bone cement. Clin Otolaryngol Allied Sci, 2004. 29(1): p. 5-9. |
| 33 | Snik, A., J. Noten, and C. Cremers, Gain and maximum output of two electromagnetic middle ear implants: are real ear measurements helpful? J Am Acad Audiol, 2004. 15(3): p. 249-57. |
| 34 | Langevin, S., Surdité neurosensorielle: Les implants d’oreille moyenne. Cahier Biomédical, 2004. 165: p. 25-30. |
| 35 | Vincent, C., et al., A longitudinal study on postoperative hearing thresholds with the Vibrant Soundbridge device. Eur Arch Otorhinolaryngol, 2004. 261(9): p. 493-6. |
| 36 | Todt, I., et al., MRI scanning and incus fixation in vibrant soundbridge implantation. Otol Neurotol, 2004. 25(6): p. 969-72. |
| 37 | Jiang, D., A. Bibas, and A.F. O’Connor, Minimally invasive approach and fixation of cochlear and middle ear implants. Clin Otolaryngol Allied Sci, 2004. 29(6): p. 618-20. |
| 38 | a Wengen, D.F., [Implantable middle ear hearing aids]. Ther Umsch, 2004. 61(1): p. 47-52. |
| 39 | Needham, A.J., et al., The effects of mass loading the ossicles with a floating mass transducer on middle ear transfer function. Otol Neurotol, 2005. 26(2): p. 218-24. |
| 40 | Saliba, I., et al., Binaurality in middle ear implant recipients using contralateral digital hearing AIDS. Otol Neurotol, 2005. 26(4): p. 680-5. |
| 41 | Todt, I., R.O. Seidl, and A. Ernst, Hearing benefit of patients after Vibrant Soundbridge implantation. ORL J Otorhinolaryngol Relat Spec, 2005. 67(4): p. 203-6. |
| 42 | Garin, P., M. Debaty, and C. Galle, Hearing in noise with the vibrant Soundbridge middle-ear implant. Cochlear Implants Int, 2005. 6 Suppl 1: p. 72-4. |
| 43 | Labassi, S. and M. Beliaeff, Retrospective of 1000 patients implanted with a vibrant Soundbridge middle-ear implant. Cochlear Implants Int, 2005. 6 Suppl 1: p. 74-7. |
| 44 | Babighian, G. and M. Mazzoli, Implantable middle-ear implants: our experience. Cochlear Implants Int, 2005. 6 Suppl 1: p. 65-9. |
| 45 | Foyt, D. and M. Carfrae, Minimal access surgery for the Symphonix/Med-El Vibrant Soundbridge middle ear hearing implant. Otol Neurotol, 2006. 27(2): p. 167-71. |
| 46 | Schmuziger, N., et al., Long-term assessment after implantation of the Vibrant Soundbridge device. Otol Neurotol, 2006. 27(2): p. 183-8. |
| 47 | Truy, E., et al., Vibrant soundbridge surgery: evaluation of transcanal surgical approaches. Otol Neurotol, 2006. 27(6): p. 887-95. |
| 48 | Colletti, V., et al., Treatment of mixed hearing losses via implantation of a vibratory transducer on the round window. Int J Audiol, 2006. 45(10): p. 600-8. |
| 49 | Kiefer, J., W. Arnold, and R. Staudenmaier, Round window stimulation with an implantable hearing aid (Soundbridge) combined with autogenous reconstruction of the auricle - a new approach. ORL J Otorhinolaryngol Relat Spec, 2006. 68(6): p. 378-85. |
| 50 | Snik, A.F., et al., Estimated cost-effectiveness of active middle-ear implantation in hearing-impaired patients with severe external otitis. Arch Otolaryngol Head Neck Surg, 2006. 132(11): p. 1210-5. |
| 51 | Huber, A.M., et al., A new implantable middle ear hearing device for mixed hearing loss: A feasibility study in human temporal bones. Otol Neurotol, 2006. 27(8): p. 1104-9. |
| 52 | Stieger, C., et al., Human temporal bones versus mechanical model to evaluate three middle ear transducers. J Rehabil Res Dev, 2007. 44(3): p. 407-15. |
| 53 | Dumon, T., Vibrant soundbridge middle ear implant in otosclerosis: technique - indication. Adv Otorhinolaryngol, 2007. 65: p. 320-2. |
| 54 | Venail, F., et al., New perspectives for middle ear implants: first results in otosclerosis with mixed hearing loss. Laryngoscope, 2007. 117(3): p. 552-5. |
| 55 | Offergeld, C., et al., Rotational tomography of the normal and reconstructed middle ear in temporal bones: an experimental study. Eur Arch Otorhinolaryngol, 2007. 264(4): p. 345-51. |
| 56 | Wollenberg, B., et al., [Integration of the active middle ear implant Vibrant Soundbridge in total auricular reconstruction]. HNO, 2007. 55(5): p. 349-56. |
| 57 | Snik, A.F., et al., Evaluation of the subjective effect of middle ear implantation in hearing-impaired patients with severe external otitis. J Am Acad Audiol, 2007. 18(6): p. 496-503. |
| 58 | Foyt, D., E. Steiniger, and S. Rende, Bone island tunnel for cochlear and vibrant soundbridge implantation. Laryngoscope, 2007. 117(8): p. 1395-6. |
| 59 | Böheim, K., A. Nahler, and M. Schlögel, [Rehabilitation of high frequency hearing loss: use of an active middle ear implant]. HNO, 2007. 55(9): p. 690-5. |
| 60 | Batman, C., et al., First use of the Vibrant Soundbridge middle ear implant in Turkish patients: A Report of 2 cases. Mediterr J Otol, 2007. 3: p. 167-172. |
| 61 | Arauz, S.L., et al., Vibrant Soundbridge-Ubicación en Ventana oval utilizando prótesis ad-hoc. Otolaringológica, 2007. XXIX: p. 10-14. |
| 62 | Cerini, R., et al., Bionic ear imaging. Radiol Med, 2008. 113(2): p. 265-77. |
| 63 | Mosnier, I., et al., Benefit of the Vibrant Soundbridge device in patients implanted for 5 to 8 years. Ear Hear, 2008. 29(2): p. 281-4. |
| 64 | Truy, E., et al., Vibrant soundbridge versus conventional hearing aid in sensorineural high-frequency hearing loss: a prospective study. Otol Neurotol, 2008. 29(5): p. 684-7. |
| 65 | Verhaegen, V.J., et al., Audiological application criteria for implantable hearing aid devices: a clinical experience at the Nijmegen ORL clinic. Laryngoscope, 2008. 118(9): p. 1645-9. |
| 66 | Skarzynski, H., et al., [Application of the middle ear implant in case of high frequency hearing loss–case study]. Otolaryngol Pol, 2008. 62(5): p. 606-12. |
| 67 | Hüttenbrink, K.B., et al., TORP-vibroplasty: a new alternative for the chronically disabled middle ear. Otol Neurotol, 2008. 29(7): p. 965-71. |
| 68 | Osaki, Y., et al., [Implantation of a vibratory mass transducer on the round window: a report of two cases]. Nihon Jibiinkoka Gakkai Kaiho, 2008. 111(10): p. 668-71. |
| 69 | Olgun, L., et al., Round Window Application of Implantable Hearing Aids in Radical Cavities. The mediterranean Journal of Otology, 2008. 2008(3): p. 191-196. |
| 70 | Manrique Rodriguez, M., L. Giron, and A. Huarte Irujo, [Active middle-ear implants]. Acta Otorrinolaringol Esp, 2008. 59 Suppl 1: p. 10-3. |
| 71 | Ramos Macias, A., [Surgical implantation of the Med-El vibrant Soundbridge]. Acta Otorrinolaringol Esp, 2008. 59 Suppl 1: p. 17-20. |
| 72 | Cenjor Espanol, C., C. Morera Perez, and A. Ramos Macias, [How middle-ear implants work]. Acta Otorrinolaringol Esp, 2008. 59 Suppl 1: p. 7-9. |
| 73 | Algaba Guimera, J., et al., [Results of middle-ear implants]. Acta Otorrinolaringol Esp, 2008. 59 Suppl 1: p. 30-2. |
| 74 | Cremers, C.W., V.J. Verhaegen, and A.F. Snik, The floating mass transducer of the Vibrant Soundbridge interposed between the stapes and tympanic membrane after incus necrosis. Otol Neurotol, 2009. 30(1): p. 76-8. |
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Go back to Methods: Systematic Review
B Forest plots
B.1 Sound-Field PTA4
Figure B.1: Forest plot of mean unaided and aided sound-field thresholds. Each row on the y-axis represents one cohort. For each cohort, mean aided and unaided thresholds (black and grey dots) and respective confidence intervals (red and hollow bars) are plotted on the x-axis. Straight lines indicate the mean benefit in each cohort. The red diamond in the bottom line represents the pooled estimate of the meta-analysis (center of the diamond) and its confidence interval (width of the diamond). The dashed line indicates the prediction interval. Studies are ordered by age group, hearing loss type and coupling type. N = sample size; ad = adults; ped = pediatrics; HL = hearing loss; MHL = mixed hearing loss; SNHL = sensorineural hearing loss; CHL = conductive hearing loss; CPL = coupling type; RW = round window; IN = incus; ST = stapes; OW = oval window; CI = confidence interval; dB HL = decibel hearing level; RE = random effects; ‘-’ = not reported.
Go back to Results: SF Thresholds
B.2 Functional gain
Figure B.2: Forest plot of functional gain. Each row on the y-axis represents one cohort. For each cohort, the mean benefit (i.e. functional gain) and its confidence interval (red bars) are plotted on the x-axis. The red diamond in the bottom line represents the pooled estimate of the meta-analysis (center of the diamond) and its confidence interval (width of the diamond). The dashed line indicates the prediction interval. Studies are ordered by age group, hearing loss type and coupling type. N = sample size; ad = adults; ped = pediatrics; HL = hearing loss; MHL = mixed hearing loss; SNHL = sensorineural hearing loss; CHL = conductive hearing loss; CPL = coupling type; RW = round window; IN = incus; ST = stapes; OW = oval window; CI = confidence interval; dB HL = decibel hearing level; RE = random effects; ‘-’ = not reported.
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B.3 WRS at 65dB
Figure B.3: Forest plot of mean unaided and aided word recognition score (WRS65) in quiet. Each row on the y-axis represents one cohort. For each cohort, mean aided and unaided thresholds (black and grey dots) and respective confidence intervals (red and hollow bars) are plotted on the x-axis. Straight lines indicate the mean benefit in each cohort. The red diamond in the bottom line represents the pooled estimate of the meta-analysis (center of the diamond) and its confidence interval (width of the diamond). The dashed line indicates the prediction interval. Studies are ordered by age group, hearing loss type and coupling type. N = sample size; ad = adults; ped = pediatrics; HL = hearing loss; MHL = mixed hearing loss; SNHL = sensorineural hearing loss; CHL = conductive hearing loss; CPL = coupling type; RW = round window; IN = incus; ST = stapes; OW = oval window; CI = confidence interval; dB HL = decibel hearing level; RE = random effects; MS = monosyllables; BS = bisyllables; ST = sentences; ‘-’ = not reported.
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B.4 SRT50 in noise
Figure B.4: Forest plot of mean improvement in SRT50 in noise. Each row on the y-axis represents one cohort. For each cohort, the mean benefit and its confidence interval (turquoise bars) are plotted on the x-axis. The turquoise diamond in the bottom line represents the pooled estimate of the meta-analysis (center of the diamond) and its confidence interval (width of the diamond). The dashed line indicates the prediction interval. Studies are ordered by age group, hearing loss type and coupling type. N = sample size; ad = adults; ped = pediatrics; HL = hearing loss; MHL = mixed hearing loss; SNHL = sensorineural hearing loss; CHL = conductive hearing loss; CPL = coupling type; RW = round window; IN = incus; ST = stapes; OW = oval window; CI = confidence interval; dB HL = decibel hearing level; RE = random effects; ‘-’ = not reported.
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B.5 APHAB Global Score
Figure B.5: Forest plot of mean APHAB global score (GS). Each row on the y-axis represents one cohort. For each cohort, mean aided and unaided thresholds (black and grey dots) and respective confidence intervals (red and hollow bars) are plotted on the x-axis. Straight lines indicate the mean benefit in each cohort. The red diamond in the bottom line represents the pooled estimate of the meta-analysis (center of the diamond) and its confidence interval (width of the diamond). The dashed line indicates the prediction interval. Studies are ordered by age group, hearing loss type and coupling type. N = sample size; ad = adults; ped = pediatrics; HL = hearing loss; MHL = mixed hearing loss; SNHL = sensorineural hearing loss; CHL = conductive hearing loss; CPL = coupling type; RW = round window; IN = incus; ST = stapes; OW = oval window; CI = confidence interval; dB HL = decibel hearing level; RE = random effects; MS = monosyllables; BS = bisyllables; ST = sentences; ‘-’ = not reported.
Go back to Results: APHAB Global Score