The Vibrant Soundbridge for Conductive and Mixed Hearing Losses: European Multicenter Study Results

Baumgärtner, W.; Böheim, K.; Hagen, Rudolf; Müller, J. M.; Lenarz, Thomas; Reiss, Steven; Schlögel, Max; Mlynski, Robert; Mojallal, Hamidreza; Colletti, Vittorio; Opie, Jane M.

doi:10.1159/000318521

Cited by 79 publications

(110 citation statements)

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“…This 'RW vibroplasty' -which bypasses a missing or severely damaged ossicular chain entirely and relies solely on the vibrational energy passed through the FMT -has been shown to be safe and effective, with stable results in longterm studies [Baumgartner et al, 2010;Bernardeschi et al, 2011;Böheim et al, 2012;Skarzynski et al, 2014]. However, placing the FMT at the RW often requires drilling and may be complicated by individual differences in RW size, depth of recession, or in cases of RW sclerosis.…”

Section: Introductionmentioning

confidence: 99%

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

et al. 2016

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

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Section: Introductionmentioning

confidence: 99%

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

et al. 2016

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“…However, current publications [Baumgartner et al, 2010;Boeheim et al, 2010;Colletti et al, 2006;Colletti et al, 2009;Cuda et al, 2009;Frenzel et al, 2009;Kiefer and Staudenmaier, 2010;Linder et al, 2009;Streitberger et al, 2009;Wollenberg et al, 2007] reveal a considerable variability regarding the degree of hearing restoration. To approach this issue, different methods of coupling an actuator to the RW membrane have been investigated in human temporal bone experiments [Arnold et al, 2010;Nakajima et al, 2010].…”

Section: Introductionmentioning

confidence: 99%

Conditions for Highly Efficient and Reproducible Round-Window Stimulation in Humans

Schraven¹,

Hirt²,

Goll³

et al. 2011

Audiol Neurotol

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Round-window stimulation is a new clinical approach for the application of active middle-ear implants. To investigate factors influencing the efficiency of round-window stimulation, experiments in 6 human temporal bones were performed with different actuator geometries and coupling conditions. The experiments show that the amplitude ratio between stapes and round-window actuator vibration is most efficient when using a 1.0-mm diameter rod with a 30° inclined tip geometry and an attached silicone pad. In this case, the amplitude ratio is 0.34 for frequencies up to 1.5 kHz and 0.27 for frequencies up to 20 kHz, with a standard deviation of only 4–6 dB at most frequencies. The analysis of data presented here and in a companion paper suggests that control of proper round-window membrane pretension as well as the inclined tip geometry are the major requirements for maximal performance.

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“…The safety of the VSB and the efficiency of the various coupling modalities within the indication range have been established over many years [Fraysse et al, 2001;Mosnier et al, 2008;Baumgartner et al, 2010;Hütten-brink et al, 2010;Zehlicke et al, 2010;Schwab et al, 2012Schwab et al, , 2013Schwab et al, , 2014Maier et al, 2015]. However, it is still unclear which coupling type and FMT position is most effective for the vibration transmission into the cochlear and what variability can be expected.…”

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confidence: 99%

Comparison of Alternative Coupling Methods of the Vibrant Soundbridge Floating Mass Transducer

Busch

Lenarz²,

Maier³

2016

Audiol Neurotol

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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).

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The Vibrant Soundbridge for Conductive and Mixed Hearing Losses: European Multicenter Study Results

Abstract: The VSB, implanted using RW vibroplasty, is a safe and effective treatment for adults with conductive and mixed hearing losses who may have few, if any, other options.

Cited by 79 publications

References 10 publications

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

Conditions for Highly Efficient and Reproducible Round-Window Stimulation in Humans

Comparison of Alternative Coupling Methods of the Vibrant Soundbridge Floating Mass Transducer

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