Long-Term Outcomes of Vibroplasty Coupler Implantations to Treat Mixed/Conductive Hearing Loss

Zahnert, Thomas; Mlynski, Robert; Löwenheim, Hubert; Beutner, Dirk; Hagen, Rudolf; Ernst, Arneborg; Zehlicke, Thorsten; Kühne, Hilke; Friese, Natascha; Tropitzsch, Anke; Lüers, Jan Christoffer; Todt, Ingo; Hüttenbrink, Karl-Bernd

doi:10.1159/000495560

Cited by 20 publications

(43 citation statements)

References 31 publications

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“…Previous reports have analyzed the safety of the VSB, 6,7,17 we have further supported its safety by comparing pre- and postoperative BC thresholds, which was in line with previous reports in the literature. For patients with CAA, Roman et al reported that the average BC threshold did not differ pre- and postoperatively when FMT was positioned on the stapes and the incus.…”

Section: Discussionsupporting

confidence: 89%

“…7 Recently, another multicenter, prospective study suggested that mean postoperative BC thresholds remained stable at the long-term follow-up. 6 These results demonstrated that the function of the inner ear was not affected by implantation of the Clip coupler. Therefore, we confirmed that the VSB with the Clip coupler connected to the stapes head was a safe semi-implantation device for patients with CAA.…”

Section: Discussionmentioning

confidence: 73%

“…The floating mass transducer (FMT) is the core component of the VSB device, which is attached to the round window (RW), oval window, passive middle ear prosthesis, or third window through diverse vibroplasty couplers. 6,11 It has been reported in a temporal bone experiment that the Clip vibroplasty can be connected to the stapes, demonstrating the general usability of the FMT. 12 Investigations of the velocity spectrum of the stapes footplate using laser Doppler vibrometer measurements have shown that the significant improvements in the mechanical and functional responses of the middle ear are attributable to the attachment of the Clip coupler to the stapes head in temporal bone experiments.…”

Section: Introductionmentioning

confidence: 93%

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Long-term Outcomes of Clip Coupler Implantation in Patients with Unilateral Congenital Aural Atresia

Zhao

Yang

Liu

et al. 2020

Ann Otol Rhinol Laryngol

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Objective: To evaluate the long-term safety and efficacy of the Clip coupler attached to the stapes head in patients with unilateral congenital aural atresia (CAA). Methods: This single-center retrospective study included 16 Mandarin-speaking patients who had unilateral microtia accompanied by CAA. All patients were divided into two groups: the short-term follow-up group (n = 9) and the long-term follow-up group (n = 7). The floating mass transducer of the Vibrant Soundbridge (VSB) was positioned in the stapes head by the Clip coupler. The safety of the VSB was investigated by comparing preoperative and postoperative bone-conduction (BC) thresholds as well as by complications. The effectiveness was evaluated by functional gain (FG), word recognition score (WRS), speech reception threshold (SRT) and signal-to-noise ratio (SNR). Results: Pre- and post-operative BC thresholds were no different in all patients. And no complications developed. VSB-aided thresholds in the free-field had improved significantly in both short- and long-term follow-up groups. The improvements of WRS were observed in two groups. The monosyllabic VSB-aided WRS in the long-term follow-up group was significantly higher than that in the short-term follow-up group. When speech was from the impaired ear and noise presented to the side of normal ear (SVSBNCL), lower SNRs were found in two groups after VSB implantation. However, there was no statistical difference in aided SNR between the two groups at SVSBNCL status. Conclusions: Our results show that the FMT connected to the stapes head is a secure and useful device for patients with unilateral CHL/MHL, not only in terms of improved hearing thresholds, but also improved speech intelligibility in quiet and noisy environments.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionmentioning

confidence: 73%

Section: Introductionmentioning

confidence: 93%

See 1 more Smart Citation

Long-term Outcomes of Clip Coupler Implantation in Patients with Unilateral Congenital Aural Atresia

Zhao

Yang

Liu

et al. 2020

Ann Otol Rhinol Laryngol

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“…It is well known, that restoration of hearing using hearing aids has a positive impact on HRQoL [ 40 , 41 ]. In addition, there are multiple studies describing an improvement of HRQoL after hearing restoration with active bone conduction or middle ear implants [ 42 , 43 ]. Nevertheless, these implants do not aim to replace successful hearing restoration in middle ear surgery [ 44 ].…”

Section: Discussionmentioning

confidence: 99%

Mapping the ChOLE classification to hearing outcomes and disease-specific health-related quality of life

Weiss

Bächinger

Rrahmani

et al. 2020

Eur Arch Otorhinolaryngol

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Objectives To investigate the association between the “ChOLE” classification, hearing outcomes and disease-specific health-related quality of life (HRQoL). Methods In two tertiary referral centers, patients requiring primary or revision surgery for cholesteatoma were assessed for eligibility. Audiometric assessment was performed pre- and postoperatively. The ChOLE classification was determined intraoperatively and via the preoperative CT scan. HRQoL was assessed pre- and postoperatively using the Zurich Chronic Middle Ear Inventory (ZCMEI-21). Results A total of 87 patients (mean age 45.2 years, SD 16.2) were included in this study. ChOLE stage I cholesteatoma was found in 8 (9%), stage II cholesteatoma was found in 65 (75%), and stage III cholesteatoma was found in 14 (16%) patients. Postoperatively, the mean air–bone gap (0.5, 1, 2, 3 kHz) was significantly smaller than before surgery (14.3 dB vs. 23.0 dB; p = 0.0007). The mean ZCMEI-21 total score significantly decreased after surgery (26.8 vs. 20.7, p = 0.004). No correlation between the ZCMEI-21 total score and both the ChOLE stage and the extent of the cholesteatoma (ChOLE subdivision “Ch”) was found. A trend towards worse HRQoL associated with a poorer status of the ossicular chain (ChOLE subdivision “O”) was observed. The audiometric outcomes were not associated with the extent of the cholesteatoma. The ChOLE subdivision describing the ossicular status showed a strong association with the pre- and postoperative air conduction (AC) thresholds. Further, the ZCMEI-21 total score and its hearing subscore correlated with the AC thresholds. Conclusion The ChOLE classification does not show a clear association with HRQoL measured by the ZCMEI-21. The HRQoL neither seems to be associated with the extent of the disease nor with the ossicular chain status. Yet, surgical therapy significantly improved HRQoL by means of reduced ZCMEI-21 total scores, which were strongly associated with the AC thresholds. Intraoperative assessment of a cholesteatoma using the ChOLE classification and HRQoL complement each other and provide useful information.

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“…Additional coupling techniques were developed leading to new applications of the AMEI also allowing the treatment of CHL and MHL. Techniques for various FMT placements with and without couplers have been summarized in detail and proven to be stable over time [ 6 – 8 ].…”

Section: Introductionmentioning

confidence: 99%

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

Rahne

Skarżyński

Hagen

et al. 2020

Eur Arch Otorhinolaryngol

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

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Long-Term Outcomes of Vibroplasty Coupler Implantations to Treat Mixed/Conductive Hearing Loss

Cited by 20 publications

References 31 publications

Long-term Outcomes of Clip Coupler Implantation in Patients with Unilateral Congenital Aural Atresia

Long-term Outcomes of Clip Coupler Implantation in Patients with Unilateral Congenital Aural Atresia

Mapping the ChOLE classification to hearing outcomes and disease-specific health-related quality of life

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

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