Direct round window stimulation with the Med-El Vibrant Soundbridge: 5 years of experience using a technique without interposed fascia

Abstract

The objective of this study was to present 5 years of surgical experience, and the extended results of hearing preservation (based on 3-year follow-up), with the Med-El Vibrant Soundbridge (VSB) in which the floating mass transducer (FMT) is placed directly against the round window membrane, and the fascia is used only as covering tissue to keep it in position. A retrospective survey of surgical and audiological data was conducted to evaluate the performance and stability of patient hearing, with audiometric measurements performed over fixed time intervals up to 36 months. 21 patients, aged 19–62 years (mean 48.4), with mixed or conductive, bilateral or unilateral hearing loss were included in this study. Surgical intervention involved monaural implantation of the Med-El VSB between 2006 and 2009. The results were assessed using pure tone audiometry. In 5 years of experience with the technique, no significant complications or device extrusion were observed except for two revision surgeries requiring FMT repositioning. In the 3-year follow-up, we observed stable hearing in the implanted ear. It is concluded that direct round window stimulation without interposed fascia is an alternative for patients with hearing impairment caused by chronic otitis media and/or lack of ossicles, especially after modified radical mastoidectomy. It allows good results in a selected group of patients, although further observation on a larger population is needed to confirm long-term validity and effectiveness.

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

“…Schraven et al [2016] report on high revision surgery numbers of up to 71% in RW vibroplasty without coupler usage. We observed a revision surgery rate of 11% in the RW coupler group (1/9) which is in agreement with previous works [Skarzynski et al, 2014;Zhao et al, 2016]. Although an ossicular attachment point for the FMT is surgically less challenging than RW vibroplasty which requires drilling of the RW niche, RW vibroplasty using the RW coupler is the best alternative for cases where no ossicular chain is present.…”

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

“…Careful drilling to widen the RW niche is often required, which could be one drawback to this approach. In comparison with this technique [Colletti et al, 2013;Skarzynski et al, 2014], the RW coupler may improve vibroplasty by adding a more stable substance to the fascia or cartilage (or eliminating the need for it), while also reducing the amount of drilling at the RW niche [Lüers and Hütten-brink, 2014]. Schwab et al [2013] state that using the RW coupler is a safer and more effective surgical procedure.…”

“…According to the literature [Böheim et al, 2012;Skarzynski et al, 2014], audiometric thresholds have been reported to be stable 12 months postoperatively, with aided performance significantly improved over preoperative measurements. Additionally, basic audiological tests showed that the air and BC thresholds of the patients were not altered by the operation.…”

“…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.…”

Round Window Stimulation for Conductive and Mixed Hearing Loss

“…Stability of the FMT in the round window niche may be maintained by bracing the FMT to the hypotympanum (17). However, Skarzynski et al (18) reported no significant difference in bone conduction thresholds after 36 months when placing the FMT directly on the round window and only using fascia to cover the FMT. In this cohort, three subjects (S3, S7, and S9) required revision surgery during the study period due to displacement of the FMT from the round window niche.…”