International consensus on Vibrant Soundbridge® implantation in children and adolescents

Cremers, C.W.R.J.; O’Connor, Alec Fitzgerald; Helms, J.; Roberson, Joseph B.; Clarós, Pedro; Frenzel, H; Profant, Milan; Schmerber, S.; Streitberger, Christian; Baumgartner, Wolf‐Dieter; Orfila, Daniel; Pringle, Märit; Cenjor, Carlos; Giarbini, Nadia; Jiang, Dan; Snik, A.F.M.

doi:10.1016/j.ijporl.2010.07.028

Cited by 74 publications

(50 citation statements)

References 12 publications

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“…The first patient was successfully implanted in Italy and another was implanted in Germany for conductive hearing loss (CHL) due to bilateral microtia . CE marking for these indications was granted in 2009 . Recently, the VSB has shown to be effective in reducing the perceived levels of tinnitus and has started to be explored as an alternative for managing balance problems together with SNHL…”

Section: Resultsmentioning

confidence: 99%

The development of active middle ear implants: A historical perspective and clinical outcomes

Kließ

Ernst

Wagner

et al. 2018

Laryngoscope Investig Oto

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Objective (s)Energy emitting, active middle ear implants (aMEI) have taken more than two decades of research to reach technological sophistication, medical safety, and regulatory approval to become a powerful tool in treating sensorineural, conductive, and mixed hearing loss. The present review covers this era.Data SourceLiterature found from searching Pubmed (MEDLINE); EMBASE, SciSearch, German Medical Science Journals and Meetings, and The Cochrane Library; and published as of February 2017. Study bibliographies were hand‐searched to find further materials.MethodsA systematic literature review was conducted to identify studies evaluating the safety, efficacy, effectiveness, and subjective outcomes of partially implantable aMEIs. Data were extracted on systems with regulatory approval and summarized narratively. Meta‐analyses were conducted for aMEIs with more than 25 publications. Study selection, data extraction, and quality appraisal for quantitative data synthesis was carried out by two reviewers.ResultsFour hundred thirty‐one studies included in narrative synthesis describe that albeit good audiological outcomes, clinical safety and (dis)investment are major barriers to continued market access. The synthesised risk of adverse events was three fold with the MET than with the VIBRANT SOUNDBRIDGE. With the latter system, audiological outcomes were stable and similar for all indications and age groups.ConclusionTo date, the majority of the literature covers the clinical application of the VIBRANT SOUNDBRIDGE system as it is applicable to a wide range of otologic and audiological conditions, particularly with the introduction of couplers to extend its clinical reach. The MAXUM and MET still have to find their way into surgical routine.Level of Evidence:

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Section: Resultsmentioning

confidence: 99%

The development of active middle ear implants: A historical perspective and clinical outcomes

Kließ

Ernst

Wagner

et al. 2018

Laryngoscope Investig Oto

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“…The VSB can be implanted in children up from the age of 5 years as stated by an international consensus paper (14). In fact, the VSB has even been implanted in newborns with atretic ears showing good audiologic and clinical results at a follow-up time of 42 months (15).…”

Section: Indications For the Vsbmentioning

confidence: 99%

Vibroplasty for Mixed and Conductive Hearing Loss

Lüers

Hüttenbrink²,

Zahnert³

et al. 2013

Otology &Amp; Neurotology

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Modern application methods of an active middle ear implant (VSB) open new therapeutic options for patients with various outer and middle ear diseases resulting in conductive or mixed hearing loss. Titanium couplers can help to couple the active middle ear implant in a standardized way to remnants of the ossicular chain or to the round window. Thus, the active middle ear implant has been established as an alternative treatment option for patients with mixed and conductive hearing. However, the heterogeneity of the studies published so far complicates the analysis of the audiometric results, and thus, the functional hearing gain after VSB implantation varies a lot.

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“…In June 2009, the Vibrant Soundbridge received approval for patients younger than 18 years of age in the European Union. Reports to date have shown it to be another treatment option in paediatric patients with ear canal atresia and ossicular anomalies by placing the floating mass transducer (FMT) on the long process of the incus, mobile stapes remnants, round or oval window [62]. However, a pre-operative computerised tomography (CT) scan is needed and there is no option of a preoperative headband trial.…”

Section: Vibrant Soundbridgementioning

confidence: 99%