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Systematic review to evaluate the safety, efficacy and economical outcomes of the Vibrant Soundbridge for the treatment of sensorineural hearing loss

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Abstract

Introduced in the late 90s, the active middle ear implant Vibrant Soundbridge (VSB) is nowadays used for hearing rehabilitation in patients with mild to severe sensorineural hearing loss (SNHL) unable to tolerate conventional hearing aids. In experienced hands, the surgical implantation is fast done, safe and highly standardized. Here, we present a systematic review, after more than 15 years of application, to determine the efficacy/effectiveness and cost-effectiveness, as well as patient satisfaction with the VSB active middle ear implant in the treatment of mild to severe SNHL. A systematic search of electronic databases, investigating the safety and effectiveness of the VSB in SNHL plus medical condition resulted in a total of 1640 papers. After removing duplicates, unrelated articles, screening against inclusion criteria and after in-depth screening, the number decreased to 37 articles. 13 articles were further excluded due to insufficient outcome data. 24 studies remained to be systematically reviewed. Data was searched on safety, efficacy and economical outcomes with the VSB. Safety-oriented outcomes included complication/adverse event rates, damage to the middle/inner ear, revision surgery/explant rate/device failure and mortality. Efficacy outcomes were divided into audiological outcomes, including hearing thresholds, functional gain, speech perception in quiet and noise, speech recognition thresholds, real ear insertion gain and subjective outcomes determined by questionnaires and patient-oriented scales. Data related to quality of life (QALY, ICER) were considered under economical outcomes. The VSB turns out to be a highly reliable and a safe device which significantly improves perception of speech in noisy situations with a high sound quality. In addition, the subjective benefit of the VSB was found to be mostly significant in all studies. Finally, implantation with the VSB proved to be a cost-effective and justified health care intervention.

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Authors and Affiliations

  1. Department of Otolaryngology, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany

    Karl-Ludwig Bruchhage, Anke Leichtle, Henning Frenzel & Barbara Wollenberg

  2. Department of Phoniatrics and Pediatric Audiology, University of Lübeck, Ratzeburger Allee 160, 23538, Lübeck, Germany

    Rainer Schönweiler

  3. Department of Otolaryngology, Unfallkrankenhaus Berlin, 12683, Berlin, Germany

    Ingo Todt

  4. Department of Otorhinolaryngology, Medical School, University of Vienna, Waehringer Guertel 18-20, 1097, Vienna, Austria

    Wolf-Dieter Baumgartner

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  1. Karl-Ludwig Bruchhage
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  2. Anke Leichtle
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Correspondence to Karl-Ludwig Bruchhage.

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Bruchhage, KL., Leichtle, A., Schönweiler, R. et al. Systematic review to evaluate the safety, efficacy and economical outcomes of the Vibrant Soundbridge for the treatment of sensorineural hearing loss. Eur Arch Otorhinolaryngol 274, 1797–1806 (2017). https://doi.org/10.1007/s00405-016-4361-2

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