耳鼻科ジャーナル

A Systematic Review of the Safety and Effectiveness of the Vibrant Soundbridge

Kristin Klein, Alexa Nardelli and Tania Stafinski

A Systematic Review of the Safety and Effectiveness of the Vibrant Soundbridge

Objective: To examine the current state of the science related to the safety and effectiveness of the Vibrant Soundbridge middle ear implant in the treatment of hearing loss.

Data Sources: MEDLINE, EMBASE, The Cochrane Library, Web of Science, CINAHL, PsycINFO and the Centre for Reviews and Dissemination were searched without date or language limits.

Study Selection: Titles and abstracts of 7700 citations were screened and 69 articles selected for full review, of which 44 studies involving a total 832 patients met the study’s eligibility criteria.

Data Extraction: Information was extracted using a pre-tested data abstraction form and study quality was assessed using the Oxford Centre for Evidence-Based Medicine Levels of Evidence.

Data Synthesis: Due to heterogeneity across studies, metaanalysis was not performed and comparisons were made by structured review.

Conclusion: Of the studies that compared the VSB to conventional hearing aids, the majority reported statistically significant improvements in functional gain, speech reception, and quality of life with the VSB. Regarding speech recognition, the findings were mixed. Among studies that compared the VSB to the unaided condition, there was clinical benefit observed in all categories with the device. Adverse event rates were reasonably low, although VSB implantation poses a significant risk compared to non-invasive treatment with conventional hearing aids. The Vibrant Soundbridge middle ear implant appears to offer a safe and effective alternative for patients able and unable to wear conventional hearing aids.