Safety and effectiveness of the Vibrant Soundbridge in treating conductive and mixed hearing loss: A systematic review

Objectives/hypothesis: For many years, the therapeutic approach for conductive and/or mixed hearing loss has consisted of middle ear surgery with replacement of defect ossicles, and if possible the application of a hearing aid. Advances in technology have led to the introduction of electronmagnetic active implantable devices such as the Vibrant Soundbridge (VSB). With its various coupling techniques for different pathophysiological situations in the middle ear, the VSB offers greater improvement in the hearing performance of affected persons.

Data source: PubMed, OvidSP (MEDLINE), EMBASE (DIMDI), the National Institue for Health research (NIHR) Centre for Reviews and Dissemination (including the National Health Service Economic Evaluation Database, Database of Abstracts of Reviews of Effects, and Health Technology Assessment), and the Cochrane Library were searched to identify articles published between January 2006 and April 2014 that evaluated the safety and effectiveness of the VSB in comparison to no intervention, bone conduction hearing implants (BCHI), and middle ear surgery plus hearing aids for adults and children with conductive or mixed hearing loss.

Methods: Study selection and data extraction was carried out by multiple reviewers. Study quality was assessed using the Oxford Centre for Evidence-Based Medicine levels of evidence (2011); and a checklist available from the Evidence Analysis Library, Academy of Nutrition and Diabetics.

Results: Thirty-six publications were identified: 19 on VSB outcomes in 294 individuals, 13 on BCHI outcomes in 666 individuals, and four on middle ear surgery plus hearing aid outcomes in 43 individuals. Two systematic reviews were also identified. Heterogeneous outcome measures made it difficult to summarize data. In general, the VSB proved to be safe and effective when compared to no intervention and BCHI, and provided more and consistent hearing gain compared to middle ear surgery plus conventional hearing aids.

Conclusion: As demonstrated in the literature, the VSB as an active device offers an effective alternative for patients with various middle ear pathologies, particularly with mixed hearing loss and failed previous tympanoplasties when classical ossiculoplasty could not provide enough functional gain. This new strategy in hearing rehabilitation has led to an improved quality of hearing and life. Laryngoscope, 126:1451-1457, 2016.