Purpose: To review types and frequencies of adverse events (AE) associated with bone-conduction hearing implants (BCHIs) and active middle-ear implants (aMEIs) as reported in the literature. Methods: Cochrane, PubMed, and EMBASE libraries were searched for primary articles in English or German language that reported on adverse events following BCHI or aMEI implantation, included at least five patients and were published between 1996 and 2016. Study characteristics, demographics, and counts of adverse events were tabulated and analyzed within the R statistical programming environment. Results: Following assessment of the reporting quality of adverse events, we present a brief guideline that potentially improves AE reporting in this field of research. For the full dataset, we summarize study-level adverse event frequencies in terms of ratio of events to ears (REE) by AE groups and by device. For a subset of studies, we also report cumulative incidence (risk) for minor- and major adverse-events by device and by device groups. Conclusions: Data analyzed in this review show that: (1) the reporting quality of adverse events associated with BCHI and aMEIs is often very low; (2) adverse events associated with BCHI and aMEIs are qualitatively different and not equally frequent among devices; (3) state-of-the-art implantable BCHIs and aMEIs are a safe treatment option for hearing loss.

Additional Metadata
Keywords Adverse event, Bone-conduction implant, Hearing loss, Medical device, Middle-ear implant, Safety
Persistent URL dx.doi.org/10.1007/s00405-019-05727-8, hdl.handle.net/1765/121796
Journal European Archives of Oto-Rhino-Laryngology
Citation
Schwab, B. (Burkard), Wimmer, W. (Wilhelm), Severens, J.L, & Caversaccio, M.D. (Marco D.). (2019). Adverse events associated with bone-conduction and middle-ear implants: a systematic review. European Archives of Oto-Rhino-Laryngology. doi:10.1007/s00405-019-05727-8