Burkard Schwab1, Wilhelm Wimmer2, Johan L Severens3, Marco D Caversaccio4. 1. Klinik für Hals-Nasen-Ohrenheilkunde, Helios Klinikum Hildesheim, Senator-Braun-Allee 33, 31135, Hildesheim, Germany. Burkard.Schwab@helios-gesundheit.de. 2. ARTORG Center for Biomedical Engineering Research, University of Bern, Murtenstrasse 50, 3008, Bern, Switzerland. 3. Erasmus School for Health Policy and Management and Institute for Medical Technology Assessment, Erasmus University Rotterdam, Burgemeester Oudlaan 50, 3062, Rotterdam, The Netherlands. 4. Universitätsklinik für HNO, Kopf- und Halschirurgie, Inselspital Bern, Freiburgstrasse, 3010, Bern, Switzerland.
Abstract
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.
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.
Authors: Alexander M Huber; Bernd Strauchmann; Marco D Caversaccio; Wilhelm Wimmer; Thomas Linder; Nicola De Min; John-Martin Hempel; Marlene Pollotzek; Henning Frenzel; Frauke Hanke; Christof Röösli Journal: Otol Neurotol Date: 2022-02-01 Impact factor: 2.311