Adverse events associated with bone-conduction and middle-ear implants: a systematic review

Schwab, Burkard; Wimmer, Wilhelm; Severens, Johan L.; Caversaccio, Marco D.

doi:10.1007/s00405-019-05727-8

Adverse events associated with bone-conduction and middle-ear implants: a systematic review

Otology
Published: 20 November 2019

Volume 277, pages 423–438, (2020)
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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.

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References

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Acknowledgements

The authors would like to thank the Clinical Research Department of MED-EL Medical Electronics (Innsbruck, Austria) for performing the literature search and data extraction.

Author information

Authors and Affiliations

Klinik für Hals-Nasen-Ohrenheilkunde, Helios Klinikum Hildesheim, Senator-Braun-Allee 33, 31135, Hildesheim, Germany
Burkard Schwab
ARTORG Center for Biomedical Engineering Research, University of Bern, Murtenstrasse 50, 3008, Bern, Switzerland
Wilhelm Wimmer
Erasmus School for Health Policy and Management and Institute for Medical Technology Assessment, Erasmus University Rotterdam, Burgemeester Oudlaan 50, 3062, Rotterdam, The Netherlands
Johan L. Severens
Universitätsklinik für HNO, Kopf- und Halschirurgie, Inselspital Bern, Freiburgstrasse, 3010, Bern, Switzerland
Marco D. Caversaccio

Authors

Burkard Schwab
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Wilhelm Wimmer
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Johan L. Severens
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Marco D. Caversaccio
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Corresponding author

Correspondence to Burkard Schwab.

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Conflict of interest

The authors declare a potential conflict of interest given that literature search, screening, and data extraction were performed by the Clinical Research Department of one manufacturer (MED-EL, Austria). All steps of this literature review followed Cochrane guidelines and are reported in a transparent way. Raw data are provided as Electronic Supplementary Material (Online Resources). The following authors have received funding from manufacturers mentioned in this review: BS was supported by MED-EL and Cochlear. MC and WW, with the Department of ORL, Head and Neck Surgery and the Artorgcenter, University Bern were supported by MED-EL, Cochlear and Oticon Medical. JS has not received any kind of support from any of the manufacturers mentioned in this review.

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Appendices

Appendix A: Search string

Middle ear implant OR aMEI OR Vibroplasty OR middle ear surgery OR implantable hearing aid OR Carina OR Direct acoustic cochlear implant OR DACI OR Direct acoustic cochlear stimulator OR DACS OR Direct acoustic cochlear implant actuator OR CODACS OR Middle ear transducer OR Envoy OR MAXUM OR ear reconstruction surgery OR SOUNDBRIDGE OR Floating mass transducer OR FMT OR Soundtec OR bone conduction implant OR bone conduction hearing implant OR bone conduction device OR bone conduction hearing device OR bone conduction hearing aid OR BCHI OR BCHA OR bone anchored hearing implant OR bone anchored hearing device OR bone anchored hearing aid OR Baha OR Ponto OR BONEBRIDGE OR Sophono OR safety OR adverse event OR complications OR revision AND hearing loss NOT Systematic Review NOT case report NOT cochlear implant.

Appendix B: Summary statistics of Ratio of events to ears (REE) for minor and major events, by AE category

Device	AE supercategory	AE category	Median	Mean	SD	Min.	Max.
BAHA Attract	Major	Device	0	0	0	0	0
BAHA Connect	Major	Device	0	0.02	0.1	0	1.07
Bonebridge	Major	Device	0	0	0	0	0
Carina	Major	Device	0.09	0.12	0.14	0	0.39
CODACS	Major	Device	0	0	0	0	0
Esteem	Major	Device	0	0	0	0	0
MET	Major	Device	0.1	0.19	0.25	0	0.56
Ponto	Major	Device	0.04	0.07	0.09	0	0.23
Sophono	Major	Device	0	0.01	0.04	0	0.13
Soundbridge	Major	Device	0	0.02	0.08	0	0.54
Soundtech	Major	Device	0	0	0	0	0
BAHA Attract	Major	Not specified	0	0.01	0.02	0	0.04
BAHA Connect	Major	Not specified	0.02	0.08	0.14	0	0.85
Bonebridge	Major	Not specified	0	0.03	0.05	0	0.17
Carina	Major	Not specified	0	0.09	0.11	0	0.3
CODACS	Major	Not specified	0.11	0.14	0.05	0.11	0.2
Esteem	Major	Not specified	0.25	0.37	0.42	0	1.14
MET	Major	Not specified	0.08	0.18	0.26	0	0.56
Ponto	Major	Not specified	0	0.02	0.04	0	0.1
Sophono	Major	Not specified	0	0.02	0.05	0	0.15
Soundbridge	Major	Not specified	0	0.03	0.06	0	0.23
Soundtech	Major	Not specified	0	0	0	0	0
BAHA Attract	Major	Patient	0	0	0	0	0
BAHA Connect	Major	Patient	0	0.03	0.05	0	0.32
Bonebridge	Major	Patient	0	0	0	0	0
Carina	Major	Patient	0	0	0	0	0
CODACS	Major	Patient	0	0	0	0	0
Esteem	Major	Patient	0	0	0	0	0
MET	Major	Patient	0	0.05	0.1	0	0.2
Ponto	Major	Patient	0	0	0	0	0
Sophono	Major	Patient	0	0	0	0	0
Soundbridge	Major	Patient	0	0.01	0.02	0	0.11
Soundtech	Major	Patient	0	0	0	0	0
BAHA Attract	Major	Skin	0	0	0	0	0
BAHA Connect	Major	Skin	0.05	0.1	0.14	0	0.64
Bonebridge	Major	Skin	0	0	0	0	0
Carina	Major	Skin	0	0.02	0.05	0	0.18
CODACS	Major	Skin	0	0	0	0	0
Esteem	Major	Skin	0	0.02	0.04	0	0.1
MET	Major	Skin	0.03	0.03	0.04	0	0.08
Ponto	Major	Skin	0.03	0.04	0.03	0	0.08
Sophono	Major	Skin	0	0.01	0.02	0	0.07
Soundbridge	Major	Skin	0	0	0.02	0	0.14
Soundtech	Major	Skin	0	0	0	0	0
BAHA Attract	Major	Surgery	0	0	0	0	0
BAHA Connect	Major	Surgery	0	0	0	0	0
Bonebridge	Major	Surgery	0	0	0	0	0
Carina	Major	Surgery	0	0	0.01	0	0.03
CODACS	Major	Surgery	0.11	0.08	0.07	0	0.13
Esteem	Major	Surgery	0	0	0	0	0
MET	Major	Surgery	0	0.02	0.04	0	0.08
Ponto	Major	Surgery	0	0	0	0	0
Sophono	Major	Surgery	0	0	0	0	0
Soundbridge	Major	Surgery	0	0.03	0.07	0	0.29
Soundtech	Major	Surgery	0	0	0	0	0
BAHA Attract	Minor	Device	0	0.09	0.18	0	0.5
BAHA Connect	Minor	Device	0	0.02	0.13	0	1.29
Bonebridge	Minor	Device	0	0	0	0	0
Carina	Minor	Device	0	0.04	0.14	0	0.45
CODACS	Minor	Device	0	0	0	0	0
Esteem	Minor	Device	0	0.02	0.04	0	0.1
MET	Minor	Device	0	0.13	0.26	0	0.53
Ponto	Minor	Device	0	0	0	0	0
Sophono	Minor	Device	0	0.12	0.24	0	0.83
Soundbridge	Minor	Device	0	0.01	0.05	0	0.4
Soundtech	Minor	Device	0	0	0	0	0
BAHA Attract	Minor	Not specified	0	0	0	0	0
BAHA Connect	Minor	Not specified	0	0	0.04	0	0.38
Bonebridge	Minor	Not specified	0	0	0	0	0
Carina	Minor	Not specified	0	0.01	0.02	0	0.08
CODACS	Minor	Not specified	0	0.04	0.06	0	0.11
Esteem	Minor	Not specified	0	0.13	0.33	0	0.81
MET	Minor	Not specified	0	0	0	0	0
Ponto	Minor	Not specified	0	0	0	0	0
Sophono	Minor	Not specified	0	0	0	0	0
Soundbridge	Minor	Not specified	0	0	0.01	0	0.11
Soundtech	Minor	Not specified	0	0	0	0	0
BAHA Attract	Minor	Patient	0.15	0.19	0.22	0	0.6
BAHA Connect	Minor	Patient	0	0.02	0.07	0	0.47
Bonebridge	Minor	Patient	0	0.02	0.04	0	0.1
Carina	Minor	Patient	0	0.01	0.03	0	0.1
CODACS	Minor	Patient	0	0.04	0.08	0	0.13
Esteem	Minor	Patient	0.04	0.14	0.23	0	0.58
MET	Minor	Patient	0	0.12	0.24	0	0.47
Ponto	Minor	Patient	0	0.07	0.14	0	0.38
Sophono	Minor	Patient	0.12	0.12	0.13	0	0.38
Soundbridge	Minor	Patient	0	0.03	0.07	0	0.31
Soundtech	Minor	Patient	0	0.08	0.13	0	0.23
BAHA Attract	Minor	Skin	0.06	0.1	0.12	0	0.33
BAHA Connect	Minor	Skin	0.13	0.27	0.34	0	1.73
Bonebridge	Minor	Skin	0	0.06	0.08	0	0.22
Carina	Minor	Skin	0	0	0	0	0
CODACS	Minor	Skin	0	0.02	0.03	0	0.05
Esteem	Minor	Skin	0.02	0.06	0.07	0	0.15
MET	Minor	Skin	0	0.05	0.11	0	0.21
Ponto	Minor	Skin	0.24	0.31	0.21	0.17	0.77
Sophono	Minor	Skin	0.17	0.18	0.17	0	0.47
Soundbridge	Minor	Skin	0	0.02	0.06	0	0.4
Soundtech	Minor	Skin	0	0.03	0.05	0	0.09
BAHA Attract	Minor	Surgery	0	0.25	0.34	0	0.8
BAHA Connect	Minor	Surgery	0	0.01	0.06	0	0.5
Bonebridge	Minor	Surgery	0	0.01	0.02	0	0.08
Carina	Minor	Surgery	0	0.1	0.21	0	0.67
CODACS	Minor	Surgery	0.21	0.16	0.14	0	0.27
Esteem	Minor	Surgery	0.34	0.38	0.37	0	0.93
MET	Minor	Surgery	0	0.01	0.03	0	0.05
Ponto	Minor	Surgery	0	0.02	0.05	0	0.13
Sophono	Minor	Surgery	0	0.02	0.05	0	0.17
Soundbridge	Minor	Surgery	0	0.07	0.15	0	0.86
Soundtech	Minor	Surgery	0.26	0.29	0.21	0.11	0.51

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Schwab, B., Wimmer, W., Severens, J.L. et al. Adverse events associated with bone-conduction and middle-ear implants: a systematic review. Eur Arch Otorhinolaryngol 277, 423–438 (2020). https://doi.org/10.1007/s00405-019-05727-8

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Received: 25 June 2019
Accepted: 07 November 2019
Published: 20 November 2019
Issue Date: February 2020
DOI: https://doi.org/10.1007/s00405-019-05727-8

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Adverse events associated with bone-conduction and middle-ear implants: a systematic review