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Sound Source Localization Testing in Single-sided Deafness Following Bone Conduction Intervention
Published on: December 20, 2024
767
Adverse events associated with bone-conduction and middle-ear implants: a systematic review
Burkard Schwab1, Wilhelm Wimmer2, Johan L Severens3
1Klinik für Hals-Nasen-Ohrenheilkunde, Helios Klinikum Hildesheim, Senator-Braun-Allee 33, 31135, Hildesheim, Germany. Burkard.Schwab@helios-gesundheit.de.
Summary
Adverse events associated with bone-conduction hearing implants (BCHIs) and active middle-ear implants (aMEIs) vary by device, with low reporting quality noted. However, these implantable devices are generally safe for treating hearing loss.
Area of Science:
- Otolaryngology
- Biomedical Engineering
- Medical Device Safety
Background:
- Bone-conduction hearing implants (BCHIs) and active middle-ear implants (aMEIs) offer solutions for hearing loss.
- Understanding the safety profile of these devices is crucial for clinical decision-making.
Purpose of the Study:
- To review the types and frequencies of adverse events (AEs) associated with BCHIs and aMEIs.
- To assess the quality of AE reporting in the scientific literature.
Main Methods:
- Systematic literature search of Cochrane, PubMed, and EMBASE (1996-2016).
- Inclusion of primary articles with ≥5 patients, in English or German.
- Tabulation and statistical analysis of study characteristics, demographics, and AE counts.
Main Results:
- Reporting quality of AEs for BCHIs and aMEIs is often low.
- AEs differ qualitatively and in frequency across various BCHI and aMEI devices.
- Cumulative incidence of minor and major AEs was reported for subsets of studies.
Conclusions:
- Despite variable reporting quality and differing AE profiles, BCHIs and aMEIs are safe treatment options.
- Improved AE reporting guidelines are needed for future research.
- Implantable hearing solutions demonstrate a favorable safety profile.
