AI Article Synopsis
- Energy emitting active middle ear implants (aMEI) have developed over two decades, achieving both medical safety and regulatory approval, making them valuable for various types of hearing loss.
- * A systematic literature review analyzed 431 studies on the safety and efficacy of partially implantable aMEIs, noting that clinical safety concerns and economic factors hinder market access despite good audiological outcomes.
- * Most research focuses on the VIBRANT SOUNDBRIDGE system, which shows promising results across different conditions, while the MAXUM and MET systems are less established in surgical practice.
Article Abstract
Objective S: Energy emitting, active middle ear implants (aMEI) have taken more than two decades of research to reach technological sophistication, medical safety, and regulatory approval to become a powerful tool in treating sensorineural, conductive, and mixed hearing loss. The present review covers this era.
Data Source: Literature found from searching Pubmed (MEDLINE); EMBASE, SciSearch, German Medical Science Journals and Meetings, and The Cochrane Library; and published as of February 2017. Study bibliographies were hand-searched to find further materials.
Methods: A systematic literature review was conducted to identify studies evaluating the safety, efficacy, effectiveness, and subjective outcomes of partially implantable aMEIs. Data were extracted on systems with regulatory approval and summarized narratively. Meta-analyses were conducted for aMEIs with more than 25 publications. Study selection, data extraction, and quality appraisal for quantitative data synthesis was carried out by two reviewers.
Results: Four hundred thirty-one studies included in narrative synthesis describe that albeit good audiological outcomes, clinical safety and (dis)investment are major barriers to continued market access. The synthesised risk of adverse events was three fold with the MET than with the VIBRANT SOUNDBRIDGE. With the latter system, audiological outcomes were stable and similar for all indications and age groups.
Conclusion: To date, the majority of the literature covers the clinical application of the VIBRANT SOUNDBRIDGE system as it is applicable to a wide range of otologic and audiological conditions, particularly with the introduction of couplers to extend its clinical reach. The MAXUM and MET still have to find their way into surgical routine.Level of Evidence.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6209610 | PMC |
| http://dx.doi.org/10.1002/lio2.215 | DOI Listing |
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