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The development of active middle ear implants: A historical perspective and clinical outcomes
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 co...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley & Sons, Inc.
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6209610/ https://www.ncbi.nlm.nih.gov/pubmed/30410994 http://dx.doi.org/10.1002/lio2.215 |
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author | Kließ, Melodi Koşaner Ernst, Arne Wagner, Jan Mittmann, Philipp |
author_facet | Kließ, Melodi Koşaner Ernst, Arne Wagner, Jan Mittmann, Philipp |
author_sort | Kließ, Melodi Koşaner |
collection | PubMed |
description | 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: |
format | Online Article Text |
id | pubmed-6209610 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | John Wiley & Sons, Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-62096102018-11-08 The development of active middle ear implants: A historical perspective and clinical outcomes Kließ, Melodi Koşaner Ernst, Arne Wagner, Jan Mittmann, Philipp Laryngoscope Investig Otolaryngol Otology, Neurotology, and Neuroscience 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: John Wiley & Sons, Inc. 2018-10-06 /pmc/articles/PMC6209610/ /pubmed/30410994 http://dx.doi.org/10.1002/lio2.215 Text en © 2018 The Authors. Laryngoscope Investigative Otolaryngology published by Wiley Periodicals, Inc. on behalf of The Triological Society This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Otology, Neurotology, and Neuroscience Kließ, Melodi Koşaner Ernst, Arne Wagner, Jan Mittmann, Philipp The development of active middle ear implants: A historical perspective and clinical outcomes |
title | The development of active middle ear implants: A historical perspective and clinical outcomes |
title_full | The development of active middle ear implants: A historical perspective and clinical outcomes |
title_fullStr | The development of active middle ear implants: A historical perspective and clinical outcomes |
title_full_unstemmed | The development of active middle ear implants: A historical perspective and clinical outcomes |
title_short | The development of active middle ear implants: A historical perspective and clinical outcomes |
title_sort | development of active middle ear implants: a historical perspective and clinical outcomes |
topic | Otology, Neurotology, and Neuroscience |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6209610/ https://www.ncbi.nlm.nih.gov/pubmed/30410994 http://dx.doi.org/10.1002/lio2.215 |
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