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      Active transcutaneous bone conduction hearing implants: Systematic review and meta-analysis

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          Abstract

          Background

          In July 2018 the active transcutaneous bone conduction hearing implant received FDA approval in the US (for patients 12 years and older with conductive and/or mixed hearing loss or single-sided deafness), reflecting the current trend of moving away from percutaneous hearing solutions towards intact skin systems.

          Objectives

          To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.

          Data sources

          Literature investigation was performed by electronic database search including PubMed and Cochrane Central Register of Controlled Trials, and manual search of relevant journals and reference lists of included studies.

          Study eligibility criteria

          Randomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.

          Study appraisal and synthesis methods

          Retrieved literature was screened and extracted by two reviewers independently. Subgroup analysis of indications (conductive and/or mixed hearing loss, single-sided deafness) and participant ages (pediatric vs. adults) was conducted on patients with active transcutaneous bone conduction devices. Sensitivity analysis was performed to test the stability of the results in meta-analysis.

          Results

          39 citations reporting on pre- and postoperative audiological results, speech performance in quiet and in noise, localization testing as well as subjective outcomes were included in this systematic review. Functional gain as well as word recognition score outcomes could be further investigated via meta-analysis. All outcomes reported and summarized here reflect beneficial audiological performance and high patient satisfaction, accompanied with a low complications rate (minor event incidence rate: 9.9 person-years; major incidence rate: 148.9 person-years) for the indications of conductive and mixed hearing loss as well as in individuals suffering from single-sided deafness for all age groups of subjects who underwent active transcutaneous bone conduction hearing device implantation.

          Limitations

          A limiting factor of this systematic review was the Level of Evidence of the reviewed literature, comprising 2a/3a studies (cohort studies and case-control studies). Furthermore, the reporting standards, especially in outcomes such as word recognition scores in quiet and in noise, vary across study cites from various countries, which impedes comparisons. Last but not least, no other comparable other device was retrieved as the active transcutaneous bone conduction hearing device is the only available at the moment.

          Conclusion

          The device’s transcutaneous technology results in a minor event incidence rate of one in 9.9 person-years and a major incidence rate of one in 148.9 person-years. Based on the audiological outcomes, high patient satisfaction as well as the low complication rate, the authors recommend the active transcutaneous bone conduction hearing device as a safe and effective treatment for patients suffering from hearing loss within the device’s indication criteria (conductive and/or mixed hearing loss or single-sided deafness).

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          Most cited references48

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          Matrix product ansatz for Fermi fields in one dimension

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            Assessment of more than 1,000 implanted percutaneous bone conduction devices: skin reactions and implant survival.

            This study assesses soft tissue reactions and implant stability of 1,132 percutaneous titanium implants (970 patients) for bone conduction devices (BCDs). In addition, it examines BCD usage and comparisons between different patient groups.
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              • Article: not found

              First European multicenter results with a new transcutaneous bone conduction hearing implant system: short-term safety and efficacy.

              To investigate safety and efficacy of a new transcutaneous bone conduction hearing implant, over a 3-month follow-up period.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Formal analysisRole: VisualizationRole: Writing – review & editing
                Role: Formal analysisRole: Writing – review & editing
                Role: Formal analysisRole: Writing – review & editing
                Role: ConceptualizationRole: SupervisionRole: ValidationRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                16 September 2019
                2019
                : 14
                : 9
                : e0221484
                Affiliations
                [1 ] University Clinic St. Poelten, Department of Otorhinolaryngology, Head & Neck Surgery, St. Poelten, Austria
                [2 ] Karl Landsteiner Institute of Implantable Hearing Devices, St. Poelten, Austria
                University of Miami School of Medicine, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0003-4936-1424
                Article
                PONE-D-19-09419
                10.1371/journal.pone.0221484
                6746395
                31525208
                0f3d74cf-fa4d-4124-a7cc-5ed66e56f760
                © 2019 Magele et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 8 April 2019
                : 7 August 2019
                Page count
                Figures: 5, Tables: 3, Pages: 19
                Funding
                The authors received no specific funding for this work.
                Categories
                Research Article
                Medicine and Health Sciences
                Otorhinolaryngology
                Otology
                Hearing Disorders
                Deafness
                Biology and Life Sciences
                Bioengineering
                Biotechnology
                Medical Devices and Equipment
                Medical Implants
                Engineering and Technology
                Bioengineering
                Biotechnology
                Medical Devices and Equipment
                Medical Implants
                Medicine and Health Sciences
                Medical Devices and Equipment
                Medical Implants
                Biology and Life Sciences
                Bioengineering
                Biotechnology
                Medical Devices and Equipment
                Engineering and Technology
                Bioengineering
                Biotechnology
                Medical Devices and Equipment
                Medicine and Health Sciences
                Medical Devices and Equipment
                Research and Analysis Methods
                Mathematical and Statistical Techniques
                Statistical Methods
                Metaanalysis
                Physical Sciences
                Mathematics
                Statistics
                Statistical Methods
                Metaanalysis
                Medicine and Health Sciences
                Otorhinolaryngology
                Otology
                Hearing Disorders
                Medicine and Health Sciences
                Otorhinolaryngology
                Otology
                Audiology
                Social Sciences
                Linguistics
                Cognitive Linguistics
                Word Recognition
                Research and Analysis Methods
                Database and Informatics Methods
                Database Searching
                Custom metadata
                All relevant data are within the manuscript and its Supporting Information files.

                Uncategorized
                Uncategorized

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