Active transcutaneous bone conduction hearing implants: Systematic review and meta-analysis
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...
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| Published in | PloS one Vol. 14; no. 9; p. e0221484 |
|---|---|
| Main Authors | , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Public Library of Science
16.09.2019
Public Library of Science (PLoS) |
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| Online Access | Get full text |
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| Abstract | 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.
To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.
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.
Randomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.
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.
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.
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.
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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| AbstractList | 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.
To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.
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.
Randomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.
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.
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.
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.
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). 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). 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. To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device. 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. 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. 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). 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). 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.BACKGROUNDIn 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.To critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.OBJECTIVESTo critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.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.DATA SOURCESLiterature 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.Randomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.STUDY ELIGIBILITY CRITERIARandomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.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.STUDY APPRAISAL AND SYNTHESIS METHODSRetrieved 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.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.RESULTS39 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.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.LIMITATIONSA 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.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).CONCLUSIONThe 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). BackgroundIn 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.ObjectivesTo critically assess the current literature on safety, efficacy and subjective benefit after implantation with an active transcutaneous bone conduction hearing device.Data sourcesLiterature 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 criteriaRandomized controlled trials, clinical controlled trials and cohort studies, case series and case reports investigating subjective and objective outcomes.Study appraisal and synthesis methodsRetrieved 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.Results39 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.LimitationsA 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.ConclusionThe 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). |
| Audience | Academic |
| Author | Sprinzl, Georg Mathias Magele, Astrid Schoerg, Philipp Stanek, Barbara Gradl, Bernhard |
| AuthorAffiliation | 1 University Clinic St. Poelten, Department of Otorhinolaryngology, Head & Neck Surgery, St. Poelten, Austria University of Miami School of Medicine, UNITED STATES 2 Karl Landsteiner Institute of Implantable Hearing Devices, St. Poelten, Austria |
| AuthorAffiliation_xml | – name: 1 University Clinic St. Poelten, Department of Otorhinolaryngology, Head & Neck Surgery, St. Poelten, Austria – name: 2 Karl Landsteiner Institute of Implantable Hearing Devices, St. Poelten, Austria – name: University of Miami School of Medicine, UNITED STATES |
| Author_xml | – sequence: 1 givenname: Astrid surname: Magele fullname: Magele, Astrid – sequence: 2 givenname: Philipp surname: Schoerg fullname: Schoerg, Philipp – sequence: 3 givenname: Barbara surname: Stanek fullname: Stanek, Barbara – sequence: 4 givenname: Bernhard surname: Gradl fullname: Gradl, Bernhard – sequence: 5 givenname: Georg Mathias orcidid: 0000-0003-4936-1424 surname: Sprinzl fullname: Sprinzl, Georg Mathias |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/31525208$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | COPYRIGHT 2019 Public Library of Science 2019 Magele et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. 2019 Magele et al 2019 Magele et al |
| Copyright_xml | – notice: COPYRIGHT 2019 Public Library of Science – notice: 2019 Magele et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. – notice: 2019 Magele et al 2019 Magele et al |
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| DOI | 10.1371/journal.pone.0221484 |
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| Snippet | 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... Background In July 2018 the active transcutaneous bone conduction hearing implant received FDA approval in the US (for patients 12 years and older with... BackgroundIn July 2018 the active transcutaneous bone conduction hearing implant received FDA approval in the US (for patients 12 years and older with... Background In July 2018 the active transcutaneous bone conduction hearing implant received FDA approval in the US (for patients 12 years and older with... |
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| SubjectTerms | Biology and Life Sciences Bone Conduction Bone implants Case reports Clinical trials Cochlear Implants - adverse effects Cochlear Implants - psychology Complications Conduction Conductivity Deafness Engineering and Technology Evaluation Hearing aids Hearing loss Humans Implantation Incidence Integer programming Landsteiner, Karl Language Localization Medical equipment Medical research Medicine and Health Sciences Meta-analysis Noise Online searching Otolaryngology Otology Patient Satisfaction Patients Pattern recognition Pediatrics Physical Sciences Randomized Controlled Trials as Topic Recognition Research and Analysis Methods Safety and security measures Sensitivity analysis Skin Social Sciences Stability analysis Studies Subgroups Surgery Systematic review Technology Transplants & implants Words (language) |
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| Title | Active transcutaneous bone conduction hearing implants: Systematic review and meta-analysis |
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