Robustness and lifetime of the bone conduction implant – a pilot study
Karl-Johan Fredén Jansson,1 Bo Håkansson,1 Cristina Rigato,1 Måns Eeg-Olofsson,2 Sabine Reinfeldt1 1Department of Electrical Engineering, Chalmers University of Technology, Göteborg, Sweden; 2Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrensk...
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Dove Medical Press
2019
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oai:doaj.org-article:812ae94d80664f3ea3b1f5ec1b120b4d2021-12-02T02:26:25ZRobustness and lifetime of the bone conduction implant – a pilot study1179-1470https://doaj.org/article/812ae94d80664f3ea3b1f5ec1b120b4d2019-02-01T00:00:00Zhttps://www.dovepress.com/robustness-and-lifetime-of-the-bone-conduction-implant-a-pilot-study-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Karl-Johan Fredén Jansson,1 Bo Håkansson,1 Cristina Rigato,1 Måns Eeg-Olofsson,2 Sabine Reinfeldt1 1Department of Electrical Engineering, Chalmers University of Technology, Göteborg, Sweden; 2Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Objectives: The objective of this study was to develop methods for evaluating the mechanical robustness and estimating the lifetime of the novel bone conduction implant (BCI) that is used in a clinical study. The methods are intended to be applicable to any similar device.Materials and methods: The robustness was evaluated using tests originally developed for cochlear implants comprising a random vibration test, a shock test, a pendulum test, and an impact test. Furthermore, magnetically induced torque and demagnetization during magnetic resonance imaging at 1.5 T were investigated using a dipole electromagnet. To estimate the lifetime of the implant, a long-term age-accelerated test was performed.Results: Out of all the tests, the pendulum and the impact tests had the largest effect on the electro-acoustic performance of the BCI implant, even if the change in performance was within acceptable limits (<20%). In comparison with baseline data, the lower and higher resonance peaks shifted down in frequency by 13% and 18%, respectively, and with a loss in magnitude of 1.1 and 2.0 dB, respectively, in these tests.Conclusion: A complete series of tests were developed, and the BCI passed all the tests; its lifetime was estimated to be at least 26 years for patients who are using the implant for 12 hours on a daily basis. Keywords: audiology, bone conduction audiometry, electromagnetic transducer, electro-acousticsFredén Jansson KJHåkansson BRigato CEeg-Olofsson MReinfeldt SDove Medical PressarticleAudiologyBone Conduction AudiometryElectromagnetic TransducerElectro-AcousticsMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 12, Pp 89-100 (2019) |
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Audiology Bone Conduction Audiometry Electromagnetic Transducer Electro-Acoustics Medical technology R855-855.5 |
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Audiology Bone Conduction Audiometry Electromagnetic Transducer Electro-Acoustics Medical technology R855-855.5 Fredén Jansson KJ Håkansson B Rigato C Eeg-Olofsson M Reinfeldt S Robustness and lifetime of the bone conduction implant – a pilot study |
description |
Karl-Johan Fredén Jansson,1 Bo Håkansson,1 Cristina Rigato,1 Måns Eeg-Olofsson,2 Sabine Reinfeldt1 1Department of Electrical Engineering, Chalmers University of Technology, Göteborg, Sweden; 2Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden Objectives: The objective of this study was to develop methods for evaluating the mechanical robustness and estimating the lifetime of the novel bone conduction implant (BCI) that is used in a clinical study. The methods are intended to be applicable to any similar device.Materials and methods: The robustness was evaluated using tests originally developed for cochlear implants comprising a random vibration test, a shock test, a pendulum test, and an impact test. Furthermore, magnetically induced torque and demagnetization during magnetic resonance imaging at 1.5 T were investigated using a dipole electromagnet. To estimate the lifetime of the implant, a long-term age-accelerated test was performed.Results: Out of all the tests, the pendulum and the impact tests had the largest effect on the electro-acoustic performance of the BCI implant, even if the change in performance was within acceptable limits (<20%). In comparison with baseline data, the lower and higher resonance peaks shifted down in frequency by 13% and 18%, respectively, and with a loss in magnitude of 1.1 and 2.0 dB, respectively, in these tests.Conclusion: A complete series of tests were developed, and the BCI passed all the tests; its lifetime was estimated to be at least 26 years for patients who are using the implant for 12 hours on a daily basis. Keywords: audiology, bone conduction audiometry, electromagnetic transducer, electro-acoustics |
format |
article |
author |
Fredén Jansson KJ Håkansson B Rigato C Eeg-Olofsson M Reinfeldt S |
author_facet |
Fredén Jansson KJ Håkansson B Rigato C Eeg-Olofsson M Reinfeldt S |
author_sort |
Fredén Jansson KJ |
title |
Robustness and lifetime of the bone conduction implant – a pilot study |
title_short |
Robustness and lifetime of the bone conduction implant – a pilot study |
title_full |
Robustness and lifetime of the bone conduction implant – a pilot study |
title_fullStr |
Robustness and lifetime of the bone conduction implant – a pilot study |
title_full_unstemmed |
Robustness and lifetime of the bone conduction implant – a pilot study |
title_sort |
robustness and lifetime of the bone conduction implant – a pilot study |
publisher |
Dove Medical Press |
publishDate |
2019 |
url |
https://doaj.org/article/812ae94d80664f3ea3b1f5ec1b120b4d |
work_keys_str_mv |
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_version_ |
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