Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices

Sabine Reinfeldt,1 Cristina Rigato,1 Bo Håkansson,1 Karl-Johan Fredén Jansson,1 Måns Eeg-Olofsson21Department of Electrical Engineering, Chalmers University of Technology, Gothenburg, Sweden; 2Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska Univer...

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Autores principales:	Reinfeldt S, Rigato C, Håkansson B, Fredén Jansson KJ, Eeg-Olofsson M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2019
Materias:	Bone Conduction Nasal sound pressure Bone Conduction Implant Ear-canal sound pressure Objective Intraoperative verification. Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/214fc765c4b04019b1c2a882347697df
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spelling	oai:doaj.org-article:214fc765c4b04019b1c2a882347697df2021-12-02T10:43:41ZNasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices1179-1470https://doaj.org/article/214fc765c4b04019b1c2a882347697df2019-05-01T00:00:00Zhttps://www.dovepress.com/nasal-sound-pressure-as-objective-verification-of-implant-in-active-tr-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Sabine Reinfeldt,1 Cristina Rigato,1 Bo Håkansson,1 Karl-Johan Fredén Jansson,1 Måns Eeg-Olofsson21Department of Electrical Engineering, Chalmers University of Technology, Gothenburg, Sweden; 2Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska University Hospital, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenObjective: Active transcutaneous bone conduction devices consist of an external audio processor and an internal implant under intact skin. During the surgical procedure, it is important to verify the functionality of the implant before the surgical wound is closed. In a clinical study with the new bone conduction implant (BCI), the functionality of the implant was tested with an electric transmission test, where the output was the nasal sound pressure (NSP) recorded in the ipsilateral nostril. The same measurement was performed in all follow-up visits to monitor the implant’s functionality and transmission to bone over time. The objective of this study was to investigate the validity of the NSP method as a tool to objectively verify the implant’s performance intraoperatively, as well as to follow-up the implant’s performance over time.Design: Thirteen patients with the BCI were included, and the NSP measurement was part of the clinical study protocol. The implant was electrically stimulated with an amplitude-modulated signal generator using a swept sine 0.1–10 kHz. The NSP was measured with a probe tube microphone in the ipsilateral nostril.Results: The NSP during surgery was above the noise floor for most patients within the frequency interval 0.4–5 kHz, showing NSP values for expected normal transmission of a functioning implant. Inter-subject comparison showed large variability, but follow-up results showed only minor variability within each subject. Further investigation showed that the NSP was stable over time.Conclusion: The NSP method is considered applicable to verify the implant’s functionality during and after surgery. Such a method is important for implantable devices, but should be simplified and clinically adapted. Large variations between subjects were found, as well as smaller variability in intra-subject comparisons. As the NSP was found to not change significantly over time, stable transmission to bone, and implant functionality, were indicated.Keywords: bone conduction, nasal sound pressure, bone conduction implant, ear-canal sound pressure, objective intraoperative verificationReinfeldt SRigato CHåkansson BFredén Jansson KJEeg-Olofsson MDove Medical PressarticleBone ConductionNasal sound pressureBone Conduction ImplantEar-canal sound pressureObjective Intraoperative verification.Medical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 12, Pp 193-202 (2019)
institution	DOAJ
collection	DOAJ
language	EN
topic	Bone Conduction Nasal sound pressure Bone Conduction Implant Ear-canal sound pressure Objective Intraoperative verification. Medical technology R855-855.5
spellingShingle	Bone Conduction Nasal sound pressure Bone Conduction Implant Ear-canal sound pressure Objective Intraoperative verification. Medical technology R855-855.5 Reinfeldt S Rigato C Håkansson B Fredén Jansson KJ Eeg-Olofsson M Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
description	Sabine Reinfeldt,1 Cristina Rigato,1 Bo Håkansson,1 Karl-Johan Fredén Jansson,1 Måns Eeg-Olofsson21Department of Electrical Engineering, Chalmers University of Technology, Gothenburg, Sweden; 2Department of Otorhinolaryngology, Head and Neck Surgery, Sahlgrenska University Hospital, The Sahlgrenska Academy, University of Gothenburg, Gothenburg, SwedenObjective: Active transcutaneous bone conduction devices consist of an external audio processor and an internal implant under intact skin. During the surgical procedure, it is important to verify the functionality of the implant before the surgical wound is closed. In a clinical study with the new bone conduction implant (BCI), the functionality of the implant was tested with an electric transmission test, where the output was the nasal sound pressure (NSP) recorded in the ipsilateral nostril. The same measurement was performed in all follow-up visits to monitor the implant’s functionality and transmission to bone over time. The objective of this study was to investigate the validity of the NSP method as a tool to objectively verify the implant’s performance intraoperatively, as well as to follow-up the implant’s performance over time.Design: Thirteen patients with the BCI were included, and the NSP measurement was part of the clinical study protocol. The implant was electrically stimulated with an amplitude-modulated signal generator using a swept sine 0.1–10 kHz. The NSP was measured with a probe tube microphone in the ipsilateral nostril.Results: The NSP during surgery was above the noise floor for most patients within the frequency interval 0.4–5 kHz, showing NSP values for expected normal transmission of a functioning implant. Inter-subject comparison showed large variability, but follow-up results showed only minor variability within each subject. Further investigation showed that the NSP was stable over time.Conclusion: The NSP method is considered applicable to verify the implant’s functionality during and after surgery. Such a method is important for implantable devices, but should be simplified and clinically adapted. Large variations between subjects were found, as well as smaller variability in intra-subject comparisons. As the NSP was found to not change significantly over time, stable transmission to bone, and implant functionality, were indicated.Keywords: bone conduction, nasal sound pressure, bone conduction implant, ear-canal sound pressure, objective intraoperative verification
format	article
author	Reinfeldt S Rigato C Håkansson B Fredén Jansson KJ Eeg-Olofsson M
author_facet	Reinfeldt S Rigato C Håkansson B Fredén Jansson KJ Eeg-Olofsson M
author_sort	Reinfeldt S
title	Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
title_short	Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
title_full	Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
title_fullStr	Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
title_full_unstemmed	Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
title_sort	nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
publisher	Dove Medical Press
publishDate	2019
url	https://doaj.org/article/214fc765c4b04019b1c2a882347697df
work_keys_str_mv	AT reinfeldts nasalsoundpressureasobjectiveverificationofimplantinactivetranscutaneousboneconductiondevices AT rigatoc nasalsoundpressureasobjectiveverificationofimplantinactivetranscutaneousboneconductiondevices AT hakanssonb nasalsoundpressureasobjectiveverificationofimplantinactivetranscutaneousboneconductiondevices AT fredenjanssonkj nasalsoundpressureasobjectiveverificationofimplantinactivetranscutaneousboneconductiondevices AT eegolofssonm nasalsoundpressureasobjectiveverificationofimplantinactivetranscutaneousboneconductiondevices
_version_	1718396813307805696

Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices

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