Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice

Study design and methods for a multi-centre longitudinal observational study

Deborah Vickers, Angela Canas, Aneeka Degun, John Briggs, Mina Bingham, Joseph Toner, Huw Cooper, Sarah Rogers, Stacey Cooper, Richard Irving, Patrick Spielman, Samantha Batty, Stephen Jones, Abi Asher, Mark Chung, Neil Donnelly, Anna Skibinska, Robert Gardner, Chris Raine, Rachel Andrew & 10 others Kevin Green, Hashmat Ghulam, Terry Nunn, Dan Jiang, Severin Fürhapter, Michael Urban, Kate Hanvey, Sarah Flynn, David Lovegrove, Shakeel Saeed

Research output: Contribution to journalArticle

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Abstract

Background: The Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance.

Method: The study was designed based on a combination of a literature search, two clinician focus groups and expert review. A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise.

Conclusion: This is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications.
Original languageEnglish
Pages (from-to)137 - 140
Number of pages4
JournalContemporary Clinical Trials Communications
Volume10
Early online date15 Mar 2018
DOIs
Publication statusPublished - Jun 2018

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Observational Studies
Longitudinal Studies
Quality of Life
Equipment and Supplies
Hearing
Ossicular Prosthesis
Research
Skin
Speech Perception
Focus Groups
Transducers
Radio
Noise
Bone and Bones
Infection
Clinical Studies
Surveys and Questionnaires

Keywords

  • Bone conducting device
  • Bonebridge
  • Soundbridge
  • Middle ear implant
  • Implant registry
  • Quality of life

Cite this

Vickers, Deborah ; Canas, Angela ; Degun, Aneeka ; Briggs, John ; Bingham, Mina ; Toner, Joseph ; Cooper, Huw ; Rogers, Sarah ; Cooper, Stacey ; Irving, Richard ; Spielman, Patrick ; Batty, Samantha ; Jones, Stephen ; Asher, Abi ; Chung, Mark ; Donnelly, Neil ; Skibinska, Anna ; Gardner, Robert ; Raine, Chris ; Andrew, Rachel ; Green, Kevin ; Ghulam, Hashmat ; Nunn, Terry ; Jiang, Dan ; Fürhapter, Severin ; Urban, Michael ; Hanvey, Kate ; Flynn, Sarah ; Lovegrove, David ; Saeed, Shakeel. / Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice : Study design and methods for a multi-centre longitudinal observational study. In: Contemporary Clinical Trials Communications. 2018 ; Vol. 10. pp. 137 - 140.
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abstract = "Background: The Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance.Method: The study was designed based on a combination of a literature search, two clinician focus groups and expert review. A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise.Conclusion: This is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications.",
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author = "Deborah Vickers and Angela Canas and Aneeka Degun and John Briggs and Mina Bingham and Joseph Toner and Huw Cooper and Sarah Rogers and Stacey Cooper and Richard Irving and Patrick Spielman and Samantha Batty and Stephen Jones and Abi Asher and Mark Chung and Neil Donnelly and Anna Skibinska and Robert Gardner and Chris Raine and Rachel Andrew and Kevin Green and Hashmat Ghulam and Terry Nunn and Dan Jiang and Severin F{\"u}rhapter and Michael Urban and Kate Hanvey and Sarah Flynn and David Lovegrove and Shakeel Saeed",
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Vickers, D, Canas, A, Degun, A, Briggs, J, Bingham, M, Toner, J, Cooper, H, Rogers, S, Cooper, S, Irving, R, Spielman, P, Batty, S, Jones, S, Asher, A, Chung, M, Donnelly, N, Skibinska, A, Gardner, R, Raine, C, Andrew, R, Green, K, Ghulam, H, Nunn, T, Jiang, D, Fürhapter, S, Urban, M, Hanvey, K, Flynn, S, Lovegrove, D & Saeed, S 2018, 'Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice: Study design and methods for a multi-centre longitudinal observational study', Contemporary Clinical Trials Communications, vol. 10, pp. 137 - 140. https://doi.org/10.1016/j.conctc.2018.03.007

Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice : Study design and methods for a multi-centre longitudinal observational study. / Vickers, Deborah; Canas, Angela; Degun, Aneeka; Briggs, John; Bingham, Mina; Toner, Joseph; Cooper, Huw; Rogers, Sarah; Cooper, Stacey; Irving, Richard; Spielman, Patrick; Batty, Samantha; Jones, Stephen; Asher, Abi; Chung, Mark; Donnelly, Neil; Skibinska, Anna; Gardner, Robert; Raine, Chris; Andrew, Rachel; Green, Kevin; Ghulam, Hashmat; Nunn, Terry; Jiang, Dan; Fürhapter, Severin; Urban, Michael; Hanvey, Kate; Flynn, Sarah; Lovegrove, David; Saeed, Shakeel.

In: Contemporary Clinical Trials Communications, Vol. 10, 06.2018, p. 137 - 140.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Evaluating the effectiveness and reliability of the Vibrant Soundbridge and Bonebridge auditory implants in clinical practice

T2 - Study design and methods for a multi-centre longitudinal observational study

AU - Vickers, Deborah

AU - Canas, Angela

AU - Degun, Aneeka

AU - Briggs, John

AU - Bingham, Mina

AU - Toner, Joseph

AU - Cooper, Huw

AU - Rogers, Sarah

AU - Cooper, Stacey

AU - Irving, Richard

AU - Spielman, Patrick

AU - Batty, Samantha

AU - Jones, Stephen

AU - Asher, Abi

AU - Chung, Mark

AU - Donnelly, Neil

AU - Skibinska, Anna

AU - Gardner, Robert

AU - Raine, Chris

AU - Andrew, Rachel

AU - Green, Kevin

AU - Ghulam, Hashmat

AU - Nunn, Terry

AU - Jiang, Dan

AU - Fürhapter, Severin

AU - Urban, Michael

AU - Hanvey, Kate

AU - Flynn, Sarah

AU - Lovegrove, David

AU - Saeed, Shakeel

PY - 2018/6

Y1 - 2018/6

N2 - Background: The Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance.Method: The study was designed based on a combination of a literature search, two clinician focus groups and expert review. A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise.Conclusion: This is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications.

AB - Background: The Vibrant Soundbridge middle ear implant and the Bonebridge bone conducting hearing device are hearing implants that use radio frequency transmission to send information from the sound processor to the internal transducer. This reduces the risk of skin problems and infection but requires a more involved surgical procedure than competitor skin penetrating devices. It is not known whether more complex surgery will lead to additional complications. There is little information available on the reliability of these systems and adverse medical or surgical events. The primary research question is to determine the reliability and complication rate for the Vibrant Soundbridge and Bonebridge. The secondary research question explores changes in quality of life following implantation of the devices. The tertiary research question looks at effectiveness via changes in auditory performance.Method: The study was designed based on a combination of a literature search, two clinician focus groups and expert review. A multi-centre longitudinal observational study was designed. There are three study groups, two will have been implanted prior to the start of the study and one group, the prospective group, will be implanted after initiation of the study. Outcomes are surgical questionnaires, measures of quality of life, user satisfaction and speech perception tests in quiet and in noise.Conclusion: This is the first multi-centre study to look at these interventions and includes follow up over time to understand effectiveness, reliability, quality of life and complications.

KW - Bone conducting device

KW - Bonebridge

KW - Soundbridge

KW - Middle ear implant

KW - Implant registry

KW - Quality of life

U2 - 10.1016/j.conctc.2018.03.007

DO - 10.1016/j.conctc.2018.03.007

M3 - Article

VL - 10

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JO - Contemporary Clinical Trials Communications

JF - Contemporary Clinical Trials Communications

SN - 2451-8654

ER -