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

Abstract

BackgroundThe 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.MethodThe 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.ConclusionThis 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.

Patient-Reported Outcomes in Middle Ear and Active Transcutaneous Bone Conduction Hearing Implants

“…It is less widely used but has previously been used in a number of studies for examining VSB and BB satisfaction. [1][2][3][4][5][6][7][8] Patient responses may be "very satisfied," "satisfied," "sometimes satisfied/ dissatisfied," "dissatisfied," "very dissatisfied," or "does not apply." The HDSS questionnaire has not been validated, but its questions are particularly suited to implants such as those under investigation.…”

“…It is less widely used but has previously been used in a number of studies for examining VSB and BB satisfaction. 1 - 8 Patient responses may be “very satisfied,” “satisfied,” “sometimes satisfied/dissatisfied,” “dissatisfied,” “very dissatisfied,” or “does not apply.” The HDSS questionnaire has not been validated, but its questions are particularly suited to implants such as those under investigation. The authors were unable to retrieve any instructions on questionnaire administration or analysis in the published articles identified above.…”

Cartilage Conduction Hearing and Its Clinical Application

“…The fixation of the transducer can cause poor esthetics. Surgical procedures, such as implanting bone-anchored hearing aids (BAHAs), are additional options [ 25 , 26 , 27 , 28 , 29 , 30 , 31 ] but involve various risks, such as adverse medical and surgical events, infection, and follow-up surgery [ 32 , 33 ]. Some patients also refuse BAHA implantation because of cosmetic considerations [ 34 ].…”

Medical Safety and Device Reliability of Active Transcutaneous Middle Ear and Bone Conducting Implants: A Long-Term Multi-Centre Observational Study

“…The focus groups were comprised of surgical and audiological representatives from the contributing clinical sites. The full study design and development of this research protocol were reported by Vickers et al [6].…”