Volume 2, Chapter 04: The Active Middle Ear Implant VIBRANT SOUNDBRIDGE: Outcomes on Safety, Efficacy, Effectiveness and Subjective Benefit 1996-2017

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Last Updated on Tuesday, 17 December 2019 15:11

Written by Michael Urban Dr., MBA, Francesca Scandurra PhD, Anna Truntschnig MS, Severin Fuerhapter PhD & Geoffrey Ball

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Summary

Since 2001, the World Health Organisation (WHO) has included adult-onset hearing loss in the tables of global burden of disease in the World Health Report. Hearing loss has become a major global health issue, affecting about 15 % of the world’s adult population. In 2015, approximately half a billion of people (~6.8 % of the world’s population) suffered from disabling hearing loss (moderate, severe and profound degree of hearing loss, defined in Table 1) (Wilson et al., 2017). If left untreated, this unaddressed hearing loss (greater than 35 dB in the better-hearing ear) poses an annual cost in the range of $750-$790 billion globally (WHO, 2017b). It has to be noted, that these estimates do not include other expenses, such as hospital outpatient visits, sign language interpreters and family out-of-pocket expenses. Therefore the actual economic costs of hearing loss will be even higher than what is reported here. (Grosse 2007 in WHO, 2017a).

There are different types of hearing loss including sensorineural, mixed and conductive hearing losses. People with hearing loss can benefit from medical hearing devices, such as hearing aids, cochlear implants, middle ear implants, active bone conduction implants and other assistive devices. These devices represent cost-effective strategies in treating hearing loss (Wilson et al., 2017). However, the current production of hearing devices meets less than 10% of the global need and estimates indicate that about 72 million (untreated) people with hearing loss could potentially benefit from the use of a hearing device (WHO, 2017a). Hearing implants can be a solution when conventional hearing aids no longer give enough benefit. Implant systems can also be an option for individuals who are not satisfied with conventional hearing aids. They are designed for different types of hearing loss and are surgically implanted electronic devices, which can give individuals the sensation of sound.

As a clear drawback regarding published evidence, when analysing literature on hearing implants in general, one can observe quite poor reporting of sample and/or methods, unrepresentative samples, sample size being equal to or less than 5 subjects, incomparable outcome measures, no or poor reporting of outcome data, e.g., data being collapsed across study groups or implant types. In some of these cases no definite conclusions can be drawn. Due to the lack of comparative studies, no binding statement can be made on which kind of implant is better or worse than another. They all have their pros and cons.

This being a chapter on the outcomes on safety, efficacy/effectiveness and subjective benefit of the VIBRANT SOUNDBRIDGE (VSB), only the middle ear implant “VIBRANT SOUNDBRIDGE” and the Vibroplasty Couplers will be discussed. As demonstrated in the literature, the VSB offers a safe and effective alternative for patients with various middle ear pathologies. This new strategy in hearing rehabilitation has led to an improved quality of hearing and life. Besides the functional gain, speech perception in quiet and noise is a major tool to evaluate the functionality and dynamic range of a hearing implant. Yet the more publications refer to the same topic the more apparent it becomes regarding the variety of testing tools that are available. It is only possible to say that in general, test scores improved with the VSB. The most compact group that could be discussed applied the ‘Freiburger Sprachtest’ at 65 dB. In this setting the VSB leads to an improvement of speech understanding of about 41 % in sensorineural hearing loss (SNHL), 55.5 % in mixed hearing loss (MHL) and 78.1 % in pure conductive hearing loss (CHL), respectively.

Data collected on speech perception in noise reflects even more heterogeneity in methods. It is only possible to say that in general test scores improved with the VSB. Patient satisfaction and performance with the SOUNDBRIDGE have been high and consistent across centres, countries and continents, evidenced by the data and reports in numerous publications and presentations. In general, patients who wear the device all day long (up to about 16 hours, some patients even sleep with it on), report a natural sound quality, high device satisfaction, and a better ability to understand especially in noisy environments (Luetje et al., 2002). Again the number of available testing tools outweighs the results; the most frequent ones being the Abbreviated Profile of Hearing Aid Benefit APHAB and the Glasgow Benefit Inventory (GBI). In all studies reporting on subjective outcomes patients benefit from a VSB (and hearing aids, either in addition or compared to), but there are major differences within the subscales (background noise, reverberation, ease of communication, aversiveness to sound). In general the VSB is described as much more comfortable, clearer in sound perception and less events of unease are reported.

In conclusion the VSB can be a safe tool in surgically experienced hands. As there are no standard operating procedures to compare functional outcomes or measure subjective qualities of device performance the data measured are rarely comparable. Nonetheless the VSB turns out to be a highly reliable device that significantly improves perception of speech in noisy situations with a high sound quality. The applications of the VSB in mixed and conductive hearing loss have widened the therapeutic spectrum to improve hearing in those patients who could not be treated effectively enough as yet. Adverse events are below the range for conventional ME surgery and bone conduction hearing implantation; and the audiological outcomes demonstrate a long-term effectiveness. As shown very recently by Kosaner Kliess and colleagues (Kosaner Kliess et al., 2017), it is also a very cost-effective solution in terms of costs (measured as incremental cost-utility ratio (ICUR)) of AUD 9,913.72 per QALY being below a willingness-to-pay threshold of AUD 34,500 in the Australian healthcare setting

Multimedia

Link 1: How the SOUNDBRIDGE Works (English) - https://youtu.be/khvrHgSFl_8

Link 2: VSB implantation: https://medel.webgate.media/en/directlink/ae19966676143c21/133269

Link 3: Key Features Video SOUNDBRIDGE - 503 and Couplers: https://youtu.be/gzpNY6Rk-Hc

Link 4: 20 yrs VSB Users Video ( English) - https://youtu.be/KUhTWV397pE

Link 5: 20 yrs VSB Professional Video (English) - https://youtu.be/YVWY0D3zq3w

Link 6: 20 yrs VSB Lenarz und Frau Nacke Video (English subtitles) - https://youtu.be/24oBiS6avQo

Link 7: Daniel VSB Testimonial https://youtu.be/me4VMw49rhE

Chapter Contributors

Michael Urban Dr. rer. nat.,MBA, MS

Michael is a Group Leader Technology Assessment at MED-EL Hearing Technology GmbH, BU Vibrant and a member of ISPOR and HTAi. He is based in Innsbruck, Austria. Michael received his degree in Chemistry at the LMU Munich. After working in the bioanalytics field for several years, further education led him to an MBA in General Management at the Management Center Innsbruck and an MSc in Pharmacoeconomics and Health Economics at the UPF Barcelona School of Management. Since 2012 he is responsible for the reimbursement of Middle Ear and Bone Conduction Implants within the family of MED-EL’s implantable solutions. Based on his in-depth experience in clinical epidemiology, EBM, health economics and public health, Michael focusses on planning, developing, reporting results of systematic literature reviews, value dossiers or brochures and communicating these outcomes to all kinds of stakeholders. He has managed several peer reviewed publications as well as submissions to reimbursement and HTA authorities worldwide. He can be reached at: This email address is being protected from spambots. You need JavaScript enabled to view it.

Severin Fürhapter PhD

Severin Fürhapter holds a Master’s degree in Physics obtained at the University of Innsbruck and a PhD in Medical Sciences from the Innsbruck Medical University. During this time, he published 11 peer reviewed articles (3 of them as a first author). He has worked for MED-EL, Business Unit Vibrant since May 2008 and since October 2013 he is Head of Hearing Science and Clinical Research at MED-EL, Business Unit Vibrant. Dr. Fürhapter can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it.

Anna Truntschnig, MSc

Anna Truntschnig, studied at the Erasmus University Rotterdam, Università di Bologna, University of Oslo and Management Center Innsbruck, where she successfully completed the European Master in Health Economics and Management. In 2016 she implemented a database for a malnutrition project of the Health Foundation Nepal in Saudiyar, Dang as data analyst. Since 2017, she works as Technology Assessment Associate at the Business Unit Vibrant, MED-EL in Innsbruck, Austria. She can be reached at: This email address is being protected from spambots. You need JavaScript enabled to view it.

Francesca M. Scandurra PhD

Francesca M. Scandurra earned a degree in molecular biology (July 2003) and a European PhD in Biochemistry (March 2007) contributing on the field of structure-function of metallo-proteins and Nitric Oxide. She worked successfully 2 years as Post-Doc at the Medical University of Innsbruck and at the OROBOROS GmbH searching on mitochondrial respiration (2007-2009). At BIOCRATES Life Sciences (2009 until 2012), she was analyzing and interpreting metabolomics data as part of the Contract Research team. In April 2012 she joined the HTA team in BU Vibrant MED-EL as scientific publication specialist. She can be reached at: This email address is being protected from spambots. You need JavaScript enabled to view it.

Geoffrey Ball MS

Geoffrey R. Ball is originally a native of Silicon Valley California. He holds a Masters of Science degree from University of Southern California and Bachelors of Science degree from the University of Oregon. He worked at Stanford University and was the director of the Hearing Science lab under Dr. Richard L. Goode for nine years. He founded Symphonix Devices, Inc. in San Jose California in 1994 where he served as Vice President, CTO, Founder and director from 1994 through 2003. Since 20013 Mr. Ball has been the CTO and now Business Unit Director for the Vibrant Division of Med-El in Innsbruck Austria. He has over a hundred patent filings for 23 separate invention categories mostly related to the field of hearing devices. Mr. Ball was implanted with a the Vibrant Soundbridge in 1997 a product he invented in 1992 to treat his deafness and is the only known person to have developed technology to heal a major health issue. Mr. Ball also published a book that he considers a “technology adventure story” based on his own experiences with deafness, academics and business. Mr. Ball also founded the medical field now known as Vibroplasty. He also works to advocate access to and rights to  hearing treatments for the deaf community. He can be reached at: This email address is being protected from spambots. You need JavaScript enabled to view it.

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