Interview with Deborah Arthur Audiologist, and Vice President of Clinical and Regulatory Affairs, Symphonix

AO/Beck: Hi Deb. Thanks for joining me. Before we jump into the Myths and Reality issues associated with Middle Ear Implants, we ought to spend a few moments telling the readers who you are!

Arthur: Sure Doug. I am the Vice President of Clinical and Regulatory Affairs at Symphonix. I am an audiologist and I've been involved with Middle Ear Implants (MEIs) for over 10 years.

AO/Beck: We also ought to clarify that Middle Ear Implants (MEIs) are actually not a new technology. In fact, I recall reading that research started on MEIs more than 50 years ago and in various forms of development, they have been used in the USA for almost 20 years.

Arthur: Yes, that's correct. Clinical research has been active in this area since the 1980's. The Symphonix Soundbridge was approved by the FDA about 18 months ago but that occurred after a rigorous, controlled clinical trial (1996-00) at ten implanting centers across the USA.

AO/Beck: Deb, I think many people associate MEIs with conductive, or middle ear hearing loss. At this point, it seems to me that the patients with conductive losses are not the primary candidates any longer. Is that correct?

Arthur: Doug, the current middle ear implantable hearing devices are active. They don't replace parts of the ossicular chain, rather they augment the natural motion of the bones in the middle ear to enhance the signal reaching the impaired inner ear. The Symphonix Vibrant Soundbridge is for patients with moderate to severe sensorineural hearing loss, also called a nerve loss.

AO/Beck: One issue patients bring up now and then is If the solution is surgical, the problem must be worse than I thought! Can you address that please?

Arthur: The Vibrant Soundbridge is indeed a surgically implanted device, but the idea that surgical solutions indicate a worse problem is ill-founded. The fact that there are surgical solutions for common types of hearing loss may actually indicate that we are advancing with regards to how to integrate knowledge about hearing loss, digital hearing instruments, and implant technology to provide more alternatives for common hearing loss problems.

AO/Beck: Another issue is the use of the term digital as it applies to MEIs. What is the advantage of a digital MEI system?

Arthur: Digital signal processing allows the audiologist more flexibility in programming the middle ear implant to best meet the individual hearing needs of each patient. Additionally, digital programming allows the instrument to be reprogrammed in the future, should their hearing needs change.

AO/Beck: How many patients have been implanted with the Vibrant Soundbridge?

Arthur: The current numbers indicate there are almost 800 users worldwide.


AO/Beck: Is the Vibrant Soundbridge intended for bilateral (both ear) implantation?

Arthur: The Soundbridge was FDA approved based on monaural (single ear) implantation. Some patients have requested, and some physicians and audiologists have recommended bilateral devices. Since FDA approval in the USA (in August 2000) about 10 to 15 percent of the patients have opted for bilateral implantation.

AO/Beck: Is the Vibrant Soundbridge just for patients dissatisfied with traditional hearing aids?

Arthur: Good question! Early in the clinical trial with the Soundbridge, we were only looking for patients with expressed problems - occlusion, feedback and external ear comfort/disorder issues. What we learned, was that in addition to those obvious potential patients, other patients who regularly returned to their audiologist looking for better hearing solutions, such as better sound quality, improved clarity, less maintenance and improved comfort - were interested in the Vibrant Soundbridge too.

AO/Beck: I understand the average price for the device and procedure is about $15,000, How do most people pay for this device?

Arthur: There are actually two answers to this question. The first is private pay, or self-pay. That is, the patient simply pays for the related costs. The payment is sometimes a check or credit card, and sometimes the patients finance the expense. Many professional offices have the ability to set-up patients with financing programs. Of course, the second option is their health insurance. We always recommend that patients work with their physician to see if the middle ear implant can be pre-approved by their insurance company. We have been more successful with this over the past few months and I think this will greatly improve access to middle ear implants for many patients.

AO/Beck: Deb, thanks for your time and thanks for clarifying these issues. For the readers interested in learning more about MEIs, do they just click into your website?

Arthur: Yes, Doug, that's probably the best place to start. They can visit us at www.symphonix.com, or they can dial the toll free number too. We're available at 1-800-833-7733.

AO/Beck: Thanks Deb. It's a pleasure speaking with you.