Interview with Deborah Arthur M.A., F-AAA, Gary Saxton and Kirk Davis Symphonix Devices, Inc.
Deborah Arthur M.A., F-AAA
Vice President of Clinical Affairs
Symphonix Devices, Inc.
Gary Saxton
Vice President, Sales and Marketing
Symphonix Devices, Inc.
Kirk Davis
President and CEO
Symphonix Devices, Inc.
Beck/AO : Thanks for joining us tonight and congratulations on the recent FDA approval of the Vibrant Soundbridge. I'd like to start by learning a little about the company and then we'll get into the recent pre-market approval (PMA) by the FDA and the commercial launch of the Vibrant Soundbridge.
Symphonix: Well, the company was started in 1994. Geoff Ball, who has had sensorineural hearing loss since childhood, developed the core technology behind the Vibrant Soundbridge while a research engineer at Stanford. He then co-founded Symphonix and has been active in the company ever since that time. He was also one of the first patients to receive the device. Earlier this month, Geoff underwent surgery on his contralateral ear. Symphonix itself is located in San Jose, California and is a public company listed on the NASDAQ. We have our European headquarters in Basel, Switzerland. We have about 85 implanting centers in the U.S., Europe, South America and Canada, and have implanted over 400 patients to-date.
Beck/AO: Who are the ideal candidates for the Vibrant Soundbridge?
Symphonix: The initial indications are for adults, 18 years or older, with a moderate to severe, sensorineural hearing loss who are seeking an alternative to an acoustic hearing aid. We recommend that patients have experience with appropriately fit hearing aids prior to receiving the device.
Beck/AO: According to the paperwork I've seen, when Symphonix says 'severe', you're not talking about people with a 71 to 90 dB loss are you?
Symphonix: No.. it's based on a frequency-by-frequency description. In essence, our device fits hearing losses from between 30 to 65 dB at 500 Hz sloping to 50 to 85 dB at 4000 Hz.
Beck/AO: So the Vibrant Soundbridge is only for people with sensorineural loss, not conductive or mixed losses?
Symphonix: Correct. When some people think about middle ear implants, they may confuse the Vibrant Soundbridge with previous devices which were designed to overcome mixed or conductive losses, such as the Xomed Audiant. The Vibrant Soundbridge is only intended for adults with a moderate to severe sensorineural hearing loss.
Beck/AO: Tell us about the implanted hardware please.
Symphonix: The implanted receiver is called the Vibrating Ossicular Prosthesis (VORP). The body of the VORP resembles the receiver portion of a cochlear implant with a conductor link connecting it to the core technology of the device, the Floating Mass Transducer® (FMT). The conductor link is essentially threaded through a facial recess into the middle ear space where it is attached to the incus via a titanium attachment clip. The VORP is implanted in the mastoid as in cochlear implants. The external portion of the system is called the Audio Processor. The implanted VORP and the external Audio Processor have magnets which couple them across the skin.
Beck/AO: How is the transducer attached to the incus?
Symphonix: The transducer is attached to the incus with a titanium clip. It is attached to the ossicular chain in much the same way as a stapes prosthesis is clamped to the ossicular chain. The clip has the Floating Mass Transducer (FMT) attached to it. A special microsurgical instrument, the 'forming forcep', is specifically designed to not over tighten the clip on the incus. The FMT itself is a titanium can containing a rare earth magnet suspended by two 'spings' and surrounded by the gold wire from the conductor link . The signal from the conductor link induces an electromagnetic field withing the titanium can setting the magnet into motion results in a vibratory motion which is transmitted to the ossicular chain..
Beck/AO: So the VORP is essentially hardwired to the FMT?
Symphonix: Yes, it's all one piece.
Beck/AO: And the connection between the internal and the external units is achieved via magnetic induction?
Symphonix: Yes, that's correct.
Beck/AO: Do the magnets come in variable strengths, as they do in cochlear implants?
Symphonix: Yes, the Audio Processor presently has three magnet strengths.
Beck/AO: I've read a little bit about the processor and I know it's evolved a bit over time. Is the processor using the Siemens Signia?
Symphonix: The external Audio Processor has undergone some changes since the beginning of the clinical trials. The current Audio Processor is a 3-channel, digital device. A new generation, PC programmable Audio Processor is still under clinical investigation in the United States. It does use the Signia circuit and is commercially available in Europe. Last year, we signed several agreements with Siemens, one of which allows us access to their current and future digital signal processing technology for the Vibrant Soundbridge.
Beck/AO: So there will be soon be another digital audio processor used with the Vibrant Soundbridge?
Symphonix: We plan on continually offering product enhancements which will be compatible with the implanted receiver portion of the Soundbridge. Our patients will easily be able to take advantage of the newer technology by changing the external Audio Processor, which is a key advantage of our semi-implantable system.
AO/Beck: How is the system programmed?
Symphonix: In addition to screening and evaluating potential candidates, audiologists at each implanting center also do the programming of the device. Since it is very similar to programming a hearing aid, there is not much of a learning curve.
AO/Beck: Is there a role for audiologists that are not part of an implanting center?
Symphonix: We certainly hope so. The Soundbridge may be a good alternative for many of their patients. Independent audiologists might want to contact an implanting center to discuss how to work together to identify and manage Soundbridge candidates. Several implanting centers are already working with selected independent audiologists.
AO/Beck: Tell me more about the PMA from the FDA.
Symphonix: The FDA Advisory Panel meeting was on July 20, 2000. After their review and consideration, they unanimously recommended conditional approval of the Vibrant Soundbridge. Those conditions were primarily labeling related. On August 31, 2000, the FDA approved the device for the indications described earlier.
AO/Beck: What can you tell me about outcomes?
Symphonix: Patients in the clinical trial reported improved sound clarity and quality, better overall fit and comfort and perceived benefit in many listening situations as compared to their own hearing aids. There's also significantly reduced feedback, and equal or increased functional gain as compared to a patient's own hearing aid.
AO/Beck: Suppose we had a moderate sensorineural, bilateral hearing loss, and let's assume a perfectly normal middle ear. What would you expect the aided soundfield audiogram to show us regarding gain?
Symphonix: As you can imagine, each patient is different. We fit them based on patient preference.
AO/Beck: OK, well let's talk about speech audiometry. If the unaided SRT is 60-65 dB, what would you expect the aided SRT to be using the Vibrant Soundbridge?
Symphonix: The SRT is usually not very different from that of the acoustic aid, usually just more gain in the high frequencies.
AO/Beck: If I wanted to see the most significant differences between the aided and unaided performance, what factor would I look at?
Symphonix: You'd look at the soundfield aided thresholds. With the Vibrant Soundbridge we can give them lots of gain in the high frequencies without high frequency feedback; you'd also look at patient self-assessments of performance with the Soundbridge.
AO/Beck: Do you recommend patients try hearing aids before implantation?
Symphonix: The device is intended for patients looking for alternatives to acoustic amplification. We always recommend non-invasive treatments first. If the patient is doing fine with amplification and they wear acoustic hearing aids daily and they like it they are probably not looking for an alternative amplification system. It is recommended that patients have hearing aid experience before implantation with the Soundbridge.
AO/Beck: I'm still a little unclear as to why a patient would prefer the Vibrant Soundbridge and the requisite surgery over non-invasive, less expensive hearing aids.
Symphonix: We have found patients consistently report qualitative improvements. First, they report better sound quality. Sound quality is of course somewhat subjective, but they consistently report it is improved. I think the quality issue has to do with 'direct drive', that is, we don't turn the signal into acoustic sound at all, we turn it into a vibration which is directly delivered to the ossicular chain. Therefore, we have less distortion of the signal. The second factor is sound clarity. Again, many patients report clarity and the quality improvement. Additionally, we don't have occlusion or cerumen or fit problems associated with having something in the ear canal. These are nice features from the patients' perspective.
AO/Beck: Speaking of cost, how much is it and is there reimbursement to cover the costs?
Symphonix: The price of the system is $8,500 in the U.S., and we expect the overall cost to the patient to be somewhere between $15,000 - $20,000, depending upon the implanting center. Though reimbursement is not generally available, we encourage patients to discuss the alternatives with their physicians and insurance carriers.
AO/Beck: How long do the batteries last and what are the maintenance issues?
Symphonix: The batteries last about the same as the typical hearing aid and there is virtually no maintenance required for the device itself.
AO/Beck: What about monaural vs. binaural?
Symphonix: We recommend binaural amplification. Importantly, binaural can be achieved with a monaural implant combined with a monaural acoustic aid, or any other combination. Our studies indicate that 77 percent use the combination of hearing aids on one ear and the Vibrant Soundbridge in the other ear. However, there is nothing in our labeling which precludes the implantation of the second ear and we have had a couple of cases of bilateral implantation.
AO/Beck: Regarding cosmetics, have the patients been reluctant once they actually see the size of the hardware involved?
Symphonix: No, not really. They see the pictures on the website and in the literature.
AO/Beck: So, the battery and the mic and the transmitter are on the drawing board regarding a 100 percent implantable device?
Symphonix: Yes they are. Our fully-implantable implementation of the Soundbridge technology is in development and we expect our first human implant next year. The core technology is the same as that in the semi-implantable system.
AO/Beck: Thanks to all of you for your time this evening. This is a fascinating subject and I hope we can get together again soon. How can the readers get in touch with you if they have questions or want more information on the device?
Symphonix: They can call us at 1-800-833-7733, or they can check us out on the internet at www.symphonix.com.
