December 19th, 2012 by Rachel | Tags: Cochlear Implant, History, MED-EL, Well-Known People | 8 Comments »
Creating an incredible product that changes the lives of thousands people around the world does not happen overnight. Cochlear Implant Online presents an exclusive interview with Dr. Ingeborg and Professor Erwin Hochmair, founders of global hearing implant company, MED-EL. They share what inspired them to research cochlear implants, the history of their research in the field, and the challenges they faced.
When did you first learn about hearing loss?
ERWIN: Most of us know people who have some disabilities, who, for example, are deaf or blind. Deafness appears to be more difficult to cope with than blindness, since, as Helen Keller said, it separates from people, whereas blindness separates from things.
But my real exposure to deafness and the appreciation of its consequences came later, after I had been asked by Professor Burian, who was the head of the ENT-Clinic at the University of Vienna, whether I would be willing to design a device which could be of help to deaf people. This was in 1975. At a conference, Burian had learned about Dr. William House´s attempts to restore hearing in deaf patients by electrical stimulation of the auditory nerve.
At that time I was Assistant Professor at the Institute of Physical Electronics of the Technical University of Vienna. From 1970 through 1972 — just after my Ph.D. in Electrical Engineering – I had spent two years at the NASA Marshall Space Flight Center in Huntsville, Alabama, as a Research Associate designing analog integrated circuits in complementary MOS-technology. This technology, also called CMOS, is now the basis for almost all electronic devices, from computers to mobile phones. In the seventies this technology was just beginning to replace older, less efficient technologies in the digital domain. No one else but me was considering its application in analog circuits. Therefore, when I had returned to the Technical University in Vienna being very enthusiastic about these new possibilities in analog circuit design, I was quite undecided whether I should sidestep from my ambitious plans and work on something which eventually might become a cochlear implant.
What inspired you to pursue the research and development of the CI?
ERWIN: It so happened that just at that time there was this very attractive young female Electrical Engineering-student, who was just finishing her Diploma Thesis. Her name was, and is, Ingeborg. I asked her whether she would be interested in designing some yet unspecified electronic aid for deaf people – and she immediately agreed. Combining engineering and medicine to help people was what she had always dreamed of. She stated: we have to do it, the sooner, the better! And we did.
INGEBORG: I still have that sense of urgency to help people to overcome hearing loss as a barrier to communication and to help them to increase their quality of life. These feelings have never stopped, and continue to inspire us at MED-EL every day.
Can you share the very first CI procedure you completed?
ERWIN: Our first CI project was supported by a grant from the Austrian Research Council in the amount of ATS 110,000; roughly equivalent to $11,000 USD. In our naïve view, it appeared quite obvious to us that in order to enable implant wearers to differentiate between frequencies, i.e. to discriminate different pitches, we had to design a device which was able to stimulate the fibers of the auditory nerve at several locations within the cochlea, not just at one site like the House Implant.
That meant that we had to design and build a multichannel intra-cochlear electrode, and we had to develop all the implantable and the external electronics for the transcutaneous transmission, the coding and decoding circuits and the electrode driving circuitry – all that at minimum power consumption.
Drawing from my previous analog CMOS-experience, combined with some newly acquired skills of how to design and build a biocompatible hermetic housing for our circuit, we were able to finish the whole implant within 1 and ½ years – an unbelievably short time from today’s point of view. It was implanted on December 16, 1977, and was the first micro- electronic multichannel implant in the world.
Our enthusiasm for CIs was not always shared by the scientific community. For example, a well known ear-physiologist said to me: you have 8 stimulation sites, in the normal ear the auditory nerve has 20 000 nerve fibers – your device will never work. Years later, when he made a similar remark about the auditory brainstem implant, which, by the way, also turned out to be overly pessimistic, I reminded him of his first prediction, and he quipped: You just had luck.
And he was right. Even now I am amazed about the performance of some users, considering the crude approximation of the normal function of the auditory system afforded by even the most sophisticated implants.
In my opinion there are two reasons for this serendipity. Most important is the enormous plasticity of the brain, which adapts to even weird representations of the sound input and, after some experience, let them appear as “natural”(mimicking the natural pattern as close as it is technically possible helps, of course). The second reason for the astonishingly good speech understanding of some CI-wearers is the robustness of the speech signal per se. It had developed as a reliable means for communication even under unfavorable circumstances, and it does not tax the ear to its limits. Therefore, implants with their fairly restricted capabilities do provide sufficiently recognizable information to allow “reconstruction” of the message. This is not quite the case with music, however. It certainly is a challenge to further advance CIs such that a CI-wearer can enjoy music considerably more than it is possible today.
Another, more recent, contribution to the ongoing improvement of CI performance is the widening of indications, resulting in the implantation of patients with more hearing and thus a better past auditory experience.
What challenges did you face in researching and developing the CI?
ERWIN: Back to our early efforts in rigging up our CI-system. Our goal was to work with our first patients to develop a coding strategy which was hoped to eventually provide some kind of speech understanding. This turned out to be more difficult than expected. Too many unknown parameters were waiting to be determined.
Therefore, we changed the direction of our research by 180 degrees and designed a much simpler passive broadband single channel implant which was very transparent to any type of stimulation signal. It allowed us to experiment with a wide range of stimulation signals. In 1979, one of our first broadband single channel patients achieved open set speech understanding. She, as well as a number of other patients, spent many hours, days, and years to help further improve our processing. Her initials are C.K., and these became well known within the CI-community.
What were the most memorable moments of your journey in researching and developing the CI?
ERWIN: Designing and further developing CI’s is so intriguing because it involves many different fields of science and engineering. Besides physiological and medical aspects it poses challenges in many engineering disciplines such as circuit design, microelectronics, radio frequency engineering, signal processing, electrochemistry, mechanical engineering, material science, information technology, software development, control theory, acoustics, and linguistics.
But, most important, it is not just an engineering task, the goal is to help people, and it is really addictive to watch a patient, a child, at first fitting, or seeing them perform later on.
I know that this highly rewarding environment motivates many of our coworkers and drives them to do their best.
INGEBORG: Even after more than 30 years there are so many special moments I feel very grateful to experience. However regarding the early days, I will always remember our very first patient who contributed so much to the development of our implants as well as the look in the bright eyes of the very first child ever implanted, when they could hear for the first time the processor was switched on.
How did you establish the company and launch the CI commercially?
ERWIN: During a half-year stay at Stanford University, the 3M company found out about our research and our results. The company wanted to enter the hearing device business – and our CI was intended to be the flagship. At first we were quite happy having found such a potent company willing to commercialize our CI-system – only to find out after several years that this large company geared to mass production was not able to introduce such a delicate product requiring dedicated and caring engineering support. The cooperation was terminated in 1988.
In the meantime, I had been appointed a professorship at the University of Innsbruck. We felt that we had learned enough – mainly what not to do – to be in a position to wage the foundation of our own company. Since its foundation in 1989, Ingeborg has headed the company. I stayed at the University, keeping strong ties with the company via common research and development projects. The first two employees were hired in 1990.
The big challenge was, not surprisingly, financing the company and its growth. Government support for the transition from the university to the commercial environment was practically nonexistent. Fortunately, patent rights were not in the focus of the universities then, thus we were able to make the most of our patents ourselves. During our 3M adventure, the Austrian Research Fund received a license fee from 3M. Since the company was tiny, the burn rate could be kept low, allowing us to get along with bank loans, bills payable, and a risky mortgage on our home.
In hindsight, it was fortunate that the CI market was fairly small. This allowed the company to grow in step with the market, not having to fight to enter an existing market dominated by big players, and – not just a minor achievement – stay an independent privately owned company.
In the years that followed several implant generations were developed. The first big step was the introduction of the extremely successful COMBI 40, an 8-channel implant in a ceramic case featuring the CIS coding strategy. Thus we had gone full circle from our first design via the analog broadband implant system “back” to an 8-channel pulsatile concept being (superficially) similar to this first design.
Our engineers were able to reduce the power consumption by a factor of 80, allowing the replacement of the body worn processor by a BTE processor, culminating now in the most recent development, the single unit processor, the RONDO, which was recently approved by the FDA.
In the meantime, many other new design concepts and breakthroughs were achieved, discussing them would provide stuff for at least another interview.
INGEBORG: In addition to these other reasons, the enthusiasm of all our employees was and still is a key element in establishing and respectively developing the company. You can feel the passion to work on something that could help people to effectively raise their quality of life.