Richard T. Miyamoto, MD, FACS, FAAP
Arilla Spence DeVault Professor and Chairman
Department of Otolaryngology Head and Neck Surgery
Indiana University School of Medicine
HH/Beck: Hi Dr. Miyamoto. Thanks for taking time out of your schedule for me today.
Miyamoto: No problem Dr. Beck. Nice to speak with you again.
HH/Beck: Id like to start with your professional background please.
Miyamoto: I attended medical school at the University of Michigan, and I graduated in 1970. I completed two years of general surgery training in Grand Rapids Michigan at a private hospital called Butterworth Hospital, they were affiliated with Indiana University at the time. I came to the Indiana University School of Medicine for my otolaryngology residency from 1972 to 1975. After that, I was in the Air Force for two years and I did my fellowship with the House Ear Institute from 1977 to 1978. Ever since then, Ive been on the faculty at Indiana University.
HH/Beck: Dr. Miyamoto, can you tell me what it was like from your perspective as a surgeon, back in the early days of cochlear implants?
Miyamoto: It was a very interesting time when I started out because Dr. Bill House felt it was time for cochlear implant clinical trials, but he lacked support from the leading hearing scientists in the country. In fact, during the year I was in Los Angeles as a fellow, he brought just about everyone who was a big name in hearing science to the House Ear Institute to look at cochlear implants. They looked at the program and the patients, and although they were somewhat interested, their level of interest was not sufficient to motivate enough to get involved. They didnt think there was any future in this project.
HH/Beck: It must have been very difficult. I can recall reading about cochlear implants in 1981, 1982 and 1983 and thinking about the issues of implanting humans, and changing deaf people, biocompatibility, financial and insurance issuesand realizing how enormous and complex the whole thing was.
Miyamoto: It was interesting on many levels. In the early days, I recall saying, Wow this is very interesting but well never have the opportunity to really get involved. However, a few months after I left my fellowship, I was back in Indiana, and Dr Bill House called me up and said, Well Rich youve seen it. Weve had all the leading hearing scientists out here and they just wont hop on board and build the basic science we need to drive this project. So we have a new strategy, were going to launch a clinical trial. He asked me to be in that first group and I was honored to be asked. I was just recently out of my fellowship and everybody else working with Dr. House was much more established and better known than I was.
HH/Beck: What year was that?
Miyamoto: 1979, about 5 years before the FDA finally approved the single-channel cochlear implant. I actually did my first cochlear implant in 1979. The protocol that Dr. House set up required us to take our first patient to Los Angeles and do the surgery with him. Then wed come back home and set up our own rehab program. The strategy really paid off. Dr. House said because the hearing scientists wouldnt take an interest in the program, his plan was to put enough patients out there and if it worked, the scientists would have to listen to them. The rest is history it worked!
HH/Beck: What a unique time that mustve been!
Miyamoto: We actually launched the clinical trial before the FDA began monitoring medical devices. The FDA involvement started mid-stream into the cochlear implant clinical trial.
HH/Beck: I didnt realize that.
Miyamoto: Yes, it was very frustrating in those early days because the FDA was developing the guidelines as we went along because nothing like this had ever been monitored before. All of the FDAs efforts had primarily dealt with drugs.
HH/Beck: Do you remember your first cochlear implant patient?
Miyamoto: I certainly do. My first patient was the mother-in-law of one of my residents at the time and she was the one I took to Los Angeles. She had a progressive loss and she was deaf but she could lip read well. She was doing quite well as a post-lingually deafened adult and was functioning at a very high level in spite of her deafness. However, she wanted one thing out of the implant and that was to hear her new grandbaby cry. She said, If this device does no more than that, my life will be complete. She took it a lot farther. She didnt have open speech understanding but she could use the phone with a code and it really did put her back in contact. And she said, You can be the best lip reader in the world but if you dont know someone is talking to you it doesnt do any good. So even with these very early experiences we could tell that there was something there. Thats when I decided that we needed to jump into this and take it as far as it can go, but I didnt know quite where that was.
HH/Beck: Can you recall what you told patients about cautions and about expectations back in the early days?
Miyamoto: We were very conservative in what we would told our patients. We kept their expectations as low as possible. Mainly we told them the implant would give them environmental contact and help with their lip reading skills. Thats about as much as we said. However, some people took it a whole lot further than that. I have a child I implanted with the 3M House device, whos a college student now, who clearly gets open speech understanding with that old 3M House device. Hes had it his whole life and has grown up with it. He was one of the last single channel kids I did. I recall his mother came in and said, Well, hes hearing. I said, Well, yes, but he really isnt, but tell me about this. She responded, Well, he talks to his grandmother on the phone every day. And I said Really? So we started looking into this and he clearly got open set speech understanding with a 3M House device. He was hearing things that werent even in the signal as far as we could tell, but somehow he was talking on the phone to his grandmother, and he was only 4 years old. It certainly wasnt in our expectation list!
HH/Beck: I can recall that when I was at House, almost 18 years ago, we had some truly extraordinary results with the early devices.
Miyamoto: Yes, but percentage-wise it was a pretty rare event.
HH/Beck: I agree. I did see a few people with apparent open set speech discrimination back then, but they were rare.
Miyamoto: When you look at how that processor worked, it was very simple. There was a simple signal, and for a few people, that was enough. Early on, if you remember, we did pretty extensive psychological testing before implanting patients. We had IQ scores on everyone. We thought patients had to be real bright to sort out the sounds. Regarding the fellow I mentioned earlier, we questioned whether or not we should implant him because on the standardized test, he was quite average. We thought theres no chance hes going to be a superstar. There was nothing we could find to make you think that he had any unusual capabilities. But he took right off and did phenomenally well. So that was an eye opener.
I think thats why I was chosen to be the person representing single channel studies for the FDA reports. One of the issues that came up way back in the 1980s was the FDAs concern about otitis media and meningitis in kids. At that time we didnt have any real experience, but I told them the things we were doing to take those issues into account. Fortunately, nothing happened. Recently, the cochlear implant community has had a meningitis scare, but I went some twenty years without a case of meningitis. Unfortunately - we recently had one case. However, this case seems to be totally unrelated to the implant. It must be remembered that this is one case after 23 years experience and over 700 cochlear implant cases.
HH/Beck: Yes, I agree. Its important to understand those issues, and its important to keep an objective and realistic perspective.Regarding what you tell patients today..Suppose you have a patient with Menieres Disease and it has been progressively worsening for 20 years and theyve been wearing hearing aids and doing okay. Then, their hearing takes a turn for the worse and now they have 100 dB hearing loss in both ears and zero discrimination. What would you tell the patient now regarding expectations with a cochlear implant?
Miyamoto: Well, I tell them that everybody gets environmental sound contact and the implant will certainly help their lip reading. I think thats a given. But what were now saying is a little more than half of our patients are able to talk on the telephone. I was recently sitting around with our audiologists and we received a phone call from one of our patients complaining about her map. Initially, this seemed like a reasonable complaint. But when you think about it, this was a deaf person calling on the phone saying they dont like the latest map! Kind of wonderful in its own way. We are very careful to tell people there continues to be a wide range of performance and not everybody gets the maximum.
HH/Beck: Thats true, and I believe youre exactly right. To get that range of performance, somebodys going to be at the top, and someone is going to be at the bottom. Lets change topics a little please. Tell me, if you would, your thoughts as a surgeon regarding binaural implants for adults and binaural implants for kids?
Miyamoto: Well, the problem is primarily an economic problem. Having two ears is clearly an advantage. I dont think anyone who has worked with hearing aids would doubt that the second hearing aid has clear advantages. I think many of the bilaterally implanted patients do show better hearing in noise and the ability to localize sound. So theres clearly an advantage. I think the real limiting factor is what it costs to do that second implant.
HH/Beck: So, the primary issue is a financial issue, pretty straightforward?
Miyamoto: Yes. I think the other reason we all held off on the second implant back in the early days was that we were saving the other ear for a better device. But I think things are leveling off now. Were going to see some little steps forward still, but were not going to see huge jumps in performance, because the patients do so well at this point, its frankly hard to imagine doing better.
HH/Beck: Right. I mean, when youre getting to speech recognition levels of 100%, fairly consistently, its hard to really show much improvement because you have a ceiling effect.
Miyamoto: Yes, and I think thats one reason why I think its appropriate to think of bilateral implants now. Another issue is that its pretty easy to wear over-the-ear cochlear implant devices. One thing going on with research in stem cells and hair cell regeneration is that we may have a totally different biologic solution to this problem down the line in decades to come.
HH/Beck: Have the universal newborn hearing screening programs impacted cochlear implant candidacy?
Miyamoto: Absolutely. We recently implanted a youngster who was only six months old! The family is actually not from our area. They are from Augusta, Georgia. The mother called me, introduced herself, and told me, This is the situation. My little guy failed his newborn screening test. He has no otoacoustic emissions, no auditory brain stem response, weve had a hearing aid on for two months and theres absolutely nothing. He needs a cochlear implant. When will you do it? Hes about three months old.
HH/Beck: Some of the parents know more about hearing loss than the pediatricians!
Miyamoto: Many parents are quite sophisticated. Particularly if they come through a newborn screening program and work with an excellent audiologist right away. By the end of three or four months they pretty much know if nothings happening with the hearing aid and so theyre pushing for a cochlear implant. I think everyone accepts the fact that intervening by six months is really worthwhile. Thats why we set up our infant perception lab. We demand that children have a hearing aid trial either under our observation or with someone who is knowledgeable in assessing youngsters. I recall when I started our first pediatric study here our audiologists did not feel confident evaluating children less than four years of age. So for a couple of years our youngest child was four and even that was a stretch. But now as people are more familiar with new assessment tools, and as diagnostics have improved dramatically, its easier. We pretty much know theyre going to get a whole lot more sound with a cochlear implant than someone with a corner audiogram and a hearing aid.
HH/Beck: I think I remember that you guys did a study comparing vibrotactile aids to cochlear implants quite a few years ago. Can you tell me about that?
Miyamoto: When I first set up our studies here, we did a comparative study with tactile aids because the tactile people were saying Our patients can do everything with a tactile aid your implant patients can do. However, I couldnt really get good information about the abilities of the tactile patients, so we did a comparison study here and we actually matched patients and did it all properly. Our study showed that tactile people just didnt match up to the cochlear implant people. We had a difficult time keeping that study going in the longitudinal manner because the parents would run into each other in our lab and most of our tactile kids defected and became implant patients after a year or so of that!
HH/Beck: Dr. Miyamoto, it had been a pleasure spending so much time with you. Thanks so much for your time and knowledge.
Miyamoto: Dr. Beck, it has been a lot of fun. Thank you too.
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