Interview with Steve Staller Ph.D., Vice-President of Quality, Clinical and Regulatory Affairs for Cochlear Americas

AO/Beck: Good Morning Dr. Staller. Thanks for joining me today. Before we get to issues related to cochlear implants, I wonder if you'd mind reviewing your education and professional history for me?

Staller: Hi Dr. Beck. I did my undergraduate work at UC Santa Barbara in audiology and speech pathology, and then earned my master's and doctorate from the University of Colorado.

AO/Beck: What was your dissertation topic?

Staller: It was on The 40 Hertz Event Related Potential in Children .

AO/Beck: Steve, my understanding is that the 40 Hz event related potential is similar to the relatively new ASSR. Is that correct?

Staller: Yes, in some respects. The 40 hertz event related potential was essentially a derivative of the middle latency response that was enhanced by using a specific stimulation paradigm. It is interesting that ASSR is turning out to be an excellent assessment tool for cochlear implant candidacy in young children. ASSR is frequency specific at very high stimulus levels which is important for differentiating severe from profound hearing losses.

AO/Beck: OK, back on topic.....when did you start with Cochlear?

Staller: I've been with Cochlear since 1987. Before joining Cochlear, I was Executive Director of the Denver Ear Institute, which was a small non-profit research and clinical group in Denver. In the late-1980s, I was recruited by Cochlear to help manage the first Nucleus pediatric cochlear implant clinical trial.

AO/Beck: And to frame that within the cochlear implant timeline, when was the FDA approval for cochlear implants in children?

Staller: The Nucleus 22 was approved by the FDA for children in 1990.

AO/Beck: And I guess the FDA approval for adults was 4 or 5 years before that?

Staller: Yes. The Nucleus 22 was the first multichannel cochlear implant approved for both children and adults. It was approved for post-linguistic adults in 1985. We started the U.S. operation back in 1983 and the original adult clinical trial started that same year. We started the pediatric trial in 1987, and that's when I came on board at Cochlear.

AO/Beck: Can you please tell me what your current position at Cochlear is, and what are the responsibilities you address?

Staller: I'm the Vice-President of Quality, Clinical and Regulatory Affairs. I'm responsible for field clinical support, customer training, conducting clinical trials and collaborative research in the Americas Region. I'm also responsible for the regions Quality and Compliance programs which have become a growing area due to new regulations such as HIPAA.

AO/Beck: Sounds like that keeps you pretty busy! Steve, I'd like to ask a few important, but somewhat unrelated questions, to set the stage a little for the readers who may not have followed cochlear implants for the last few years.

First of all, how many people throughout the world have cochlear implants?

Staller: There are around 65,000 cochlear implant recipients, about 50,000 of whom are using a Nucleus device.

AO/Beck: That's incredible. Let's talk about the names Cochlear America, Cochlear and Nucleus. Please explain which is the preferred name, and what do they each mean?

Staller: Nucleus is our technology brand and Cochlear is our company name. Cochlear Americas is the regional business entity based in Denver, that supports North and South America. Our corporate headquarters, manufacturing facility and product development resides in Sydney, Australia.

AO/Beck: Steve, what is the current product offering?

Staller: Our current product line is known as the Nucleus® 3 System. It consists of Nucleus 24 Contour™ implant, the SPrint (body worn) and the ESPrit™ 3G ear -level processor. The ESPrit ™3G is our third generation behind-the-ear speech processor. We originally released a BTE processor with the Nucleus 24 line that was approved back in 1998.

AO/Beck: Please explain the term Neural Response Telemetry.

Staller: Neural Response Telemetry (NRT™) is a unique feature of the Nucleus 3 system that allows audiologists to examine the responsiveness of the cochlea to the stimulation from the implant at up to 22 stimulation sites. NRT provides an objective measure of the auditory nerve's response to electrical stimulation via a quick, easy procedure that does not require sedation or external recording electrodes. NRT is an invaluable clinical tool used to program difficult to fit patients such as very young children and prelinguistically deafened adults . Basically, we use the NRT measurement in the same way you might use an electrocochleogram (ECochG) or an auditory brain stem (ABR) response to measure the activity of the auditory nervous system and to assist in programming the cochlear implant. The technique is based on work done by Drs. Paul Abbas and Carolyn Brown at the University of Iowa. We released NRT in 1998, and over the past five years we've made continuous improvements to both the software and the hardware. We have now gathered experience in more than 300 clinics and more than 2000 patients and have developed clinical applications and guidelines to assist clinicians in using NRT. NRT can be measured in the OR during implant surgery to estimate a first processor program to reduce initial fitting time.

AO/Beck: What are the current cochlear implant candidacy indications?

Staller: Candidacy for cochlear implantation has expanded dramatically over the last few years. When I started with Cochlear, you could only implant profoundly deaf adults who lost their hearing post-linguistically. The first children to be implanted were older adolescents or teenagers. Current indications allow children as young as 12 months of age to be implanted. Additionally, compared to the early days, people with significant amounts of residual hearing might be considered implant candidates. For example, adults can have as much as 50% open set sentence recognition while using their hearing aids without lipreading and be considered for implantation. The criteria have changed dramatically due in part to the dramatic improvement in implant outcomes that we've seen over the years. When I started at Cochlear, the average adult understood about 13% of sentences without lip reading when using their implant. Now we routinely see patients who can understand 90% of sentences without lip reading and they can effectively use the telephone.

AO/Beck: I've spoken with dozens and dozens of cochlear implant patients in the last year. My understanding is that it's now reasonable to predict 80% of new cochlear implant patients will be able to use telephones. Does that sound right?

Staller: That's about right.

AO/Beck: That's really staggering. I remember the first cochlear implant patients I worked with 20 years ago. We would routinely discuss the benefits of implantation as being an aid to speech reading, and the only sounds we were comfortable anticipating were loudness cues, and timing cues. That was about it. It was the rare patient that got true open set speech recognition. And I cannot recall any of the early patients using the telephone for general conversation. The progress in cochlear implants has occurred at an amazing pace.

I want to take a step back if I may Steve. Can we discuss the differences between the BTE and the body-worn processor versions? Is there a specific difference besides the physical size and the cosmetic issues?

Staller: The ESPrit™3G is the first cochlear implant speech processor that combined greatly improved cosmesis with a number of technological advancements. The ESPrit™3G incorporates directional microphones, multiple programs, noise suppression algorhithms and something we call Whisper . The Whisper setting functions much like the full dynamic range compression circuits used in digital hearing aids. Using the Whisper setting, individuals improve their speech perception abilities for soft to moderate sound levels, compared to conventional programming.

We have also significantly improved the battery life of the processor. The ESPrit™ 3G, runs for approximately 52 hours before the batteries need to be changed. As you know, Doug, we have a strategic alliance with Phonak and all of our speech processors are designed to be compatible with the Phonak MicroLink technology. This allows easy compatibility between our cochlear implant system and the FM system most widely used in the classroom. The FM MicroLink connection in the ESPrit 3G is a tiny little attachment to the bottom of the speech processor, and it's a wireless connection. There's also a built-in telecoil in the ESPrit 3G that allows recipients to communicate in their work environment, and then flip a switch and talk directly over the telephone.

Cochlear's design philosophy has been focused on providing functionality for recipients in their everyday lives. We try to think in terms of recipient benefit, and the most important thing we do is provide technology that allows them to function well in the environments where they live, work and play. Features such as the built-in telecoil, front-end sound processing, advanced noise reduction algorithms, directional microphones, beam forming technologies, are all examples of this philosophy focused on improving the recipient's quality of life.

AO/Beck: And it sounds like there are more features on the ESPrit BTE than the standard body-worn unit. Is that correct?

Staller: There are a number of features unique to the ESPrit 3G but there are also some unique features on the body-worn (SPrint) platform as well. One unique DSP based feature is known as Adaptive Dynamic Range Optimization or ADRO. ADRO is a front-end sound processing technology a series of logic rules to dynamically adjust gain for all 22 channels of the Nucleus system to optimize loudness and improve audibility and intelligibility of speech in a variety of listening environments. In layman's terms ADRO works much like the graphic equalizer on your stereo system.

AO/Beck: Steve, what about the ability to retrofit new technology to patients previously implanted. Can you address that for a few moments?

Staller: Yes. We think that's absolutely essential and that's the basis for a lot of work that goes into our product development. As an example, our first implant, the Nucleus 22, had a series of upgrades including a variety of coding strategies, a variety of speech processors, and software changes that allowed us to improve the technology for our recipients, without additional surgery. We were able to take adult recipients for the Nucleus 22 and improve their average sentence recognition by more than seven fold, 13% speech understanding for sentences without lipreading to almost 80% speech understanding, via external upgrades over the years.

We plan to continue this commitment to upgrades with the Nucleus 3 system. While the Nucleus 3 system incorporates the latest, most advanced cochlear implant technology available in the world today, it has been designed to serve as an expandable platform for the future. We have engineered the Nucleus 3 system with the technology to utilize future enhancements in speech coding strategies and speech processors without requiring new implantation. This product upgradebility is the realization of our corporate philosophy stated as Hear Now... and Always.

AO/Beck: That's amazing, and I think it is very important. I can easily imagine some people thinking they'll hold off on receiving their cochlear implant because they want to be sure to get the newest and best technology, and given that the changes are vast and ongoing, there really is never a true end point. Therefore, I think a commitment to providing upgrades and other improvements to previously implanted people is very important.

A couple more miscellaneous topics, if you'll indulge me...

Can you please tell me your thoughts on candidacy criteria for potential cochlear implant recipients?

Staller: Well, were actually doing a better job with ideal patients, and we're doing a better job with patients that we thought of traditionally as having less potential for success using a cochlear implant. So candidacy criteria continue to change, because the outcomes have improved dramatically.

That message is one of our challenges. A number of clinicians who don't deal with cochlear implants on a day-to-day basis still believe cochlear implant outcomes are relatively modest, and do not consider referring individuals other than those with profound deafness and who have recently lost their hearing. Many individuals with less severe hearing loss, longer durations of loss and children who were born deaf are deriving significant benefits from implantation. As we discussed earlier, indications for use based on improved outcomes have broadened and will continue to expand in the future. That said, there are certain patient characteristics that correlate with better utilization of cochlear implants. For children, the most important factors are the age of implantation and the effectiveness of their rehabilitation and management postoperatively. Basically, the younger a child is when implanted, the better the potential outcome over the long-term. Effective habilitative intervention with an emphasis on spoken language is also a very important factor. In adults, the length of deafness before implantation and effective use of amplification are important factors relating to successful implant use. So the general rule is, earlier implantation is better.

AO/Beck: Can you talk a little bit about how to identify deafness in the pediatric population?

Staller: Clinical audiology has come a long way in being able to diagnose and precisely define the levels of hearing loss in very, young children. Improved behavioral techniques are broadly utilized in the clinical community and that is wonderful. But for many children, early and accurate identification of hearing loss is accomplished using evoked potentials which measure the response of the brain and nervous system to sounds. In many cases, this occurs during the peri-natal period in the hospital as part of a newborn hearing screening program. Techniques such as the ASSR mentioned earlier have extended the diagnostic range to more effectively identify young implant candidates.

AO/Beck: Steve, what are the current thoughts on critical periods for language acquisition?

Staller: Children who are born deaf and implanted early, have the greatest opportunity to acquire speech and language skills at age appropriate levels. Research from Drs. Svirsky and Kirk from Indiana University suggested that children implanted under 3 years of age acquire speech perception, expressive and receptive language capabilities faster than children implanted later in life. These young implanted children demonstrate similar language rates to their normal hearing peers, although they retain a gap from their period of hearing deprivation before surgery. So as mentioned before, younger is generally better.

AO/Beck: One thing that I think many parents and patients will be interested in is the issue of insurance and reimbursement. What can you tell us?

Staller: The majority of private carriers and Medicare fund cochlear implants, surgery, device programming and subsequent management. Unfortunately in some cases, the rate of reimbursement is inadequate to cover the actual costs, particularly in the area of audiological services. This is particularly true of Medicare coverage. The implant industry, in collaboration with various professional organizations and governmental agencies, recently succeeded in avoiding a major reduction in Medicare reimbursement rates. The best thing for the patients and families to do is to work with their hearing professionals to find out exactly what their insurance will and won't cover. Cochlear, along with other implant companies, provides an insurance preauthorization service which can assist candidates and families in determining their level of coverage. We also work with insurance companies to improve the levels of coverage.

AO/Beck: Generally speaking, if I have Medicare as my primary insurance, will they cover the cochlear implant and related expenses?

Staller: Yes, although as mentioned before the levels of coverage may be inadequate. This has become a particularly important issue for Medicare providers. Cochlear has a number of initiatives to impact the levels of Medicare coverage. We recently met with Mr. Tommy Thompson, the Secretary of Health and Human Services, to try and raise the awareness of the situation.

AO/Beck: Steve, what have we learned about electrical stimulation over the past 20 years?

Staller: What we've learned is that the brain is a remarkably resilient organism. As we've improved the technology and been able to represent speech information in more and more sophisticated ways through multi-channel cochlear implant electrodes and by moving the electrode closer to the ganglion cells with perimodilar arrays such as the Contour, we're able to improve outcomes by faithfully representing pitch, amplitude and timing characteristics of speech. We believe the future lies in being able to recreate the natural neural code within the cochlea.

AO/Beck: This wouldn't be a complete interview if I didn't ask you what you think might happen regarding new developments in cochlear implant technology?

Staller: There are a number of exciting technological developments on the horizon. One big step will be a totally implantable cochlear implant. We envision that coming to fruition within the next couple of years. A totally implantable cochlear implant is a technology that would allow us to place the microphone, speech processor, the implant's electronics, and the battery technology and the electrode -- all under the skin. We have overcome 95% of the technical hurdles in achieving this and so we anticipate being able to start the first human implants within the next few years. In some people's mind, that's the end of the technology road. But we don't believe that. We believe that a totally implantable would be one of several options available. . If a recipient were to choose a totally implantable cochlear implant, they would be trading off invisible hearing, for perhaps a less flexible, less upgradeable platform. In addition, as with a pacemaker, a follow-up surgical procedure would be required at some point in the future to replace the battery and/or electronics. Alternatively, the recipient could use the totally implantable as a conventional cochlear implant with an externally worn processor and battery.

AO/Beck: Any other future-based issues?

Staller: Many of them, but I think we are running out of time. One of the most interesting areas we're working on is to combine the best aspects of traditional amplification with electrical hearing, in devices known as hybrid electroacoustic devices. Essentially, in individuals with severe precipitous high frequency hearing losses, we're delivering high frequency speech information electrically through a very short electrode array in the basal portion of the cochlea and low frequency speech cues through acoustic amplification in the same ear. This concept is based on the work of Dr. Bruce Gantz from the University of Iowa. Dr. Gantz has been able to preserve the patient's preoperative hearing levels and demonstrate significantly improved speech perception compared with their preoperative hearing aids. This technology is the first step in a whole new category of implanted devices which have the potential to help a large number of hearing- impaired individuals who are currently underserved.

AO/Beck: That's amazing. I'd love to see that technology and those patients one of these days. In the meantime, I am very grateful to you for your time and expertise. Thanks for joining me today.

Staller: My pleasure Doug. It's been fun and thought provoking. Thanks for helping to get the word out on cochlear implants.

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