Interview with Jay T. Rubinstein M.D., Ph.D. University of Washington, Seattle, Washington

Beck: Good morning, Dr. Rubinstein. Thanks for meeting with me today.

Rubinstein: Good morning Dr. Beck. Thanks for the invitation.

Beck: For the benefit of the readers, would you please tell me a little about your professional education and experience?

Rubinstein: I attended medical school at the University of Washington Medical School in Seattle, and I graduated through a combined M.D. and Ph.D. program, which I completed in 1987.

Beck: What was your area of study for the Ph.D.?

Rubinstein: Biomedical engineering, with a focus on cochlear implants.

Beck: Very good, and where did you do your residency and fellowship?

Rubinstein: My residency was at Massachusettes Eye and Ear Infirmary and I subsequently did two fellowships. I did a research fellowship at MIT in Boston, and then a clinical neurotology fellowship from 1994 through 1995 at Iowa, working under Dr. Bruce Gantz. Currently, my primary emphasis is on cochlear implants and acoustic neuromas.

Beck: Very good. Dr. Rubinstein, what can you tell me about the difference between cochlear implant (CI) outcomes from the time you implanted your first cochlear implant, as compared to 2005?

Rubinstein: It has changed dramatically. Some ten years ago, we spoke to patients about cochlear implants as being beneficial to speech reading and improved perception of environmental sounds. At this time, most implant patients acquire open set speech discrimination, and the majority can even speak on the phone. In fact, a bit over 20 years ago, most CI patients achieved essentially 0 percent with regard to their open set word recognition scores. In 2005, they typically get over 50 percent monosyllabic words. So the outcomes of cochlear implantation have improved dramatically and I anticipate they will continue to improve.

Beck: With all due respect to the FDA guidelines regarding the recommended 12 month old minimal age for cochlear implantation, and knowing that the earlier a child is implanted the better the outcome is likely to bedo you ever see kids that are 7, 8 or 9 months old and decide that this particular child is a cochlear implant candidate?

Rubinstein: Sure. I think we all see those children.

Beck: And I know physicians can choose to go off label and implant appropriate children at younger agesbut it must be very disconcerting?

Rubinstein: Well it is. In fact we need improved tools to more accurately identify and manage these kids earlier, and I think those too, are coming along.

Beck: I agree. When I see a baby that may be physically well developed for an 8 month old, and appears to be a CI candidate as best I can tell, I have to tell the surgeon and parents my thoughts and opinions based essentially, on a lack of behavioral and neurophysiologic tests, and no improvements with hearing aids. I cant say Result X or Result Y tells me the child is a cochlear implant candidate.

Rubinstein: I totally agree, and thats why the relationship and the knowledge of the otolaryngologist and the audiologist working together to identify these children is so important. But getting back to it being disconcertingIt really is, and we need to continue to attend to research questions and answers to try to better define these candidates and to remove some of the clinical ambiguity.

Beck: I know you have only very limited time here this morning, as we are currently at the CI-2005 Meeting in Dallas (March, 2005), but I wonder if you can tell me about your ongoing research?

Rubinstein: For the last ten years, Ive been working on a cochlear implant speech processing strategy, to reconstruct within the auditory nerve, the normal pattern of firing that occurs in a normal hearing ear, as a result of acoustic stimulation.

Beck: And is this based on temporal patterns?

Rubinstein: Yes, temporal patterns. One of the big differences between electrical and acoustic stimulation is in the temporal patterns produced in the auditory nerve. When you use electrical stimulation, the inner hair cell synapse is removed from the sound path. Were working to mimic the inner hair cell synapse while using electrical stimulation to take advantage of the electrode-neural interface to produce more of a physiologic output pattern. We found through animal studies and a computer model that we could electrically simulate the normal auditory nerves temporal firing patterns.

Beck: That would be amazing. How far along are you?

Rubinstein: When the Clarion C-II was introduced in 2001, we did some initial psychophysical studies in our early patients. The Clarion C-II was the first cochlear implant with the flexibility and capability to implement our temporal-based approach. Our psychophysical measures confirmed behaviorally what we had predicted and so the Clarion C-II and HighRes 90K are now being used to deliver sound using this processing strategy.

Beck: How many folks are evaluating the new strategy?

Rubinstein: We have about 20 subjects at this time wearing the Advanced Bionics unitsome have the body worn units and some have the BTE units. Weve had some very encouraging results, and so were continuing to explore the options and alternatives. We have seen improved speech perception in quiet and in noise in some subjects wearing the new strategy. But again, were still exploring and researching, but its encouraging.

Beck: This is really fascinating work Dr. Rubinstein. Thanks for the update.

Rubinstein: My pleasure, thanks for your interest in our work.

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For more information on cochlear implants, visit www.bionicear.com