Interview with Gerald Popelka Ph.D., VP of R&D, Everest Biomedical Instruments, Professor of Otolaryngology - Washington University
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AO/Beck: Hi Jer, it's always nice to speak with someone from all the way across town!
Popelka: Hi Doug, good to speak with you too.
AO/Beck: Let's start by learning a little about you. When and where did you get your Ph.D.?
Popelka: I got my Ph.D. from the University of Wisconsin in Communication Sciences in 1974.
AO/Beck: After earning your Ph.D., what was your first position?
Popelka: I accepted a faculty position at the School of Medicine at New York University in New York City. I stayed there for two years and then did a post-doc at UCLA. At UCLA I was involved with acoustic immittance measurements from 1976 through 1980.
AO/Beck: If memory serves, the immittance battery was just introduced at that time and I think it became widely available commercially as of about 1974?
Popelka: Yes, that's correct. I was also a member of the ANSI standards committee on acoustic immittance measurements. The writing group was a typical ANSI committee that included academicians, clinicians and device manufacturers. Some of the group members were Laura Wilber, Jan Painter, Paul Madsen, Rufus Grason and a few others.
AO/Beck: And then from UCLA and ANSI, where did you go?
Popelka: In 1980 I went to Washington University in St. Louis and I've been there ever since. I've had several positions there, Head of Audiology (1980-1994) and Director of Professional Education (1990-1996) at Central Institute for the Deaf and Professor in the Medical School (1996-present).
AO/Beck: Jer, I know one of the many projects you were involved with at CID was the digital hearing aid project. Can you tell me a little about that?
Popelka: Sure. In 1980 I got together with an electrical engineer named Maynard Engebretson and a professor in Electrical Engineering, Robert Morley, also an electrical engineer, and we conceived the first programmable and fully digital hearing aid. We applied for a patent and that was granted to in 1985 with the three of us as inventors. The work on this project was funded by many federal grants. Though there were 57 claims on the patent, the two main new features were programmability and full digital processing. Then, in 1988, programmable hearing aids began to come out from other manufacturers, and of course, there were lawsuits flying back and forth over the patent. As time went on, the other hearing aid manufacturers began to prepare to produce full digital hearing aids. In 1996, all of the major domestic and international hearing aid manufacturers formed a consortium and bought the patent from Washington University and Central Institute for the Deaf. Of course patents are valid for 17 years, so there's only another year left on the patent. So basically, the hearing aid manufacturers now own the patent. Our original patent applies to all programmable and all full digital hearing aids manufactured for another year. This is about half of the two million hearing aids sold annually in the US and at least as many sold internationally.
AO/Beck: Timing is everything! Sounds like you even beat Nicolet with their Phoenix project?
Popelka: Yes, we filed our patent and were building custom, low-power computer chips and put them in hearing aids quite a few years before their product came out.
AO/Beck: OK, well let's move forward to Everest Biomedical. When and where did that come from?
Popelka: The complete story of Everest probably begins in 1972. That was the first time I put a probe in a baby's ear. The idea was to learn about physiological measures related to audition, acoustic immittance measures, acoustic reflex measures and ABR in infants. I received a US-Israel BiNational Science Foundation grant and went to Israel and performed a lot of experiments involving neonates at that time and was already committed to developing better means for detecting hearing loss at birth. Then in 1980, I got sidetracked into the digital hearing aid effort. Once the digital hearing aid project was completed, around the early 1990s, I returned to the neonatal measurements. At that time I switched my grants from digital signal processing in hearing aids to otoacoustic emissions in neonates. In 1992, I won the Knud Terkildsen Research Fellowship and went to Denmark for half a year to work on basic science related to OAEs. Then it was back to St. Louis where I began writing research grants again with Bob Morley. Soon we were developing new technology and essentially taking big desktop measurement devices and making them very tiny. I and Bob Morley put in new grants to NIH and got them funded. After a few basic studies on neonates were completed, we developed digital signal processing technology for advanced OAE and ABR measurements in neonates. Through that process, I worked closely with Elvir Causevic and his brother, Eldar. Elvir was a doctoral student of Morley's in electrical engineering who was studying under Morley and me. He completed his doctorate this year. Eldar also received an electrical engineering degree from Washington University. So basically, Elvir and Eldar founded Everest Biomedical Instruments in 1996 and I have been involved with them ever since, joining them full time last year. We have hit (been funded) 100 percent of out grant applications and continue to conceive and develop innovative, and new biomedical instruments.
AO/Beck: What was the role of Everest from your vantage point at that time?
Popelka: Originally we wanted to develop the universal neonatal screening concept and we were committed to that well before the NIH Consensus statement was released. We believed that because hearing measurements in neonates are very difficult, and because there are simply not enough audiologists in the whole world to screen all the babies being born, we realized we needed to develop neonatal hearing screening equipment that was self-contained, easy to use, accurate and dependable for the screening process to succeed. Specifically, we were gearing up for developing tiny battery operated handheld devices yet with sophisticated super computers in them. That was why Everest was founded.
AO/Beck: And so the Everest Audio Screener was born.
Popelka: Yes, that's right. The Everest AUDIOcreener is indeed a screener, but it has the sophistication to provide some information previously available only in diagnostic, desktop equipment. Currently, AUDIOscreener can perform ABR and OAE, and later this year we'll be adding tympanometry, all in a hand held, battery-operated unit. Additionally, it has an infra-red interface so there is no need to hook it up to cables to print data or transfer results to another computer. The device is totally stand alone.
AO/Beck: Is this product available only through Everest?
Popelka: Right now that's correct, it is available only through Everest, but very quickly it'll be available through the usual distributors.
AO/Beck: Jerry, here's where the rubber meets the road...what does it cost?
Popelka: There are a number of configurations, An OAE alone unit is $4000.00, an ABR alone unit is $10,500.00, and the combined unit (OAE+ABR) is $14,500.00.
AO/Beck: What is the power supply for the unit?
Popelka: The power supply is a rechargeable battery that runs for 24 hours on a single charge. It also can be operated while the battery charger is plugged into the wall outlet.
AO/Beck: How long does it take an experienced person to perform an OAE after the unit is setup in the ear.
Popelka: About 10 to 12 seconds.
AO/Beck: Is this a pass/fail system?
Popelka: Yes, both the default OAE and ABR configurations produce a pass/fail result. We wanted the unit and software to be as simple as possible so non-audiologists could competently perform the basic screening.
AO/Beck: Is the OAE software based on distortion products or transients?
Popelka: Distortion product otoacoustic emissions.
AO/Beck: Do you anticipate that we'll see standards on DPOAEs in the near future?
Popelka: I sure hope so. I am pushing for standards on every front I can, for both OAE and ABR. People ask me all the time What is the sensitivity and specificity of the device? However, the question we need to focus on is....What is the sensitivity and specificity of the method or protocol? Our device can implement many different protocols, methods and criteria, and each will have an impact on the sensitivity and specificity. Currently, we have set the default screening criteria based on the NIH recommended parameters. The NIH study that determined these parameters was based on measurements of 7192 babies. That study was just published in October, 2000 in Ear and Hearing.
AO/Beck: What about getting the referral rates down? How do we go about that?
Popelka: The only way anyone can accomplish that at this time is to perform both ABR and OAE. In fact, that's what the large NIH, multi-center study recommended last October. The AUDIOscreener is the only handheld device that can implement the NIH-recommended procedure that includes both OAE and ABR.
AO/Beck: What about the ABR side of the unit - Is that screening only or combined screening and diagnostic?
Popelka: Screening, but it has key diagnostic features. The current unit can do both. For example, though the default setting produces an automated click ABR result, you also can choose tone bursts as the stimuli so you can really get a powerful ABR profile, based on the capabilities of the user. In other words, for both OAEs and for ABR you can use the screening mode that produces a Pass or a Refer result, or you can setup your own parameters to yield key diagnostic information, such as a series of waveforms in response to stimulus levels that sequentially decrease from 65 dB nHL in 5 dB steps so a threshold can be estimated as is done with diagnostic devices.
AO/Beck: Jerry, this sounds like another excellent product and once again, it appears that you're ahead of the curve! If the readers want to learn more about it, or discuss applications or protocols with you, how can they contact you?
Popelka: They can contact me via email at geraldp@everest-co.com, or they can visit our website at https://www.everest-co.com, or of course, they can feel free to use the toll-free phone number 1-866-662-8346.
AO/Beck: Thanks for your time Jerry. It's been a pleasure and I wish you success with the new venture.
Popelka: Thank you too, Doug.
Popelka: Hi Doug, good to speak with you too.
AO/Beck: Let's start by learning a little about you. When and where did you get your Ph.D.?
Popelka: I got my Ph.D. from the University of Wisconsin in Communication Sciences in 1974.
AO/Beck: After earning your Ph.D., what was your first position?
Popelka: I accepted a faculty position at the School of Medicine at New York University in New York City. I stayed there for two years and then did a post-doc at UCLA. At UCLA I was involved with acoustic immittance measurements from 1976 through 1980.
AO/Beck: If memory serves, the immittance battery was just introduced at that time and I think it became widely available commercially as of about 1974?
Popelka: Yes, that's correct. I was also a member of the ANSI standards committee on acoustic immittance measurements. The writing group was a typical ANSI committee that included academicians, clinicians and device manufacturers. Some of the group members were Laura Wilber, Jan Painter, Paul Madsen, Rufus Grason and a few others.
AO/Beck: And then from UCLA and ANSI, where did you go?
Popelka: In 1980 I went to Washington University in St. Louis and I've been there ever since. I've had several positions there, Head of Audiology (1980-1994) and Director of Professional Education (1990-1996) at Central Institute for the Deaf and Professor in the Medical School (1996-present).
AO/Beck: Jer, I know one of the many projects you were involved with at CID was the digital hearing aid project. Can you tell me a little about that?
Popelka: Sure. In 1980 I got together with an electrical engineer named Maynard Engebretson and a professor in Electrical Engineering, Robert Morley, also an electrical engineer, and we conceived the first programmable and fully digital hearing aid. We applied for a patent and that was granted to in 1985 with the three of us as inventors. The work on this project was funded by many federal grants. Though there were 57 claims on the patent, the two main new features were programmability and full digital processing. Then, in 1988, programmable hearing aids began to come out from other manufacturers, and of course, there were lawsuits flying back and forth over the patent. As time went on, the other hearing aid manufacturers began to prepare to produce full digital hearing aids. In 1996, all of the major domestic and international hearing aid manufacturers formed a consortium and bought the patent from Washington University and Central Institute for the Deaf. Of course patents are valid for 17 years, so there's only another year left on the patent. So basically, the hearing aid manufacturers now own the patent. Our original patent applies to all programmable and all full digital hearing aids manufactured for another year. This is about half of the two million hearing aids sold annually in the US and at least as many sold internationally.
AO/Beck: Timing is everything! Sounds like you even beat Nicolet with their Phoenix project?
Popelka: Yes, we filed our patent and were building custom, low-power computer chips and put them in hearing aids quite a few years before their product came out.
AO/Beck: OK, well let's move forward to Everest Biomedical. When and where did that come from?
Popelka: The complete story of Everest probably begins in 1972. That was the first time I put a probe in a baby's ear. The idea was to learn about physiological measures related to audition, acoustic immittance measures, acoustic reflex measures and ABR in infants. I received a US-Israel BiNational Science Foundation grant and went to Israel and performed a lot of experiments involving neonates at that time and was already committed to developing better means for detecting hearing loss at birth. Then in 1980, I got sidetracked into the digital hearing aid effort. Once the digital hearing aid project was completed, around the early 1990s, I returned to the neonatal measurements. At that time I switched my grants from digital signal processing in hearing aids to otoacoustic emissions in neonates. In 1992, I won the Knud Terkildsen Research Fellowship and went to Denmark for half a year to work on basic science related to OAEs. Then it was back to St. Louis where I began writing research grants again with Bob Morley. Soon we were developing new technology and essentially taking big desktop measurement devices and making them very tiny. I and Bob Morley put in new grants to NIH and got them funded. After a few basic studies on neonates were completed, we developed digital signal processing technology for advanced OAE and ABR measurements in neonates. Through that process, I worked closely with Elvir Causevic and his brother, Eldar. Elvir was a doctoral student of Morley's in electrical engineering who was studying under Morley and me. He completed his doctorate this year. Eldar also received an electrical engineering degree from Washington University. So basically, Elvir and Eldar founded Everest Biomedical Instruments in 1996 and I have been involved with them ever since, joining them full time last year. We have hit (been funded) 100 percent of out grant applications and continue to conceive and develop innovative, and new biomedical instruments.
AO/Beck: What was the role of Everest from your vantage point at that time?
Popelka: Originally we wanted to develop the universal neonatal screening concept and we were committed to that well before the NIH Consensus statement was released. We believed that because hearing measurements in neonates are very difficult, and because there are simply not enough audiologists in the whole world to screen all the babies being born, we realized we needed to develop neonatal hearing screening equipment that was self-contained, easy to use, accurate and dependable for the screening process to succeed. Specifically, we were gearing up for developing tiny battery operated handheld devices yet with sophisticated super computers in them. That was why Everest was founded.
AO/Beck: And so the Everest Audio Screener was born.
Popelka: Yes, that's right. The Everest AUDIOcreener is indeed a screener, but it has the sophistication to provide some information previously available only in diagnostic, desktop equipment. Currently, AUDIOscreener can perform ABR and OAE, and later this year we'll be adding tympanometry, all in a hand held, battery-operated unit. Additionally, it has an infra-red interface so there is no need to hook it up to cables to print data or transfer results to another computer. The device is totally stand alone.
AO/Beck: Is this product available only through Everest?
Popelka: Right now that's correct, it is available only through Everest, but very quickly it'll be available through the usual distributors.
AO/Beck: Jerry, here's where the rubber meets the road...what does it cost?
Popelka: There are a number of configurations, An OAE alone unit is $4000.00, an ABR alone unit is $10,500.00, and the combined unit (OAE+ABR) is $14,500.00.
AO/Beck: What is the power supply for the unit?
Popelka: The power supply is a rechargeable battery that runs for 24 hours on a single charge. It also can be operated while the battery charger is plugged into the wall outlet.
AO/Beck: How long does it take an experienced person to perform an OAE after the unit is setup in the ear.
Popelka: About 10 to 12 seconds.
AO/Beck: Is this a pass/fail system?
Popelka: Yes, both the default OAE and ABR configurations produce a pass/fail result. We wanted the unit and software to be as simple as possible so non-audiologists could competently perform the basic screening.
AO/Beck: Is the OAE software based on distortion products or transients?
Popelka: Distortion product otoacoustic emissions.
AO/Beck: Do you anticipate that we'll see standards on DPOAEs in the near future?
Popelka: I sure hope so. I am pushing for standards on every front I can, for both OAE and ABR. People ask me all the time What is the sensitivity and specificity of the device? However, the question we need to focus on is....What is the sensitivity and specificity of the method or protocol? Our device can implement many different protocols, methods and criteria, and each will have an impact on the sensitivity and specificity. Currently, we have set the default screening criteria based on the NIH recommended parameters. The NIH study that determined these parameters was based on measurements of 7192 babies. That study was just published in October, 2000 in Ear and Hearing.
AO/Beck: What about getting the referral rates down? How do we go about that?
Popelka: The only way anyone can accomplish that at this time is to perform both ABR and OAE. In fact, that's what the large NIH, multi-center study recommended last October. The AUDIOscreener is the only handheld device that can implement the NIH-recommended procedure that includes both OAE and ABR.
AO/Beck: What about the ABR side of the unit - Is that screening only or combined screening and diagnostic?
Popelka: Screening, but it has key diagnostic features. The current unit can do both. For example, though the default setting produces an automated click ABR result, you also can choose tone bursts as the stimuli so you can really get a powerful ABR profile, based on the capabilities of the user. In other words, for both OAEs and for ABR you can use the screening mode that produces a Pass or a Refer result, or you can setup your own parameters to yield key diagnostic information, such as a series of waveforms in response to stimulus levels that sequentially decrease from 65 dB nHL in 5 dB steps so a threshold can be estimated as is done with diagnostic devices.
AO/Beck: Jerry, this sounds like another excellent product and once again, it appears that you're ahead of the curve! If the readers want to learn more about it, or discuss applications or protocols with you, how can they contact you?
Popelka: They can contact me via email at geraldp@everest-co.com, or they can visit our website at https://www.everest-co.com, or of course, they can feel free to use the toll-free phone number 1-866-662-8346.
AO/Beck: Thanks for your time Jerry. It's been a pleasure and I wish you success with the new venture.
Popelka: Thank you too, Doug.
