Interview with Mona Dworsack-Dodge, Wendy Crumley-Welsh, Jill Craig and Wendy Switalski, Otometrics
CAROLYN SMAKA: It's nice to talk to you all again! I'm looking forward to hearing about the new products from Otometrics. Mona, can you provide an overview of the new AURICAL HIT?
Mona Dworsack-Dodge
MONA DWORSACK-DODGE: It would be my pleasure. Last year we released the AURICAL, including audiometry and the FreeFit probe microphone measurement system. While that has been pretty successful, we didn't feel like the system would be complete until we released the Hearing Instrument Test (HIT) chamber. The main benefits of this are being able to perform real-ear-to-coupler difference (RECD) measurements and coupler-based fittings, as well as standard ANSI testing as we know it in the United States. We will be applying for FDA approval soon, and once we obtain that approval, the HIT will be available in the U.S. We are pretty proud of this little box because we have made some innovative changes to the way it is designed to improve the ergonomics and functionality for the people using it.
The test chamber is oriented vertically, so the hearing instrument is actually in the same position that it would be on the patient's ear when it is in the box (at least for BTEs). You can put the reference microphone close to the front microphone of hearing instrument and perform all the tests (including telecoil testing) without the need to reposition. Additionally, there are front and back speakers so you can do directionality testing.
In developing this system, we really wanted to try to do some things that make it easier for people to do the measurements. In a traditional test chamber, you tend to have to fight the fitting cables when closing the chamber lid and it is easy for the cables to become disconnected for the hearing aids to move when the cables are jostled. We have tried to eliminate that possibility as much as we can by using a memory foam seal to help secure things. Our hope is to make this process easier for people who are new to using this for coupler-based fittings and verifications.
SMAKA: All right. Stupid question, but because I have been out of the clinic for some time, how do you test receiver-in-the-canal (RIC) devices in the box?
DWORSACK-DODGE: In that case, you would take the acoustic putty and make a thin roll. You will use the HA1 or the ITE coupler, with the receiver placed in the open end. Wrap the receiver with the putty to secure it to the coupler, making sure there are no holes or gaps between the coupler and the receiver. Since the wire is not dampened by the skin of a user when it is tested in a coupler, it is also important to put a little mass on the wire to prevent feedback from wire oscillation. A small lump of acoustic putty shifts the resonance frequency of the wire to low frequencies where there will be no troublesome feedback.
One of the nice things with this system is that the adaptors actually snap off of the coupler. You don't have to screw anything on and off. Just place the instrument in the correct coupler adapter and snap it back on the coupler.
The Aurical HIT also has the ability to verify FM systems. There is an elevation plate that is designed to raise an FM transmitter up so that it's at the right location for the speaker. Then we have an external accessory box where you position coupler to measure the hearing aid. So the hearing aid is outside the box but still being measured in the coupler, with the FM is inside receiving the signal.
Aurical HIT setup for verification of FM system benefit.
SMAKA: And Mona, you worked on the development team for the HIT?
DWORSACK-DODGE: My colleague, Johannes Lantz was the primary development audiologist on this portion of the project. But I have been largely involved in the validation stage. I helped to work on the software interface for measuring RECD. One of the nice things about the system is that you can make the ear measurements binaurally, so it can happen pretty quickly. But the other nice thing is that when you make the coupler measurement, it is actually stored in the RECD probe. That means have more than one FreeFit device with RECD probes, they can all use that one HIT box. You take the coupler measurement with the RECD probe, and then go to another room and measure the ear. The software will read the values from the probe and calculate the RECD. So the patient and the HIT don't even have to be in the same place. This can work well for pediatrics, because it will also allow you to apply a single RECD value to both ears if you can only get one measurement from one ear.
Otometrics Aurical
SMAKA: Which I believe the research shows this is an acceptable practice with children, correct?
DWORSACK-DODGE: Yes, unless there's some surgical anomaly or known ear disease that make the ears anatomically very different. Another thing is that the software will record and save multiple RECD measurements. So you can go in and choose for individual ears which RECDs you want to use for the session. Maybe you only got one RECD on one ear one day and a different one on another day.
SMAKA: Excellent. Tell me about the validations that you do.
DWORSACK-DODGE: Sure. We do both internal and external validations. We have our own audiologist doing validations internally to make sure that we have covered things from a training perspective that might present challenges for people. We also do formal validation at user sites such as hospitals or dispenser shops. We have done validation in the United Kingdom and in Canada for the Aurical HIT system. It will be released in the rest of the world first, and then we have to wait for FDA approval in the United States.
SMAKA: So do you look at people fitting RECD?
DWORSACK-DODGE: Yes. We incorporate test sites that are using RECD on a routine basis. We try to go to people who we know are experts in a particular area when we're doing validation.
SMAKA: Then is there still time in the validation process to go back and make changes?
DWORSACK-DODGE: Yes. In fact, when we initiated the validation process of HIT, we identified some things that could potentially cause some confusion for users, and some suggestions were incorporated into the final product. You and I talked last year about the change in our development process, and now we are able to adapt to user feedback more rapidly. This is part of that, and it's really nice.
SMAKA: I know you can't say exactly, but how long do you think it should take for the FDA approval before this is available in the US?
DWORSACK-DODGE: Normally the FDA says that they have 90 days to give an answer. So in 90 days you can have the approval, or it can come to the 90th day and they come back and say you need to make changes. We are hoping for a quick decision.
SMAKA: Thanks so much, Mona. Wendy, can you tell me about the new ICS AirCal?
Wendy Crumley-Welsh
Wendy Crumley-Welsh: The ICS AirCal is our new air irrigator. It's the replacement for the NCA-200, but is still as precise and as accurate as the NCA-200. We released the irrigator head itself about a year-and-a-half ago, and we made it available on newerNCA-200 systems. We had many things to consider when developing the new delivery head such as the flow and speed of air coming out of the irrigator and the distance of the irrigator from the tympanic membrane. All of these things have to be very accurate. You can't have a large volume, because you won't get the same type of stimulation when you do the caloric irrigation. The nice thing about this delivery head is that it is like looking through an otoscope. You can easily see the tympanic membrane, and that's of utmost importance when doing air irrigation, because you need to make sure that airstream is going down to the eardrum and not hitting the canal wall or reflecting off cerumen.
Otometrics ICS AirCal caloric irrigation device.
When we moved to the ICS AirCal, we had perfected the irrigation head, and now we were building the main unit. We went back and evaluated customer requests, sales representative requests, and then also at our complaint log to see what was breaking down or what most people were having difficulty with. The one thing that people forget about an air irrigator is that if the system is expected to give you comparable responses to a water irrigator, it must cool the air below room temperature. For it to be able to do that, you actually need to have water cooling the air. The water actually travels over peltier wafers and cools the air so that the air can reach 24 degrees, which is what the NCA-200 did. When I looked at the complaint logs, the biggest problem was that people forgot there is water in an air irrigator and they didn't do anything about it until it the unit overheated.
So on the ICS AirCal, we added a nice LED display. We also added a view of the water level, so the user can see if the water level is too low. It turns orange when it's time to refill. Refilling was made much easier, you remove a small cover to refill the water rather than taking the whole case off the unit, which is how the NCA-200 was. This has made refilling easier, but really, it has made people aware that they need to refill it about once a year.
Other than that, the display is very intuitive. We wanted to make sure that it was easy not only to use with our products, but for anyone even if they use competitor VNG/ENG equipment,. When used with our Chartr200 VNG/ENG, there's a cable that links the two together, so everything is integrated. When you push the foot pedal or trigger button on the delivery head, it automatically starts the tracings and the countdown timer. You know, as an audiologist, you work so hard to get the head positioned at the right angle with the irrigator pointed right at the tympanic membrane. You push the button, and immediately, what do you want to do? You want to turn around and look at the main unit to see if the countdown timer has started. So one of our sales guys said, "Wouldn't it be nice if the light flashed so you can tell that the timer started and you don't have to take your eye off the ear?" So now the light in the delivery head flashes to tell you it communicated with the main unit.
We also made the beep indicator adjustable in volume. Once the countdown timer gets to zero, it beeps to let you know you can stop irrigating. However, we have come to realize that some clinicians arehearing impaired or their environment is noisy and they were not always hearing that audible alert. So now you can make that beep louder or softer, depending on your preference.
Another thing that we worked on for the ICS AirCal was ensuring that the unit itself was quiet. Irrigators on the market today are kind of noisy. Not only did you have the noise of the airflow, but there was residual noise of the air pump and the water pump working at the same time. So now we house the air pump. That took a lot of time to get a sound-proof housing in there while still keeping it lightweight. This unit is only 18 pounds with water that is 20 pounds less than the NCA-200.
SMAKA: Wow.
CRUMLEY-WELSH: Because you are tasking the patient, they need to be able to hear you. Typically, these patients have hearing loss and tinnitus, and they don't have their hearing aid in during testing. Do you really need more competing noise to talk over? We wanted to make sure that we addressed this issue. And we did, beautifully.
After listening to our customers and sales people, we changed even small things that make the ICS AirCal more user friendly. The NCA-200 didn't have a safe place to store the delivery head, so our sales people would Velcro and stick it on the top of the machine. After seeing that, we made a cradle for the delivery head, and it can be situated in almost any configuration, left or right side and positioned if you want the irrigator at the edge or sitting back on the table..
SMAKA: We get so many requests for vestibular courses. It's important to remind our readers about the Otometrics courses on AudiologyOnline.
CRUMLEY-WELSH: Right, our courses are also listed on the Otometrics Web Channel. In addition, when we were launching the ICS AirCal, I asked Dr. Kamran Barin, who does a lot of consulting with us, to make three short videos for me just for the air irrigator. One is on why positioning the patient at 30-degrees is important. One is on why tasking is important. And the other, he discussed the research documenting that air and water are comparable if the proper settings are used. All of those videos are available on www.otometrics.com under Chartr 200 and AirCal.
SMAKA: Thanks, Wendy. Jill, what's new with Otometrics in terms of Evoked Potentials (EP)?
JILL CRAIG: We just released new software, version 7.2, and we added some small features to make it a little bit more user friendly. Nothing major, but things like a shaded normative area where you can actually bring a quick pop-up on the screen that highlights where waves I, III, and V should be. For example, you can click on a wave form that you've collected and it will bring up where those peaks should be. Then you know approximately where to mark. So instead of marking the waves and clicking several times you can just click once.
Jill Craig
We have also moved the display gains around to make them more available to you when you are collecting data. They're now at the top toolbar so you can quickly do an increase and decrease of the display. That makes it a little easier, a little faster, and fewer mouse clicks. For our international customers we've added a normalized asymmetry ratio for VEMP.
The goal when we do ABR is to do things as quickly as we can. We don't have a lot of time, so we have to be efficient and we need to get the patient in and out as fast as possible. Time is money, so we have to do things quickly.
One that has always been unique to our system is the remote control, which keeps the testing patient-centered. You can be next to your patient, whether that is soothing a baby or keeping an adult calm, and you can start, stop, and reset with a click of the remote control. I think it is a really nice feature.
Another nice feature that we offer is a PediGram, where you can actually run tonebursts and then plot the wave V thresholds on an audiogram. You can even print that audiogram out.
SMAKA: Does it convert it from nHL to eHL?
CRAIG: You will see it in an audiogram-like feature, but it's still within the ABR so it is plotted in nHL.
There are some training videos on our Web site, and we're going to add some troubleshooting videos. We continue to try and provide educational materials online for our users
The CHARTR EP200 is full two-channel system with ABR, MLR and ALR. You can, of course, run it as a one-channel system if you prefer. We do have electrode switching that can be enabled for use with three electrodes instead of four. P300 is also an available option as well as ASSR
SMAKA: Thanks, Jill. Wendy, I've heard you speak recently about best practices.
Wendy Switalski
WENDY SWITALSKI: Yes, it's an important topic. I think never before have we had the challenges that we have now in maintaining or protecting our scope of practice. Right now we see so many changes to the marketplace. I think that those changes provide us with an amazing opportunity to truly show what audiologists do which is provide audiological care, not just sell product. It pushes us to evaluate our processes, and to then be able to justify our role in the process. We have looked at research and market trends to identify some of those processes that are important.
SMAKA: For example?
SWITALSKI: Probe microphone measurements, validation and verification measures. I think that sometimes audiologists look at best practices as a static, boring policy document, and it's not. They are defined as best practices because they truly provide excellence in care for the patients. I think we have to really look at that and realize that they are not a hindrance to your day. They are what your day should be.
SMAKA: Well, when you look at the flipside of it, if you don't have best practices and you don't have the best outcome, what do you have? More frequent return visits from the patient.
SWITALSKI: Absolutely.
SMAKA: You lose patients this way. They will go somewhere else if they are unhappy or look for something online that's cheaper. Well, why are they unhappy?
SWITALSKI: Or most concerning, what about the ones that stop using hearing aids all together? A new user will wait about seven years from the time they notice a problem to doing something about it. But what about the people who have done something about it, but are inadequately treated or are less-than-satisfied? How long do they wait? I think it's longer than seven years. If we are going to do it, we have one shot to change that person's life.
The AURICAL system has been so well received in the marketplace because it's provided a platform that's truly easy to implement into a clinical workflow. I've had the privilege of working with highly-skilled and caring professionals who knew they wanted to add something to their fitting process, but weren't sure how. Some of the customization that we've done with the FreeFit have allowed us to plug that into their process. You can take people who never used probe mic measures before to people who now can't live without it and share the stories all along the way of what it's done for their patients. I personally have experienced that.
Now we have a system that allows us to add additional quality measures to make sure that the hearing aids are functioning the way they should be, both for adult and now pediatric users.
Mona already talked to you about some of the extremely unique features. It's a very exciting product. They've done great work.
SMAKA: It's been nice to catch up with you as usual and to see all the new products you've been working on at Otometrics. Thank you for all your time!
For more information about Otometrics, visit www.otometrics.com or the Otometrics web channel on AudiologyOnline.
