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Interview with Gora Ganguli, President, VitaSound

Gora Ganguli

November 5, 2007
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Topic: Instant Custom-Fit Earpiece Technology
Dr. Paul Dybala: Hello, this is Dr. Paul Dybala with Audiology Online, I am speaking today, with Gora Ganguli, who is the President of VitaSound. Gora, welcome!

Gora Ganguli: Pleasure to talk to you, Paul, and I look forward to introducing our company to your audience.

Dybala: Absolutely. I do quite a few interviews, and usually I'm talking about established companies with new products or sometimes established companies with established products. This is kind of exciting for me today because yours is a new company with a relatively new, innovative product to the hearing aid industry.

Just to start things off, Gora, could you give us a little bit of your professional background, as well as some information on VitaSound?

Ganguli: Sure. Well, I've been in the microelectronics industry for over 25 years, most of that with IBM, and also with Gennum Corporation, which is probably familiar to your audience, for the last eight-and-a-half years or so. I used to manage the audio and wireless division, which was an extension of what was originally the hearing instrument division at Gennum, producing DSPs and other solutions for the hearing industry.

So that was sort of my introduction and experience in the hearing business, and during that period I was also on the board of directors of the Hearing Industry Association and BHI, the Better Hearing Institute. I would say I have been immersed in the hearing industry for at least the last nine years.

I joined VitaSound this year. Actually, VitaSound is a subsidiary company of Sonomax Hearing Healthcare, and Sonomax has been around for about seven to almost ten years now, if you include all the development that's gone on. Sonomax's business was really based around instant, custom-fit technology associated with hearing protection.

As your audience probably knows, hearing protection today is largely based on throw-away foam earplugs as well as the ear muff style of protectors.

The Sonomax company introduced a new technology that not only custom fits the ear with an ear protector but also includes a patented technology by which the actual noise attenuation can be measured.

In other words, a microphone is inserted through the earplug into the ear and the individual is then exposed to various noises in the environment. Then the attenuation is measured so that we can certify that the plug is actually providing X amount of dB noise attenuation. As you might imagine, this kind of product targeted towards the industrial sector would be very valuable for employers as a way to ensure that the ear protection is adequate for their employees. That's the basis of the technology.

Over the last couple of years Sonomax has been looking at how to take that technology into other markets. As the market for ear-level devices continues to grow quite dramatically, especially with MP3 players, Bluetooth cell phone headsets and other devices where lots of people are walking around with things in their ear, the whole notion of the custom-fit product looks quite attractive. The objective of Sonomax was to develop a consumer-based business around that core technology, and that's why I joined them. Essentially, my role in running this VitaSound company is to develop the consumer-products business of Sonomax.

Dybala: Could you go into more detail on the custom fit technology itself and how a professional would be using it in his or her office with patients?

Ganguli: The best way to describe the fundamentals of the technology is if you can imagine something in two layers, like a tire or an air mattress with an inner layer and outer layer.

Basically it's an inflatable device. It's got an inner shell and an outer skin around the shell, and both of the layers are made of the same material. It's a very comfortable and soft material that moves with the movement of the jaw and the changing shape of the ear canal. What we do to make it a custom fit is inject, through a valve, much like you would inflate a tire through a valve, a two-part proprietary silicone mixture.

The injection is done outside of the ear. There's a prescribed amount to inject, that Sonomax has determined after fitting thousands of people, that tells exactly how much to put into the earpiece.

Once the two-part silicone is injected into the shell, between the two walls, it is then hand-massaged, if you will, to distribute the mixture throughout the earpiece. Then it is placed in the ear, and the individual just has to hold it in place for about 2 minutes to allow it to set. It takes about another minute to fully form, but in 2 minutes it takes the shape of the ear canal.

There's no otoblock; there's no material that has to be put in the ear to make an earmold impression. It's actually far less traumatic for an individual to get fitted with this, because no liquid, no material actually touches inside their ear. As I said, in 3 minutes you have a fully custom-fit device the person can walk away with. This is the basic concept of the technology.

When we looked at this with Sonomax, in my previous role at Gennum, we looked at this shell technology and thought, "Is there a way to put a standard electronic module into this instant, custom shell, and convert a passive hearing protection device into some active device?"

Dybala: An instant-fit hearing aid.

Ganguli: Correct. The hearing-aid device that we came up with is the one that is in the process of being launched in the market. It's a very small inner module which resembles a thinned out ITE device, if you will, and contains the typical electronics of a hearing aid. It's a stand-alone device. Every single hearing aid that we make, regardless of the individual who uses it, has the same identical inner module.

So the internal electronic housings can be made fundamentally as a cookie-cutter type of process. There's no special custom work that needs to be done in manufacturing as it is a standard size.

We connect the inner module with the outer shell using a retaining ring that's snapped onto the device and holds everything in place. Presto, you have a custom hearing aid that took all of two minutes to fit to the individual.

Dybala: Wow. So, if I have someone in my office, I essentially have multiple shells and multiple electronic modules that snap together. It makes it really easy if I need to remake a hearing aid or, I'm even thinking, if something changes in the ear canal. It's relatively simple for them to come back in and essentially create a whole new hearing aid, correct?

Ganguli: Right. It's something that can basically be assembled and disassembled quite easily. That's really attractive to the opportunity of the hearing aid market. Think of it from the perspective of somebody who comes in for a hearing aid and would like a custom aid, as opposed to a behind-the-ear type of technology.

Today you would have to make a custom earmold, send the impression off to the factory, get the hearing aid built, and wait for the return of the aid and for the patient to come back in and actually try it. Here we have a technology where any good hearing aid, with a variety of features and functions, could be kept in inventory at the audiologist's fingertips. Then, when the patient comes in, they can be immediately fitted with this and get an immediate view of how well the hearing aid works.

Now, in the case of someone who says they don't like the hearing aid, or is not interested in purchasing the aid, all we do is remove the inner hearing aid module and throw away the external custom-fitted shell, which is not an expensive piece, relatively speaking. So it allows us to not have to break open a custom hearing aid that's built at the factory to recover the electronics. We think that this could fundamentally be quite an economical delivery process for hearing aids.

There are other advantages, as well. Let's say the electronics fail inside the hearing aid module, but the outer shell is still fine. The person has to come in, and with today's technology, the hearing aid would have to be sent back to the factory for repair. Here, the audiologist can simply remove the non-functioning hearing aid unit, replace it with a functioning one, reprogram it and send the person out immediately with their hearing aid, with no waiting time involved.

Other things can happen, of course, like the outer shell getting chewed by the dog [laughs]. The inner electronics are still fine, so all you have to do is replace that outer shell with a new custom shell and all the electronics in the inner module are still fine. From a cost perspective, we think that this could have some significant benefits, as well as the timeliness of delivering hearing solutions to people so they can appreciate the benefits of hearing correction on the spot.

Dybala: This all sounds great, but are these instant fit devices comfortable? Comfortable to wear all day long?

Ganguli: Absolutely. This same technology has been used to develop hearing protection devices for persons who are wearing them in a factory environment and are using that ear protection eight to ten hours a day. These are generally people who don't wear hearing aids. They're not accustomed to having a device in their ear, so it has to be comfortable enough to pass that test, as well.

The material itself is very good to avoid the kinds of issues that you would have with a hard shell. And in the event that something went wrong, in terms of the actual fitting process, it's a relatively simple thing just to throw away that shell and give them another one. From the experience the company's had with dispensing, it's very rare that a shell has to be remade. In fact, the error rate for a perfect fit is less than 3%, which is considerably better than competing technologies.

Dybala: Can you expand more on the kind of development and testing that this type of shell material has gone through?

Ganguli: Sure. Obviously, the rules and regulations associated with industrial hearing safety and hearing protection, OSHA standards and so on, are quite stringent. The materials have to be qualified and approved. And these are all bio-compatible materials, tested for skin reactions and proven for comfort and safety associated with the materials, as well as the function. Both the skin material and the fillers are rated implantable medical grade, which is obviously more than what is required for our applications.

In other words, when a device like this is dispensed in the industrial environment, there's a noise reduction rating factor that has to be assigned to the fit. So it is a very regulated and controlled industry as well, because we're talking about the industrial environment. And in that industrial environment, tens of thousands of fittings have been done. Just to give you an idea, the largest distributor of hearing protection in the industry is a company called Aearo. Aearo is a US-based company that is a dominant player in industrial hearing protection. In fact, just as a side note for you, they actually are the only company in the world that has a patent on a color. [laughs]

Dybala: Yellow?

Ganguli: Yes, yellow. [laughs]

Dybala: I didn't know that. That's interesting.

Ganguli: Aearo is a distributor of the Sonomax technology. And Sonomax has distribution relationships with hearing protection companies all over the world. So really, the technology's been proven in tens of thousands of ears throughout the world.

Dybala: Well, I had one other quick question for you, before we wrap up. You talked about how one of VitaSound's goals is to look at any sort of consumer product and apply its technology. You mention moving beyond hearing aids correct?

Ganguli: Yes, absolutely. The hearing aid was the first area that we addressed. With the astonishing growth of Bluetooth cell phone headsets and MP3 players, and especially with the iPod revolution, these are also extremely attractive markets. And there again, with the amount of use people are putting those things through today, the sheer number of hours in a day, comfort and fit become essential.

The other thing worth mentioning is that custom fit earphones provide a significant level of isolation from environmental noise and prevent sound leakage from the ear. This means that you generally end up listening to the music at a much lower volume than with non-custom earphones - an enjoyable but safer listening experience.

Dybala: Right.

Ganguli: And so, we thought that this would be the ideal time to launch products into the consumer markets and we have recently launched products for both MP3 players as well as for cell phone headsets.

If you take a typical cell phone headset and you apply this custom earpiece to it, the user experience dramatically improves, not to mention the comfort and the secure fit. This applies to the MP3 products as well.

So, as with the hearing aids, the MP3 player earphone has a high-quality receiver that sits inside the little sub-module and is a standard product that's provided to a dispenser. Then, when somebody comes in for custom earphones for an MP3 device, the dispenser only has to build that custom-fit outer shell and simply pop in the inner module.

So, conceivably, it could expand the business of custom-fitted products for audiologists and dispensers in the hearing market to extend into the consumer space of MP3 player earphones as well as Bluetooth headset earphones, and so on.

Dybala: You can provide an instant-fit custom hearing solution for patients who have hearing loss or who have normal hearing alike.

Ganguli: Exactly!

Dybala: Well, I will be looking forward to seeing how far you can go with this technology; it looks to be very interesting. Gora, thank you so much for taking time to visit with me today. If anyone wants additional information, you can go to the VitaSound Web Channel on Audiology Online, or you can also go to their Web site directly at vitasound.org or sonomax.com and read more about the technology and products there. Gora, thanks again!

Ganguli: Thanks for the opportunity to talk to you, and I'm looking forward to communicating further with your audience in the future.
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Gora Ganguli

President, VitaSound



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