For at least three decades, the idea of being able to place a “magic wand” into a patient’s ear, press a button, and get a 3D virtual impression of the ear canal has been the stuff of dispensers’ dreams. Impression-taking techniques that result in a highly accurate replica of the ear canal remain a major obstacle in hearing aid fitting. In fact, the number of pages that HR has dedicated to the impression-taking process—often thought of as more of an art than a science—could fill a good-size textbook.
Thus, when 3DM Systems, Lantos Technologies, and 3Shape introduced the world’s first 3D ear canal scanners at this year’s American Academy of Audiology (AAA) convention in Boston, it created quite a stir. Crowds of audiologists lined the companies’ booths to see their demonstrations. After the dust had settled, the Academy voted 3DM as the “Best New Product,” and it described 3DM, which is short for “Three Dimensional Measurement,” as the “world’s only noninvasive in-ear 3D scanner for the digital design and precise production of custom hearing aids and earmolds.”
3DM Systems (formerly known as ShapeStart), Atlanta, was founded in 2008 by brothers Karol (Karl) and George Hatzilias. With a strong background in 3D technology at Georgia Tech and with initial funding from the Department of Defense, the Hatzilias brothers’ initial challenge was to take a large-scale scanning technology—designed for everything from scanning the hull of a 747 aircraft to components on the space shuttle—and scale it down for niche market applications that require precise tolerances. Their first attempts at an ear canal scanner reportedly involved an inflatable membrane, similar to the Lantos Technology system that involves inflating a “balloon” inside the ear canal with a water-dye solution and then scanning the balloon’s contour.
However, in 2009, the two brothers settled on what they believe is a more noninvasive solution that uses a super-wide-angle otoscope and a precision scanning device, eliminating the need for the “balloon.” The accuracy of the scanner is within 50 microns, or about half the thickness of a sheet of paper, and the company is working on a combination of systems in which tolerances may be reduced to as little as 10 microns, or about one-seventh the diameter of a human hair.
During the AAA Expo, HR interviewed the president and CEO of 3DM Systems, Wess “Eric” Sharpe, who developed the business model and led the company to market. Among other initiatives, Sharpe also led the development of 3DM’s powerful software and analytics with proven methodologies such as Six Sigma, a process for improving quality by identifying and removing the causes of defects and minimizing variability in manufacturing and business processes. Also participating in the interview were company chairman Sam Kellett and board member Michael Andreozzi, president and CEO of Beltone New England, one of the nation’s largest privately owned dispensing networks.
HR: Can you give us a general overview of your business model, as well as a summary of how the system works?
Eric Sharpe: Our business model is fairly straightforward. We provide the scanning system and a new high-end computer with pre-loaded software. The system has three major components: the scope mode, the 3D scan mode, and the probe mode for tissue measurement. All of the 3DM functions are designed for easy use and also offer advanced features, such as video and scan editing capabilities, Six Sigma analytics for the production processes, and highly intuitive business analytics with operational benchmarking at no charge.
The scope mode is a high-definition (HD) video otoscope that provides a super-wide-angle video of the ear canal. As far as we know, the 3DM video otoscope is the only VO that provides HD video, and it offers nearly twice the field of view of other scopes on the market. The scan mode enables precise digital scanning of the ear canal, tympanic membrane, and outer-ear parts such as the concha, helix lock, tragus, antitragus, etc. To ensure the best possible fit, the probe mode measures tissue displacement for optimizing the seal and comfort of the final product.
When clinicians obtain our system, they receive the entire [scope-scan-probe] package, the analytics software, technical support, and a computer with a LCD flatscreen. They pay nothing up front; there’s no charge for the standard equipment. They enter into a 3-year agreement with 3DM that allows the continued use of silicone impressions; however, if your scan is digital, then it must be done with 3DM. Despite very little marketing, we already enjoy interest from all over the globe and have well over 20% of our target US market committed to 3DM.
To obtain a 3D scan, you’re guided by our user-friendly software through the completion of the three modes and then simply hit “send.” At that point, the data goes to our computers for post-processing. About 10 to 15 minutes later, it arrives at the hearing instrument manufacturer or lab for hearing aid or earmold production. From there, the manufacturing process is significantly improved by the 3DM Six Sigma methodology, and the manufacturer or lab creates the product on their screen, prints the mold, assembles the parts, and ships it back to the clinician.
When the product comes back to the dispensing professional, there is a procedure for entering data about the fitting back into the system, so that a self-learning or corrective intelligence application can use the information to continually improve specific fittings. To ensure that our product and processes enable the highest value with minimal change, we have worked with over 100 clinicians in developing the 3DM systems.
HR: The hearing industry is relatively small and the ear canal has always posed its share of problems for industry entrants. So, I’m guessing it was no small feat to develop a device small enough to scan the ear canal?
Sam Kellett: You’re right. But, although the US hearing aid market totaled 2.8 million net units in 2011, we estimate there will be about 4.3 million ear impressions in 2012 due to the additional ear impressions required by earmold remakes for existing users. From a global perspective, the market is approximately 3 to 4 times that size or about 14 to 17 million scans annually. Moreover, our research suggests that adoption of hearing aids will grow rapidly as 3DM enables far better comfort and seal for deep-fitting hearing aids.
Regarding the technological obstacles, we’ve joked that digital scanning of the ear canal represents a problem on the level of trying to fit a tuxedo on a mosquito. We think Karl [Hatzilias] is probably one of very few people in the world who could have figured out how to develop the micro scanner. It’s an extremely difficult technology to develop, and this is borne out by the fact that companies with R&D budgets in the tens of millions of dollars and a cadre of very smart engineers were not pursuing it. The solution requires deep interdisciplinary expertise.
HR: So, as an audiologist or hearing instrument specialist, what’s the typical procedure one follows in capturing a 3D ear canal scan?
Sharpe: First, the clinician lets the software know the location of the ear canal aperture by tapping the first curve with the probe. That’s all you do: simply touch the aperture. From there, you go into video otoscope mode. We automatically show the canal depth with the probe depth on the screen. As soon as you get past the second bend of the canal and the laser registers the tympanic membrane (TM), it provides the actual canal distance. So, if the patient is a child, it might read 14 mm, and if an adult it might read 27 mm. The advantage here is that you always know where you’re at in the ear canal, making this a great safety feature. In scope mode, you can record HD video and take photos of whatever you wish.
The clinician then moves to the closed-mouth scan mode and obtains the scan. From there, they go to the open-mouth scan mode with the bite blocks and again obtain a scan. Each has a target time of about 45 to 60 seconds.
Once you have the closed- and open-mouth scans, you can move on to the acquisition of tissue displacement data. In this case, you simply enter the make and model of the hearing aid and the system will specify the target area for analysis. The system sets the amount of force you’ll need to apply with the probe to get the displacement [in microns] for the canal, tragus, and antitragus. The entire process is guided and takes 5 to 10 seconds to acquire since the clinician is just lightly touching these areas.
So although we’re gaining a lot of information from the ear canal, it’s a very speedy process for the clinician. Basically, you insert the probe into the proper place along the ear canal; take the open and closed scans; tap the canal, tragus, and antitragus; and you’re done. Once this is complete, you can add voice, video, or text to any given file. It’s far faster. It’s far safer. It’s far more accurate. It’s less expensive. It gathers a massive amount of critical information. It will produce a far better product. It will enable higher levels of hearing aid adoption. In sum, it’s a game-changer.
HR: How do you charge for the system?
Sharpe: We will charge per scan and require a minimum average number of scans each month. For an earmold, we’re charging a total of $7, which breaks down as $4 for the clinician and $3 for the lab. For a hearing aid shell, we’re charging $12, which breaks down as $4 to the clinician and $8 to the manufacturer. We require a minimum of 15 scans per month but that’s total scans. Since roughly 80% of patients need two scans with a binaural fitting, that is only 6 to 7 patients per month. That pricing translates into less than ½ of 1% of the average hearing aid price, which is a great deal given the high impact value provided by 3DM. There are no special deals, no special favors; the value is undeniable.
HR: When will it be available to dispensing professionals?
Sharpe: If everything stays on track, we believe that it will be ready this fall on a first-come, first-served basis. It has taken years of time, thousands of man-hours, and millions of dollars to get to this point, and we will make sure that we deliver the best possible system to clinicians around the globe.
While we will have a commercially viable system ready in about 60 days, we have decided to upgrade a few components in order to ensure the diffusion of innovation and rapid adoption. The 3DM system is a powerful tool for clinicians, as well as an extremely important platform for the industry at large, and a month or so of more time will not stand in our way of delivering the best system possible.
HR: From a dispensing standpoint, what do you think are the most exciting things about this technology?
Michael Andreozzi: I think one of the greatest advantages is that we can now build amazing consistency into our products. We’re gathering so much more information on both the ears and the particular models of hearing instruments [and how they articulate with the ear canal], along with end-results from the patients on comfort and fit—all of which gets fed back into the Six Sigma technology process. That process will provide hearing aid manufacturers with the information needed to eliminate production cost and time while reducing returns. So for any given hearing aid, we’ll have so much data that inaccuracy will become a thing of the past. We’ve never had this depth of information before.
Sharpe: And it’s not just a matter of using this data to reduce remakes. Certainly, reducing returns [with a historic return-for-credit rate of around 20%] would decrease manufacturers’ costs significantly—and we are obviously interested in this. But I think what’s more important is making a far superior product for the consumer. If we can achieve this together [with the help of manufacturers], more consumers will tell other consumers who need hearing help. We’ll have more consumers saying, “I really like this hearing aid: it’s comfortable, it doesn’t walk itself out of my ear, it doesn’t create feedback, the sound quality is great and more natural, etc.” That’s the ultimate goal. Based on what we see, both anecdotally and from MarkeTrak, the 3DM technology will bring about high-impact-value for every customer, and increase market growth while reducing returns.
HR: Can you give us an example of what types of new or enhanced information will be available from this system? How will it make fittings better or more comfortable?
Sharpe: Although it’s a completely new area for research and development, I think tissue measurements in different regions of the ear canal may be an important statistical variable. In any ear canal, you have the bone and the fatty tissue that make up the canal walls, and these areas have different levels of elasticity [firmness] and dynamic movement. So, this is a major new element for our scanner to measure.
The software allows the clinician to see exactly where they need to be with the probe and how much force to apply in the canal and other areas when measuring tissue displacement. So, for example, the test area might be 5 mm into the canal with a 1 mm tolerance in either direction. So the clinician with the Otoscan is guided by the intuitive software—which uses a green and red system for precisely locating the probe—and it will not capture data unless the probe is in that green area, which is exactly where the hearing aid will be seated and, thus, the correct area to test.
The 3DM analytics system calculates patient factors such as age, gender, height, weight, hearing loss, and feedback scores for each specific class, brand, and model of hearing aid. The system calculates the optimal test area followed by a precise measurement of displacement in the exact area affected by the hearing aid.
I should note that, with a balloon-type system, you are averaging displacement over the entire length of the ear canal rather than the optimal area. And while this may provide you with some useful data, the balloon system cannot offer information on any one specific area. Instead, it will always be stuck with testing overall canal displacement. However, a hearing aid isn’t fit in the entire canal; instead, it is located in a very specific region depending on if it’s an IIC, CIC, ITC, ITE, Lyric, etc.
With the 3DM system, we can measure the specific region where the hearing aid will be located using data from manufacturers’ specific brands, makes, and models of hearing aids. We then use a systematized version of Six Sigma processes called DMAIC [Define, Measure, Analyze, Improve, and Control] for comparing the data in a fashion that results in optimal fittings. Each one of the system components has many, many subcomponents that I won’t go into, but the point is that all this information is highly correlated and analyzed, allowing us to “dial in” the best possible fitting via a vast array of data collected before, during, and after each scan. This process is not theoretical; it is proven.
HR: Potentially, this amounts to a lot of fairly valuable information about specific products in a very competitive marketplace. From the manufacturer’s standpoint, how will you be managing this data?
Sharpe: We have been around the block enough times to know what an industry standard looks like, and 3DM is just that. Because we fully expect the product to be ubiquitous throughout the industry, we believe that 3DM will become an information hub that represents a huge opportunity. We see this as an incredibly important future gateway into the hearing aid space, and we see the system’s adoption—from which we’re already collecting and using a lot of information—as a major step forward in terms of how product processes and quality fittings can be improved.
However, to ensure that the industry is comfortable with us managing all this information, the data will be stored by a dedicated, secure, third-party provider that is a known data-management company. Most importantly, the contract with that data-management company is not just with 3DM; it will be with every 3DM customer. So, the contract will state that we will never own or even have access to the data. While 3DM will control the algorithms for optimizing the comfort and seal of hearing aids, 3DM and/or any other company will never be able to look at any specific clinician or manufacturer data. That data will forever remain the property of the specific clinician, lab, and/or manufacturer.
HR: Will there be separate models for the hearing aid dispensing, hearing protection, and retail earbud markets?
Sharpe: Yes. For the hearing protection customizations, we are developing a franchise model for industrial and personal hearing protection while working with the US and NATO military forces directly for combat hearing protection. Regarding retail earbud customization, we are working on a big-box retail distribution model coupled with the development of safety technology that would help with hearing protection therein. While we will pursue those opportunities, the scanner used for those markets will not be capable of producing hearing aid customization.
HR: Do you think your system will make it easier for dispensing professionals to supply information about the ear canal past the second bend, as in the case of deep-fitting CICs?
Kellett: Absolutely. You’re going from a fairly invasive system of injecting material into the ear canal (while relying on an otoblock to stop the silicone), to a system that is essentially no more invasive than an otoscopic examination that nearly all dispensing professionals are very comfortable doing. 3DM scans the canal and TM with complete accuracy while scanning the entire outer ear as well. In contrast, with a balloon system, the scanner is being mechanically retracted out of the ear and it really cannot stop and look at some key areas because it’s restricted to a lateral retraction. In other words, lateral retraction compromises the angle of incidence and, thus, compromises concha and helix lock scanning.
Andreozzi: We think that, with 3DM’s technology, you might see the CIC and micro-CIC market really gain ground because we can now capture data beyond the second bend and provide deep-canal fittings—or at least make it so that the impression-taking process is no longer a barrier to deep-fitting instruments.
Additionally, in a multi-office dispensing practice such as mine where we have more than 100 audiologists and dispensing professionals working at many locations, there is a certain amount of liability for the business owner associated with the impression-taking process. I know there are many otherwise excellent, conscientious practitioners throughout the country who are simply nervous about going deep into the ear canal with impression material. And, as a practice owner and manager, I’m very reluctant to ask someone to do a procedure they’re uncomfortable with due to liability issues. Blow-by [silicone material moving around an improperly placed otoblock] may be rare, but we all know that it can and does happen. The 3DM technology eliminates that problem while clearly improving the process and customer satisfaction.
HR: What do you think the industry will get out of this that we didn’t have before?
Sharpe: I think the real key is delivering a better, more consistent product and service. That means happier patients and clinicians. It also means fewer remakes, fewer returns, and lower distribution costs. And hopefully the industry sees a greater acceptance of hearing aids and a larger, faster-growing market. My research and analysis leads me to firmly believe that a significant amount of sales growth via higher adoption rates is available and that the 3DM technology is the path to realization of such growth.
Another important element is the analytics that will help manufacturers market and operate far more efficiently and allow them to analyze their entire pipeline in real-time. They will literally be able to change recommendations and specifications as they see the data come in. With that information, the manufacturer will be able to optimize the development, marketing, and production of specific models far faster and more effectively than in the past. That’s the kind of valuable data and insights that are not available today until much later in the product cycle.