Approaching single-sided deafness with an innovative new product.
Daniel R. Schumaier, PhD, president of Ear Technology Corporation, Johnson City, Tenn, is a dispensing audiologist with three offices in northeast Tennessee, and an industrial hearing conservation service with clients in 14 states. An entrepreneur at heart, Schumaier is the inventor of Dry & Store® and TransEar®, holding numerous patents, both domestic and foreign. Schumaier recently spoke with Hearing Products Report about TransEar.
HPR: Tell us about your latest product, TransEar.
Schumaier Over the years, I’ve seen quite a few patients with unilateral hearing loss, and like many audiologists in the same situation, I was frustrated by the challenge of fitting them with an effective, comfortable, and affordable remedy. The few offerings available involved either a CROS hearing aid that occluded the good ear, high-powered CICs, or bone-conduction devices involving either a bulky headband or a surgical implant. I thought, “There’s got to be a better way.” The solution that I came up with is quite simple, yet it had not been explored previously. I applied for and was awarded a patent for a bone conduction hearing aid that capitalizes on the fact that it’s possible to achieve bone conduction via the osseous portion of the ear canal. TransEar was approved by the FDA for marketing and distribution in 2005.
In many respects, TransEar looks and is worn just like a BTE hearing aid, but instead of a traditional earmold, we use what we call a transfer unit—a full concha shell that contains a small mechanical oscillator. The oscillations are carried by the skull to the good cochlea. TransEar is not the first bone conduction hearing instrument, but it is the first to remedy single-sided deafness without occluding the good ear, without a bulky headband, and without surgery.
HPR: What types of hearing loss does TransEar work best for?
Schumaier TransEar is designed for single-sided deafness (SSD) or unaidable unilateral hearing loss. The “better” cochlea should have pure tone air conduction thresholds 30 dB HTL or better for the test frequencies of 500, 1,000, 2,000 Hz and 60 dB HTL or better at 3,000 Hz. For individuals with a “better” ear that exhibits a mixed or conductive hearing loss, bone conduction thresholds should be 30 dB HTL or better for the test frequencies of 500, 1,000, 2,000 Hz and 60 db HTL or better at 3,000 Hz. Complete indications for use are listed at www.transear.com.
HPR: When evaluating patients, what specific things should hearing health professionals look for when considering TransEar?
Schumaier There are many potential causes of single-sided deafness, some of which can be treated medically. So the first order of business would be to ensure that the patient’s condition has been medically evaluated by a licensed physician.
Then, if a hearing evaluation suggests a CROS aid, TransEar will be a better option in my opinion, because, like a CROS aid, TransEar utilizes the cochlea of the better ear, but unlike a CROS aid, it doesn’t occlude it. Individuals with good hearing in one ear are often frustrated by having their good ear blocked, and it’s the most frequent reason cited for the 90% rejection rate of CROS instruments. On the other hand, if the audiogram calls for a BICROS (because the better ear needs amplification), TransEar is usually not indicated, because of the need for 30 dB or better pure tone thresholds through 2,000 Hz in the good ear.
HPR: What are the contraindications?
Schumaier We would not want to fit TransEar on someone with chronic ear drainage. We require a normal ear canal and pinna on the “dead” side. Also, those with extremely small ear canals would not be considered good subjects.
HPR: What are the top questions/concerns that hearing health professionals have about TransEar?
Schumaier Because TransEar is relatively new (manufacturing began in late 2005), the most common questions are “How can I get one?” and “How does it work?” From a clinical perspective, we are frequently asked about patients who are marginal with respect to our fitting range. An example might be someone who has a 35 dB loss at 1,000 Hz in the good ear, but everything else fits the range. My experience so far is that those outside the fitting range are poor candidates, due to the narrow frequency range of bone conduction in general.
Another popular question relates to TransEar’s ability to help children, and we are learning something exciting here every day, it seems. With children, the success of the fit depends mainly on the size of the child’s ear. In my practice, I’ve seen very small kids with large ear canals, and the reverse is true as well, so there is no pat answer we can provide. The good news is that we have successfully fit a number of children, the youngest of which is 5, I believe. We have a great deal of interest in the pediatric market because of the data that show how kids with unilateral hearing loss develop socially and academically. One consideration for children is how to accommodate a child’s need for successive transfer units as his or her ear grows. As a company, Ear Technology has committed to meeting that need at nominal cost. We feel it’s that important.
We also receive quite a few inquiries about TransEar for ears with mixed and conductive losses. Our indications for use do not currently suggest such fittings, and my professional opinion is that high-powered air-conduction instruments will provide a better result due to their wider dynamic range. If data later suggest that TransEar might be a good solution, then we will petition the FDA for a change to our indications for use.
HPR: What makes TransEar unique?
Schumaier TransEar is both nonsurgical and nonocclusive, since it is worn only on the “dead” ear.
As you might imagine, good bone conduction depends on a close fit in the ear canal for proper function. Consequently, we are committed to building our shells using scanned images on rapid prototyping equipment, and we have made a substantial investment in that technology. It may be a bit unusual for a niche product such as TransEar, but we believe it is vital to assuring the comfortable fit necessary for a deep canal product such as TransEar. Incidentally, that’s why we require two impressions—in order to verify the accuracy of the impression and for our Shell Supervisor to determine whether perceived anomalies are in fact a true representation of the patient’s ear anatomy.
Like an air-conduction hearing aid, we offer a trial period. The transfer unit can be resized as the ear grows, and the fitting software is very easy to use.
HPR: What market trends fueled the development of TransEar?
Schumaier Everything I’ve invented is a direct result of my own experiences, both professional and personal. TransEar and Dry & Store (another of Ear Technology’s products) came about because of what I perceived as the market’s failure to meet a need my patients had. I’m a full-time dispensing audiologist, and I’ve been at it for over 30 years—so I have a really good feel for what is missing from the market. I do, and that is where Ear Technology Corp excels.
HPR: What services do you provide to hearing health professionals who offer TransEar?
Schumaier As with all of our products, our primary objective is to deliver a quality product. Next is support for the product, and the greatest thing we can do right off the bat is to give dispensing professionals rapid turnaround on their orders. As a small company, we have that ability. When problems occur—and they do with any hearing instrument—we can build a new transfer unit within hours if needed.
Again, relative to support services, we realize the importance of the relationship between the internal salesperson and the provider. Any staff turnover on our end means that we have to train a new person to our preferred way of doing business. We are fortunate at Ear Technology that over our almost 10-year history, turnover has been a non-issue. As a result, customers who regularly order Dry & Store units or Dry-Briks are often able to talk to the same person each time. Although we sell our Dry & Store line all over the world, our customers never seem to tire of a little Southern hospitality. We are confident that this will happen with TransEar as well.
HPR: Where is the market for single-sided deafness headed, and what part will Ear Technology play?
Schumaier Industry estimates are that 50,000 people in the United States are diagnosed with unilateral hearing loss every year, and some 200,000 worldwide. Most of these people are not being helped. As I mentioned earlier, acceptance by patients of CROS hearing aids is very low, and a number of hearing professionals, myself included, have not had good success with CROS aids. For those who rule out products that require surgery for single-sided deafness, TransEar is an easy-to-obtain alternative, and it can be fit by any licensed hearing health care professional.
I think that as an industry, we still have a lot to learn. Until BAHA and now TransEar, bone conduction was the stepsister we kept hidden in the closet. Ear Technology is committed to ongoing development and improvement on both the processor and the transfer unit/oscillator. I don’t believe that we have reached the limits of technology, so the best is yet to come.
HPR: How has Ear Technology Corporation evolved as a company since its inception?
Schumaier The company was originally formed in order to manufacture and distribute Dry & Store, which was admittedly a niche market in response to a specific need. We’re now in our ninth year, and Dry & Store is recognized around the world as the pinnacle of proper care for all types of hearing instruments. So, if our past is any indication of our future—and I think it is—then our business plan is pretty simple: identify a need, develop a remedy, and be the best.
It’s the same thing with TransEar—I saw a need for a new bone conduction hearing aid and resolved to do something about it. And due to our success and years of experience with Dry & Store, I wasn’t afraid to develop and bring TransEar to market. There is something different about TransEar, though, because it’s the first product that we’re actually manufacturing ourselves. We’ve made a sizeable investment in leading-edge equipment to maintain our high-quality standards, and our manufacturing employees are hired with those same standards in mind. We are fortunate to have a knowledgeable and stable staff, and it’s the quality of that staff that has enabled us to grow the business without adding a lot of overhead.
Our international business has grown significantly with Dry & Store. Our instructions are printed in 28 languages, and Dry & Store is routinely shipped all over the world. TransEar, on the other hand, is still available only in North America, but we’re getting an increasing number of inquiries from overseas, suggesting that there is a great need for the product worldwide. In time, I’m positive that TransEar will also grow into a widely distributed product overseas, but there are mountains of regulatory hurdles to be overcome before that happens, so we are patient. In the meantime, we do have patent protections in place internationally.
We’re a pretty focused company: we stick to what we know and what we do best. As far as trends go, we stay active in a number of professional organizations, so that a network of dispensing audiologists and research colleagues keeps us abreast of technology advances as well as our understanding of the hearing process. But it still comes down to my patients who are the primary source of inspiration. In daily practice, we face real-world challenges, and Ear Technology specializes in providing practical, real-world solutions. Our company motto says it well: “We’re helping people hear better, every day.”™