PCO School of Audiology Expands with New Clinic
Elkins Park, Pa—The PCO School of Audiology announced the establishment of its new audiology clinic on the first floor of the North Building at the Elkins Park Campus. Construction will be completed in late October, with the clinic opening in early November. The new clinic is the latest expansion for the school, which welcomed its first residential class this year.

“The development of the PCO Hearing, Balance, and Vision Clinic signals a coming together of doctors of audiology and optometry to provide a comprehensive cost effective, efficient model for the delivery of hearing, balance and vision services,” says Audiology School Dean George Osborne, PhD. “We trust this clinic will serve as a model to practitioners across the country and world.”

The Clinic will be run by George Lindley and Terri Ives, and will offer a full frequency-specific hearing evaluation of infants and young children, as well as one of Eastern Pennsylvania’s few rehabilitation balance centers.

Carsten Trads

Trads to Lead Walker Ameriphone
Chattanooga, Tenn — Walker Ameriphone, a division of Plantronics, Inc. (NYSE: PLT), has named international business and technology executive Carsten Trads as its new president. As president, Trads will direct the strategic and financial direction of Walker Ameriphone’s global initiatives, overseeing all aspects of the company’s daily operations, product development and sales and marketing. Trads formerly served as president of a leading hearing aid and diagnostic equipment manufacturer.

“Carsten is a seasoned global leader who brings highly specific knowledge about the hearing loss population to Walker Ameriphone,” says Ken Kannappan, CEO of Plantronics. “We anticipate that Carsten will be a catalyst for Walker Ameriphone’s future growth as we offer evolving technology that responds to the needs of this burgeoning community. Walker Ameriphone also commends the hard work and leadership of interim-president Michael Hartberger, who has successfully guided our company through a period of rapid expansion.”

“The market for communication equipment for hearing impaired individuals is rapidly expanding and much of the potential has remained untapped,” says Trads. “I think the strength of Walker Ameriphone’s patented Clarity Power technologies, combined with the resources of Plantronics, creates a substantial growth opportunity in this industry.”

Citizen’s Petitions Filed for Over-the-Counter Hearing Aids
Washington, DC —Citizen’s Petitions have been filed with the Food and Drug Administration (FDA) by audiologists Gail Gudmundsen, AuD, and Mead Killion, PhD, in an effort to change current regulations regarding the medical waiver requirement and to create a new “over the counter” (OTC) classification for hearing instruments. If the reforms were to be accepted by the FDA, a new class of hearing aids would be created that could be sold “off the shelf” in retail outlets and pharmacies.

Killion and Gudmundsen, who are married, have served in numerous capacities within the hearing health care field. Killion is founder and president of Etymotic Research, Elk Grove Village, Ill, and is the author or co-author of several inventions, including the K-AMP, CORFIG curves, and the use of horn tubing in BTEs. He holds 40 patents. Gudmundsen is a well-known private practice audiologist, author, and educator who has served on the boards of several audiology associations, and currently serves as the chair of the Illinois State Speech Pathology and Audiology Licensure Board, a governor-appointed position. Both have been involved in helping shape many of the leading audiological issues of the last two decades.

The issue of doing away with the current medical waiver system and creating a class of OTC hearing aids is not new to the hearing industry. The American Academy of Audiology (AAA) supports a current legislative resolution (HR 2821) sponsored by Reps. Jim Ryun (R-KS) and Lois Capps (D-CA) that would give Medicare beneficiaries the option of seeing an audiologist directly without referral from a medical doctor. Likewise, when Songbird Medical introduced its disposable hearing aid in 2000, the merits of OTC hearing aids and eliminating the waiver system were debated (Songbird did not actively advocate for either). Robert Oliveira, PhD, president of Hearing Components, a manufacturer of compliant ear tips that can be used in one-size-fits-most hearing aids, pointed out in a recent HR article (May 2001) that there are few treatment options for hearing loss compared to other serious progressive disorders. For example, he says cardiovascular treatments include dietary restrictions, diuretics, and beta-blockers for the milder conditions of hypertension and arrhythmia, then progress to angioplasty, heart bypass surgery, and transplantation for more extreme conditions. In contrast, the options presented by the hearing health care field are limited, especially for those in the early/mild loss category who generally go unserved.

In general, about one-half to two-thirds of the cost of a hearing aid consists of bundled professional fees, and a professionally fit custom hearing aid requires 2-6 trips to a dispensing office. Many contend that this system makes it difficult for “starter hearing aids” to achieve a low price point or enjoy widespread use by consumers. Opponents to changing the regulations contend that the medical waiver system is essential for catching serious hearing-related medical conditions (eg, acoustic neuroma, etc), and over-the-counter hearing aids would deprive patients of vital hearing services required for successful aural rehabilitation.

Medical Waiver Petition: The Citizen’s Petition submitted by Gudmundsen involves the proposed replacement of what is widely referred to as the “medical waiver system” for adults (Subpart H of the Labeling requirements in Section 801.420-801.421). Currently, federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. However, the law permits a fully informed adult to sign a waiver statement declining a medical evaluation for religious or personal beliefs. It is made clear that the exercise of such a waiver is not in the “best health interest” of the client. The waiver system essentially prohibits off-the-shelf hearing aids because it requires the distributor to obtain a signed waiver prior to the sale.

The Citizen’s Petition proposed by Gudmundsen, if adopted, would effectively end this waiver requirement for adults (regulations applying to children—namely, that they are required by law to be evaluated and treated by a medical professional and/or audiologist—would remain unchanged). The Citizen Petition’s proposed User Instructional Brochure would include text provided in person, by mail, or by a Web site that, among other things, says a hearing aid will not restore normal hearing, prevent progressive hearing loss, and that some hearing loss is caused by conditions that can be medically corrected. The text would also include the eight “red flag” medical conditions.

According to the petition, the operative principle that separates OTC drugs or devices from those that require prescription by a physician is whether misuse of that drug or device can cause harm to the user. The potential harm from direct purchase of a hearing aid without medical evaluation is negligible, says the petition. An appropriate analogy, it states, is the OTC use of reading glasses and aspirin: “Experience has taught us that the vast majority of people can make intelligent decisions with regard to reading glasses and aspirin. If they overlook a serious problem, they can subsequently consult medical personnel if poor vision or pain persists or worsens...[certain drugs, like antihistamines,] are now available over the counter, presumably because FDA concluded that the benefits of reduced cost and increased availability of these drugs outweighed any risks involved in allowing the consumer to decide when the use of these drugs was warranted.”

“We feel that [the current regulation] is an impediment to people getting into the system, and both petitions really speak to that point,” Gudmundsen told HR. “It’s not a denial of access that we’re currently confronted with; however, it is a barrier and a difficult one for the average consumer to overcome. And [Secretary of Health and Human Services] Tommy Thompson has vowed to eliminate barriers to healthcare, particularly for seniors.”

Romanian Hearing Project Gets Underway

Tricia Towle is spearheading a drive to supply hearing health care to Romania. Malvern, Pa — Dispensing audiologist Tricia Towle left for Cluj, Romania, in September to work with ENT physicians and to help the hearing-impaired for 2 years and possibly longer. Romania is an impoverished nation with one of the poorest health care systems of the former Eastern bloc nations. The people still live in poverty, earning only a median annual income of $1600. Through a Christian mission organization, International Team, Chicago, Towle has raised enough funds to provide for her monthly salary and needs for the two years (a little more than $1600 a year). She reports that donations of equipment have generously come in through many hearing aid and equipment manufacturers, as well as through hearing aid supply houses. It is hoped that donations to the Romanian Hearing Project of International Teams would help stock the three clinic sites with the necessary on-going supplies and to help offset the costs of hearing aids. Tax deductible monetary and/or equipment donations can be made through the Romanian Hearing Project at International Teams, 411 W. River Rd., Elgin, IL 60123 or phone 800 323 0428.

The petition also addresses the other avenues for gaining access to hearing aids. Gudmundsen told HR, “If you access the Internet search-engine Google and type in ‘hearing aids,’ a multitude of ads for mail-order hearing aids will appear. Some of them have a particular statement on them, some don’t. Similarly, you can go into any sporting goods store and buy what is the equivalent of a hearing aid marketed as a shooters plug or similar hearing protection device. I’m not criticizing these devices in any way, but my point is there are products on the market today that, for all intents and purposes, provide people with alternatives outside the professional hearing care distribution channel. Consumers are finding ways to get amplification with or without our help. In my view, it’s better to acknowledge this need or problem (however one sees it) and create regulations that will actually deal appropriately with consumers’ needs.”

OTC Hearing Aid Petition: The Citizen’s Petition put forward by Killion requests the establishment of a new OTC hearing aid classification that “grants over-the-counter sales, distribution and use status to one-size-fits-most hearing-aid-type devices that meet safety and efficacy requirements established by rule.” Killion’s argument for this change relies primarily on price, consumer choice, and the reasons that Gudmundsen points out above.

Killion makes it clear that he is not advocating the distribution of unrestricted hearing aid designs through the non-professional channel. “It is not that you should be able to manufacture and distribute any hearing aid without any kind of regulation or sell off-the-shelf 140 dB SPL hearing aids [that can damage someone’s residual hearing]. It should be obvious that there is a need for restrictions on what can be sold over the counter. However, if you are within the limits where a user can easily turn down the device, the [volume control and/or compression] system that protects them in that case is essentially the same system that protects them now.

“The essential question here,” continues Killion, “is ‘Who should decide what kind of hearing aid I can buy?’ In my view, we’re hoping to open the way for a low-cost hearing aid category. While it is true that there may be some poor products offered on the market, there will also certainly be good-quality off-the-shelf hearing aids that offer a genuine option for those consumers who are not motivated to go through the [time consuming] hearing rehabilitation process or spend a lot of money on hearing aids. The argument against the fact that there may be poor-quality hearing aids on the market under this system, in my view, is somewhat trivial. If I spend $100 for a piece of junk, it certainly wouldn’t be the first time in my life that I’ve found out that $100 can buy you a piece of junk, and I don’t need the FDA to protect me from my poor judgement.”

Although Killion admits that the K-AMP, a popular compression circuit owned by Etymotic Research, would have applications in the OTC market, he states that this is not the reason for filing the petition. “The involvement of the FDA in regulating hearing aids was the result of some unfortunate business practices that occurred many years ago [circa 1970s],” says Killion. “But a hearing aid is not the sort of device that is inherently harmful to people. You may waste your money, you may be disappointed, and there are costs to buying a bad hearing aid. But as long as it has some safeguards, it’s highly unlikely that the device will do you any harm. If you tell your friends about a poor experience with a particular OTC hearing aid, it should be a self-correcting situation; eventually, that company will go out of business. My point is that the FDA has been involved in regulating all the aspects of hearing aid manufacturing and distribution. And it has done this for so long that it is now a major issue to suggest that it get out of this part of hearing aid regulation.”

“The bottom line,” says Gudmundsen referring to both petitions, “is that people who are in need of amplification are simply not getting amplification—and this has been the situation for 20 years. By all indications, including the MarkeTrak surveys published in The Hearing Review, the situation is getting worse, not better. Only 20% of the people who need hearing help actually purchase a hearing aid. The cost issue is huge. There are some non-custom hearing aids offered for $300 and some for $50. We are now fortunate to have technology that provides a high-quality low-cost hearing aid. But, at present, consumers really have no way to access this kind of product.”

Even if the FDA were to adopt all or most of the petitions’ recommendations, it’s unclear what would happen nationwide. The distribution of hearing aids is regulated on both the federal and state levels. Most (but not all) states have laws requiring that consumers receive hearing aids only from qualified professionals who are licensed in that state. It is unclear how a change in the FDA regulations would effect regulations state-by-state. For example, should the FDA decide to change its regulations, some states might make similar changes while others might choose to retain some or all of their current regulations.

A copy of both petitions can be found at the HR Web site version of this news article at www.hearingreview.com.