|AAA Gears Up for Return to Salt Lake City
Reston, Va — Salt Lake City will play host to the American Academy of Audiology’s 16th Annual Convention & Expo from March 31-April 3. This year’s event promises to draw thousands of audiologists, exhibitors and students for four days of professional education and fun.
Attendees can expect to preview the latest technologies, gather information on ground-breaking discoveries, and learn about state-of-the-art procedures for diagnosing and treating hearing loss and balance disorders. With a full slate of 89 instructional courses, 28 featured sessions, and numerous research poster and podium sessions, pre-convention workshops and special events planned, attendees are assured of an exceptional educational experience.
“I think the excellent program we have planned, in combination with all the wonderful things that Salt Lake City has to offer, will give us our best convention yet,” says Gail Whitelaw, PhD, Convention 2004 Program Chair. “You couldn’t ask for a better setting than Salt Lake City.”
The exposition at the Salt Palace Convention Center is expected to draw 190 exhibitors and 80,000-sq-ft of exhibits. The convention kicks off on Wednesday, March 30th with pre-convention workshops, a consumer workshop, and an opening night reception. Thursday, April 1, offers featured sessions, the Academy’s General Assembly program, the opening of the exhibit hall, Academy Awards Reception, International Reception. Friday, April 2, offers attendees a breakfast while attending the Academy Business Meeting, featured sessions, exhibits, Student Research Forum, instructional courses, and poster sessions. Finally, Saturday, April 3, provides featured sessions, exhibits, round-tables, instructional courses, the annual Trivia Bowl, and Open Houses. For more information, visit www.audiology.org.
Hearing Aid Market Increases by 5% in 2003
Alexandria, Va – US hearing instrument sales during 2003 increased by 4.94% in 2003 compared to the 2002, according to statistics from the Hearing Industries Association (HIA). Most of the sales growth came in the second half of the year, as Quarters 3 and 4 of 2003 experienced a sales growth of 12.07% and 9.85% respectively. A net total of 1,997,139 were sold in the US last year—frustratingly close to the 2-million unit mark. However, about 53.4% of the sales growth in 2003 was due to increased government purchases (ie, Veterans Administration) which now account for about 1-in-7 (14.36%) of all the hearing aids purchased in the US. The VA increased its purchases by 21.2% in 2003 after essentially flat purchasing in 2002. Meanwhile, private practice/retail sales of hearing instruments (78.9%) rose by 2.6%—still a healthy number considering that these sales fell by 1.8% in 2002.
Sales of digital aids continued to dominate the market. Digital aids accounted for 73.1% of all hearing aids sold in the Fourth Quarter of 2003, and constituted 65.8% of all the hearing aids sold during 2003. For more information on last year’s hearing instrument market and what might be anticipated for 2004, see the article beginning on pg 18 in this issue of HR.
Citizens’ Petitions on Medical Waiver and OTC Hearing Aid Classification Rejected by FDA
Washington, DC — In February, two Citizen’s Petitions that had the potential to significantly change dispensing practices in the US were denied by the Food and Drug Administration (FDA). (For more detailed background on both of these petitions, see the October 2003 HR, pgs 12, 60-61).
The first petition, filed by Gail Gudmundsen, AuD, advocated for the abolishment of the current, required medical evaluation and waiver procedures prior to dispensing hearing instruments. Had it been adopted, the waiver requirement for adults would have been ended (regulations applying to children would have essentially been unchanged), and a new User Instructional Brochure would have included text explaining, among other things, that a hearing aid will not restore normal hearing or prevent progressive hearing loss. It would also have included the eight “red flag” medical conditions.
A letter by FDA Acting Deputy Director for Regulation and Policy Beverly Chernaik Rothstein to Dr. Gudmundsen says it rejected the petition largely due to safety reasons. “FDA is concerned that if prospective purchasers of hearing aids are not examined by a physician prior to purchasing and using the hearing aid, “red flag” ear conditions will go unrecognized and unevaluated,” wrote Rothstein. Rothstein also wrote that “Without appropriate screening for red flag conditions by a licensed physician, persons with hearing loss may purchase hearing aids to remedy their problems and may even experience some relief, while continuing to have serious medical conditions that should be properly diagnosed and treated.” The FDA also cited the JAMA article by Yueh et al. (April 16, 2003, for information see the May 2003 HR, p 12) which stated that up to 30% of older adult patients with presbycusis may have cerumen impaction and chronic otitis media that can be treated by the primary care physician.
The second petition, filed by Mead Killion, PhD, requested the establishment of a new “over-the-counter” 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 the rule.”
In a letter by Rothstein that was almost identical to the one sent to Dr. Gudmundsen, the FDA denied Dr. Killion’s petition on the basis of the same safety reasons. “In the preamble to the 1977 hearing aid final rule, the FDA adopted the recommended restrictions and concluded that safe and effective use of hearing aids required…medical evaluation by a licensed physician…before purchasing a hearing aid,” wrote Rothstein.
Interestingly, the FDA denied both requests by noting that “FDA continues to believe that the safe and effective use of hearing aids depends on the collateral measure of a medical examination to ensure that a hearing aid, rather than medical or surgical treatment, is the appropriate solution for a particular person’s hearing impairment.” The Agency then cited the ability to waive that exam as the rationale for denying the need for an OTC category, as people may already purchase hearing aids in that manner if they choose.
Prior to the FDA’s decision, the American Academy of Audiology (AAA) submitted comments to the agency opposing the two petitions. Although the Academy saw some merits within the arguments of the petitions, AAA President Brad Stach said that the organization opposed the petitions due to the same safety concerns that were cited by the FDA, as well as the possibility that parents might purchase OTC aids for their hearing-impaired children instead of taking the children to see an audiologist. Stach also questioned the petitions’ analogies to reading glasses (ie, he pointed out that hearing loss is a far more complex disability) and the assertion that the current cost and delivery system for hearing aids are responsible for the low (22.2%) use of hearing instruments by consumers. These issues were also a point of contention with the Hearing Industries Association (HIA) relative to Killion’s petition for OTC aids which it opposed.
American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Executive Vice President David R. Nielsen, MD, said that his organization opposed the two petitions “on the basis of patient safety and health,” and the Academy of Dispensing Audiologists (ADA) also filed last-minute commentaries opposing the petitions largely on the same grounds as those described above. Although the International Hearing Society (IHS) did not submit commentary, the organization’s leadership made it clear that they opposed the petitions and had made the FDA aware of the Society’s position. The Citizens’ Petitions and commentary are available at www.fda.gov.
Although opposition to the petitions was virtually unanimous from the professional organizations, and dispensing professionals probably opposed the petitions by about 7-to-1, many people in these organizations and leaders within the audiological community privately concede that both petitions made a number of good points. Many also say that—as Internet and mail-order sales of hearing aids continue to grow rapidly (ie, mail order hearing aid sales grew by 83% from 1997-2000, and Internet sales of hearing aids are burgeoning)—a frank discussion of hearing aid pricing, distribution, and service by the professional dispensing community, professional organizations, and government entities was beneficial to the hearing care field.
FDA Issues Draft Guidance to Improve Health Information
Washington, DC — The FDA issued three draft guidance documents in February designed to ensure reliable communications to consumers and health care practitioners about health conditions and medical-related products, including hearing aids. The three documents address how health-related information is provided to consumers through advertising and promotions, and is an attempt to ensure that the information presented is accurate and relies on solid science.
“The evidence shows that promotions directed to consumers can play an especially important role in helping patients start a discussion with their health care practitioner about conditions that are often unrecognized and therefore under-treated, such as diabetes, high blood pressure, high cholesterol, and depression,” says FDA Commissioner Mark B. McClellan, MD. “And we think those discussions should reflect a better understanding of the key risks and benefits of a product.” In a FDA study, of those patients who visited their doctors because of an ad they saw and who asked the doctor about that prescription drug by brand name, 87% actually had the condition the drug treats.
The first draft guidance document deals with alternatives to the lengthy, technically written summaries used by drug companies. Similarly, the second guidance document relates to advice for manufacturers that generate information designed to educate patients and health care practitioners about various medical conditions but do not promote a specific product. These types of communications are generally intended to get more people to discuss under-treated health problems with their doctors.
The third draft guidance document, entitled “Consumer-Directed Broadcast Advertising of Restricted Devices,” deals with restricted devices and specifically mentions hearing aids, certain types of contact lenses, and diagnostic tests as examples. This document provides advice for manufacturers on compliance with federal risk disclosure rules for consumer-directed broadcast advertising for medical devices with the goal of assuring that consumers are getting accurate information through device advertising. FDA says that it is providing clear, specific guidance to the applicable industries to help assure compliance with accurate ads that are not misleading. The agency says this guidance closely resembles similar guidance that FDA issued for prescription drugs in 1999.
Although these types of regulatory activities by the FDA generally make health care industries nervous, in truth, the issuance of these draft guidance documents many actually be viewed as good news to medical-related industries. It signals that FDA has realized that direct-to-consumer advertising is a good thing: This type of advertising clearly helps encourage consumers to address persistent and undertreated health problems. Also, the draft documents are a clear sign that FDA is serious about encouraging input from the industries that it regulates prior to issuing rules that have the potential to seriously effect consumer health care and related businesses.
|WCHH Pursues Global Hearing Health
Washington, DC — In February, the Deafness Research Foundation (DRF) announced a new global initiative called the World Council on Hearing Health (WCHH) designed to promote universal hearing health care. The initiative was unveiled at the National Hearing Conservation Association convention in Seattle.
“The WCHH has outlined a series of objectives, including global outreach programs, guidelines for research, and access to technology,” says DRF Executive Director Susan Greco. “Among them is the establishment of a Gold Standard for Hearing Health to be supported with a trio of specific projects in the future.”
The Hearing Healthy Vans Program is a example of these projects, as it is designed to send mobile hearing testing vans to major cities throughout the US and offer hearing screening for approximately 200 people each day. The goal is to screen thousands nationwide annually, and to distribute educational materials and hearing protection free to the public. The first Healthy Van was scheduled to roll out on Valentines Day of this year.
Targeting the general public, as well as individuals with hearing loss, the WCHH will host several Citizens Research and Hearing Health Conferences—day-long events that provide the latest information about hearing-related technology and research—in major cities throughout the US. The council will also be distributing an educational video and PSAs, entitled “Listen Smart,” to schools and youth programs. This video instructs people about the dangers of loud music and the need for hearing protection. It features several celebrities, including rock stars Ozzy Osbourne, Moby, Linkin Park, and Deborah Harry. The WCHH has also planned a multi-media outreach program, utilizing television, radio, newsprint, the Internet, and corporate-cause related sponsorship programs, according to the organization.
The initial slate of activities will culminate in 2006 when the WCHH holds its first-ever World Summit on Hearing Health. Citing statistics that project hearing loss for 700-million people in the world by 2015, global members of the WCHH will introduce at this summit a 10-year plan to curb hearing loss and decrease the incidence of hearing impairment around the world.
The WCHH is designed to expand on progress made under DRF’s National Campaign for Hearing Health. The organization is the public education and advocacy arm of DRF, committed to raising public awareness about hearing loss and the impact it has on individuals and society. Focusing on the platforms of prevention, detection, intervention, and research, the goal of WCHH is to support DRF’s ongoing mission to make a lifetime of hearing possible for all. The WCHH comprises corporate leaders from the US and abroad, as well as international trade organizations and medical institutions. For more information, visit the organization’s Web site at www.hearinghealth.net.
Walker-Ameriphone Changes Its Name to Clarity
Chattanooga, Tenn — Plantronics Inc has announced that it has changed the name of its Walker Ameriphone division, one of the nation’s leading manufacturers of amplified phones and related systems, to Clarity®. The new name is designed to underscore Clarity’s position as a provider of technology-based solutions for individuals with hearing impairment, according to company President Carsten Trads, a long-time global hearing industry executive who took the reigns as Clarity’s president in September.
“The company’s technology has been so successful and is now so well recognized in the hearing loss community, that we have decided to leverage our technology position and change our name to Clarity,” says Trads. He says the company’s flagship product, Clarity® Power™ is designed to deliver significantly more than the basic amplification offered by conventional amplified telephones. Incoming sound can be tailored in terms of amplification and high-frequencies, making it applicable for 95% of the hearing loss market. “Its strong name recognition and dependable quality make it the technology of choice for millions of people who have difficulty hearing,” says Trads. “Building on this existing, loyal customer base, we see a tremendous potential for long-term growth. We are poised to deliver the advanced hearing experience of Clarity Power for generations to come.”
Since 1999, Clarity has steadily increased its presence with major retail operations such as RadioShack, Kmart, Target and CVS pharmacies. The name change comes at a time when Clarity is also seeing increased interest in its products from the hearing loss community and hearing aid dispensing market, according to Trads. “For the past several years, we have seen a surge in consumer awareness of simple solutions for people with varying degrees of hearing loss,” says Trads. “As you know from my years of involvement in the hearing aid industry, I think hearing aids are a fantastic, life-changing solution for those who have hearing impairment. But at the same time, we all know that very often people need more help on the telephone than hearing aids alone can sometimes offer. The main obstacles to hearing aid use remain as stigma, price, performance in noise, and phone use…We have changed our name to send a clear message to those individuals and families— we can help.”
Trads says that the retail and dispensing market confused Walker and Ameriphone, often viewing them as if the companies were competitors with each other. He says that, under the Clarity brand name, the company can now solidify its position as the leading supplier of amplified telephones, notification systems, assistive listening devices, and other communication devices for the hearing loss and deaf markets. “Clarity has completed quite a journey in the past 5 years, and is in a great position for future growth, both domestically and internationally. Our long-term plans are to deliver the Clarity message to as many people as possible, while continuing to improve, enhance, and extend the products we offer.”
Among the latest products introduced by Clarity are a new version of its cordless amplified telephone (Clarity 435), reportedly the world’s first dual-speaker amplified telephone (CLS45i), and a Mobile Headset Amplifier (MHA100) introduced under the Plantronics brand, which is also said to be the first device of its kind.
The name change takes effect immediately, and includes a new Web site: www.clarityproducts.com
Hearing Components Forms Supply Alliance with Interton
Oakdale, Minn — Hearing Components has formed an alliance with hearing aid manufacturer Interton, Plymouth, Minn, in which Interton BTEs, including the company’s new IQ-Nano™ hearing aid, will now include Comply™ Snap Tip acoustic couplers.
The Comply Snap Tips, manufactured by Hearing Components, replace traditional earmolds, allowing dispensing professionals to fit BTEs to patients immediately and avoid the cost of custom earmolds. They are made from soft, high-tech, slow-recovery foam that forms an acoustic seal to fit the ear canal. Interton’s IQ-Nano BTEs feature IQ Signal Processing and state-of-the-art dual microphones. For more information, visit the company’s Web site at www.hearingcomponents.com.
Hearing Screening Makes Good Progress, But Still Needs Work
According to an article in Pediatrics for Parents (June 1, 2003), and reported on by www.hear-it.org, the US is making progress in its hearing screening of newborns, but 1.5 million infants each year are still leaving hospitals without having their hearing screened. Even in states with the most aggressive newborn hearing screening programs, such as Hawaii and Rhode Island, half of infants with hearing loss are not diagnosed until they are more than 3 months old. The good news is that 37 states now have laws on the books mandating hearing screening of newborns, and 70% of infants are being screened. About 30 out of every 10,000 newborns are affected by some type of hearing loss.
In the article, Karl R. White, director of the National Center for Hearing Assessment and Management at Utah State University, points out that even mild, unilateral hearing loss can have a substantial impact on a child’s development if not identified early in life. By the third grade, children with mild unilateral hearing loss not detected before age 6 months were 1.5 to 2 years behind their normal-hearing peers in math ability, according to a recent study. These same children were, by age 5, 1.5 to 2 years behind their peers in language development.
BHI Announces New Board Members
Alexandria, Va — The Better Hearing Institute (BHI) announced in January the election of 2004 officers and directors. BHI elected four directors to its 6-person Board. The directors elected for 3-year terms are: Cathy Jones, president of Phonak Inc; William Lankenau, president of Siemens Hearing Instruments, and Jerry Ruzicka, president of Starkey Labs Inc. Stephan Sagolla, general manager of Interton Inc was elected for a 2-year term on the Board.
Continuing to serve BHI in a leadership capacity are newly re-elected BHI President Michael Worning, president of Oticon Inc, and BHI Secretary/Treasurer Randy Raymond, vice president of Rayovac Corp. Stephan Sagolla was elected as BHI vice president.
“We are currently in the process of rebuilding and reinvigorating the Better Hearing Institute to fulfill its mission of educating the public and medical profession on hearing loss, its prevention and treatment.” says BHI Executive Director Sergei Kochkin. “We have the formidable task of publicly leveraging our knowledge on the impact of untreated hearing loss on quality of life, breaking down barriers which prevent the hearing-impaired from seeking help with their hearing loss, building BHI into a comprehensive resource for individuals with hearing loss as well as for hearing heath providers, and finally in educating more than 300,000 medical and healthcare professionals. Certainly the expertise and guidance of this Board will be critical to our success.”
At a December board meeting, BHI also recognized the 2003 outgoing directors for the time and expertise that they devoted to the organization during their service on the board. The outgoing directors are: Michael Jones, Phonak Inc, Dale Thorstad, Marcon, and Don Worthington, IHC Hearing & Balance Center, Salt Lake City.
For more information on BHI activities, see p 14 of this issue of HR.
NOAH Software Celebrates Its 10th Anniversary in May
Copenhagen, Denmark — The Hearing Instrument Manufacturers’ Software Association (HIMSA) celebrates its 10th anniversary of the NOAH standard in 2004. “In 1993, [many hearing aid manufacturers] had the foresight to see that cooperation is in everyone’s interest,” says HIMSA Managing Director Niels Munksgaard. “Everyone—from patients to hearing care professionals to manufacturers—have benefited from a single system for programming instruments and other client-related tasks.”
Since its introduction to the hearing industry in May 1994, NOAH has established its position as the primary software standard for the hearing care industry. Today, HIMSA reports that there are over 21,000 packages sold in over 85 countries. The quick adoption of NOAH had a significant effect on the acceptance of programmable hearing instruments worldwide. Almost 100 companies now support the NOAH standard, including over 40 hearing instrument manufacturers. HIMSA says it relies on these member companies to ensure that NOAH continues to meet the needs of hearing care professionals.
The NOAH System is not the only software based on the NOAH standard. Over 25 HIMSA member companies are dedicated to making NOAH-compatible office systems. Certified office systems have the same core features as NOAH System software, and can run NOAH 3 fitting and measurement modules. Additionally, office systems often include a range of additional useful features, such as scheduling and billing functionality.
In 2003, HIMSA released NOAHlink, a wireless and highly portable interface between NOAH and a hearing instrument. The system has already sold more than 2000 units, reports the company.
HIMSA is now currently involved in developing electronic ordering functionality for NOAH software. The first US manufacturers are expected to release their eTONA-compatible fitting modules in late 2004 (see Scott Peterson’s article in the March 2003 HR).
In the October 2003 HR Product Showcase (p. 48) an error was made by HR regarding the Siemens Hearing Instruments announcement of the new TRIANO hearing instrument. In this item, the first sentence was inadvertently distorted by HR to read: “Siemens has announced new research that reportedly proves individuals with hearing loss wearing TRIANO instruments with directional microphones can enjoy conversations in noisy places—in the process making them feel younger.” The text should have read: “New research reportedly proves individuals with hearing loss wearing TRIANO instruments with directional microphones can enjoy conversations in noisy places like they’re 25 again.” HR regrets the error.
In the February 2004 HR article by Mead Killion, PhD, entitled “Myths About Hearing in Noise and Directional Microphones”, an incorrect reference appeared (p. 73). The authors cited in reference #15 should have been: Taylor B and Powell S. The relationship between SNR loss and the audiogram. Poster presentation at: American Academy of Audiology convention; April 4, 2003; San Antonio, Tex.
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Arati Murti, associate editor