August 31, 2012 Steven D. Silverman Director, Office of Compliance Center for Devices and Radiological Health U.S. Food and Drug Administration White Oak Office Building 66 10903 New Hampshire Avenue Silver Spring, MD 20993 Re: Illegal Marketing and Sale of Hearing Aids Dear Mr. Silverman: The Academy of Doctors of Audiology, American Speech-Language-Hearing Association, and International Hearing Society (collectively referred to as the “Hearing Health Organizations”) represent audiologists and hearing aid specialists. Collectively, we are seeking the FDA’s action to address concerns with hearing aids being sold as Personal Sound Amplifiers (PSAPs). The Hearing Health Organizations are very grateful for the work you have already done on behalf of persons with hearing loss to provide consumer education and industry guidance regarding the difference between hearing aids and personal sound amplifiers (PSAPs). And, while we feel there is a place for PSAPs in the marketplace, unfortunately, it appears there may be continued confusion, or perhaps blatant disregard, by some Vendors with regard to the guidance and regulations put forth by the FDA to protect consumers. We have observed many companies that we believe may be marketing hearing aids directly to consumers as personal sound amplifiers, either themselves or through outside Vendors (collectively referred to as “Vendors”). In at least one case, the hearing aids are marketed differently based on the Vendor, whereby in some cases as hearing aids and in others as personal sound amplifiers. Therefore, the Hearing Health Organizations urge the Food and Drug Administration (FDA) to investigate the following Vendors to determine whether they are violating the FDA regulations and, if appropriate, send warning letters instructing violating parties to cease and desist marketing and/or distributing these products for not complying with FDA regulations (please note that this may not be an exhaustive list of possible Vendors not in compliance): Neutronic Ear, sold at neutronicear.com1 RCA Symphonix Personal Sound Amplifier, sold by rcasymphonix.com; radioshack.com2; Amazon.com3; Gold Violin4; Harris Communications5; and BestBuy.com6 Lee Majors Bionic Hearing Aid, sold as Voice Clarifying Amplifier by Iconix Brand Group, Inc.; Hammacher Schlemmer7; Nova Tech Gadgets8; Gold Violin9; Bluestem Brands, Inc./Fingerhut10.; Overstock.com11; and SharperImage.com12 TV Ears Sports Amplifier, sold by TV Ears13 2200 RESEARCH BOULEVARD • ROCKVILLE, MARYLAND 20850-3289 • 301-296-5700 VOICE OR TTY • www.asha.org Steven D. Silverman August 31, 2012 Page 2 The Hearing Health Organizations make the following points to the FDA: • Vendors may be selling hearing aids advertised as being “designed for mild to moderate hearing loss” or that provide significant dB gain, appropriate for someone with mild to moderate hearing loss, but are advertising the devices as PSAPs. We urge the FDA to clarify and strengthen its regulations over companies that illegally market hearing aids as PSAPs. • Some vendors appear to be targeting consumers with possible hearing loss with a “directto-consumer” medical device in contravention of the FDA’s disclosure regulations and guidance, which were adopted to protect consumer safety. • Some vendors may be engaging in marketing activities that may put consumers at risk of purchasing unnecessary hearing aids, or devices that may be unsuitable for the consumers’ needs or provide excessive gain leading to hearing damage, and/or place consumers at risk of delaying or preventing the diagnosis and treatment of serious medical conditions. I. Regulatory Background A hearing aid is defined as “any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.”14 21 C.F.R. §801.420. This definition encompasses both air conduction and bone conduction devices in a variety of styles (e.g., behind-the-ear, in-the-canal, body worn). Hearing aids are regulated in the U.S. as medical devices. 21 C.F.R. §801.420. FDA regulations require that hearing aids not be distributed (or dispensed) without an examination by a medical doctor in the absence of a suitable waiver. 21 C.F.R. §801.421(a). The regulations are clear that a person with a hearing loss should have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. The purpose of a medical evaluation is to assure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased. The regulations further state that following the medical evaluation, the physician will give the consumer a written statement stating his or her hearing loss has been medically evaluated and that the consumer may be considered a candidate for a hearing aid. The physician will refer the consumer to an audiologist or a hearing aid dispenser, as appropriate, for a hearing aid evaluation. Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician, with exceptions only when a written waiver is signed that states the recipient of the hearing aid has religious or personal beliefs that preclude consultation with a physician. 21 C.F.R. §801.420 (c)(3). Another regulation, 21 C.F.R. §801.421, permits a waiver of the physician evaluation under certain circumstances with specified protections designed to ensure that the potential user of the hearing aid has been fully informed of the need for a medical examination. Additionally, children less than 18 years of age are not eligible for a waiver. The hearing aid dispenser must also retain records of all medical evaluation statements and waivers for a period of three years after dispensing the hearing aid. Steven D. Silverman August 31, 2012 Page 3 In addition to federal law, a number of states’ laws prohibit the mail-order distribution of hearing aids without a medical examination, including Arizona, California, Colorado, Florida, Georgia, Idaho, Kansas, Michigan, New York, Oregon, Rhode Island, South Carolina, and West Virginia. In 2009, the FDA issued guidelines distinguishing hearing aids from PSAPs. PSAPs are not subject to the FDA hearing aid device regulations. According to the FDA’s “Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,” PSAPs are intended to amplify environmental sound for non-hearing impaired consumers. PSAPs are not intended to compensate for hearing impairment and the FDA guidelines make clear that a device intended to address a partial or complete hearing loss (impaired hearing) is a hearing aid subject to FDA regulation. If a device is intended to amplify sounds for an individual who has not experienced a hearing loss–such as in listening to prey while hunting or hearing a lecturer from a distance–it does not fall under the regulatory purview of the FDA. According to FDA guidelines, while some of the technology and function of hearing aids and PSAPs may be similar, the intended use of each product determines whether it is a hearing aid or PSAP. The intended use may be established by labeling materials. Promotional materials that make claims or suggest the use of a PSAP for hearing impaired consumers, such as in the description of the types and severity of hearing loss, establish an intended use that causes the product to be a hearing aid device, and therefore subject to regulatory requirements for hearing aid devices. II. Vendors’ Products are Hearing Aids, Not PSAPs The following are observations of offerings by the aforementioned Vendors: • While the RCA Symphonix is marketed as a PSAP, materials on the website (www.rcasymphonix.com) state the device is “designed to help you hear better in all kinds of situations; large groups, crowded streets, office settings, watching TV, or at a restaurant with friends” and can provide an input gain of up to 30dB. According to industry standards, those needing 30dB of gain would be characterized as having “Moderate” hearing loss. • Neutronic Ear states on its website (www.neutronicear.com), “Neutronic Ear is a personal sound amplification product, not a hearing aid.” However, other areas of the site discuss hearing loss and the product’s ability to address hearing loss, “Are you having problems hearing or do you have trouble making out words? If you’re reading this, you’ve probably experienced some form of hearing ‘dysfunction.’ [We] have a simple, cost effective solution that helps 95% of the people experiencing the same hearing issues you are. Did you know that on average, someone experiencing some form of hearing loss will wait over eleven years to address the problem? 11 years! You’re probably one of the 95% of persons with a hearing issue we can help, and we’ll set you up in the privacy of your own home and let you try and hear the difference and experience the benefit first hand.”15 In addition, a recent article in PR Newswire about Neutronic Ear states that their Neutronic Ear PSAP is “[D]esigned as an alternative to costly and time-consuming hearing aids” and goes on to discuss age-related hearing loss and direct to the public distribution.16 Further, we ask the FDA to investigate whether Neutronic Ear is related to Crystal Care International, located at the same address, which had been found in violation of the FDA Steven D. Silverman August 31, 2012 Page 4 rules for inappropriately marketing and selling hearing aids as personal sound amplifiers in 2009. • Vendors sell a voice clarifying amplifier they label as the “Lee Majors Rechargeable Bionic Hearing Aid.” The device is an air conduction hearing device worn in the ear. The Vendors’ promotional materials display the device as a hearing aid, rather than a PSAP. On their websites, Vendors either describe the product and what it is used for and/or display a picture of the outer case, which has Lee Majors Rechargeable Bionic Hearing Aid written on it. The product displayed by each Vendor is the same, although the product’s description and promotional material may vary slightly. Some of the Vendors use language that the hearing aid is used to treat “mild to moderate hearing loss.” For example, on its website, Sharper Image states the following about the device, “Designed for mild to moderate hearing loss. Will help aid in hearing. Compatible with either right or left ear. Features micro-digital technology, which captures sound and amplifies it as it travel through your ear. Hearing what you’ve been missing!”17 Also, it would appear that the Lee Majors hearing aid originated with a Virginia-based company called Hearing Assist, LLC, who had filed for a trademark for the product back on February 16, 2009. It is not clear to us the nature of the marketing relationship between Hearing Assist and Vendors. Regardless of any business relationship, Vendors’ websites make no reference to FDA requirements, such as that found on Hearing Assist’s website. • TV Ears’ Sport Amplifier provides up to 40 dB gain and TV Ears suggests the product increases “the sounds you want to hear during recreational activities”. Examples include but are not limited to walking, dinner, and parties. In the opinion of Hearing Health Organizations, those persons with normal hearing abilities should not need amplification in order to participate in activities such as dinner, walking, and sports. According to the 2009 FDA guidelines, the intended use of the article determines whether it is a PSAP or hearing aid. In discerning intent, one should look at the promotional materials and whether the article is accurately described by the promotional materials. The FDA guidelines discuss that when promotional materials make claims or suggest the use of a PSAP for hearing impaired consumers, such as in the description of the types and severity of hearing loss, this establishes an intended use that the device is to be used as a hearing aid. In the present case, the Hearing Health Organizations question whether vendors may be targeting those with impaired mild to moderate hearing loss, regardless of how they otherwise describe the product. While marketing and distributing hearing aids, few, if any, Vendors appear to make an attempt to warn the consumer about FDA requirements for hearing aid sales before or at the time an order to purchase is made. Many of the Vendors do not appear to instruct potential customers to see a physician or hearing health professional or have a physical examination as required by FDA regulation, or provide a waiver form or instructions for consumers to appropriately waive the medical examination. It is not clear whether Vendors are collecting and maintaining for three years after purchase the medical examination or waiver forms as required by law. Given that they are not seeking such information from consumers, the Hearing Health Organizations question whether the Vendors are collecting the requisite data. When the Hearing Health Organizations attempted to purchase the Lee Majors Bionic Hearing Aid online from the relevant Vendors’ websites, they were not provided a medical waiver at any point prior to or at purchase. If these devices are found Steven D. Silverman August 31, 2012 Page 5 to be hearing aids, it appears these practices may be in clear violation of FDA standards for the dispensing of hearing aids. III. Vendors’ Illegal Marketing May Put Consumers at Risk Vendors’ possible illegal marketing activities put consumers at risk of purchasing unnecessary hearing aids or ones that may be unsuitable for the consumers’ needs, and/or place consumers at risk of delaying or preventing the diagnosis and treatment of serious medical conditions. The Hearing Health Organizations believe that the direct sale of hearing aids to the public without hearing health professionals’ support for assessment, fitting, and follow-up is not in the best interest of consumers. We also believe the sale of hearing aids marketed as PSAPs direct to consumers may have the unintended consequence of causing potential consumer harm–should a medical condition be ignored. Such a model could, at the least, lead to misdiagnosis of hearing loss, poorly fitted devices, and ultimately patient dissatisfaction. A worst case scenario could be the misdiagnosis of a significant undetected medical condition that remains untreated under the misguided impression that the “bionic wonder,” for example, is all a consumer needed to correct a hearing problem. Our significant experience and extensive research demonstrate that a devicedriven approach has not had the desired positive outcomes for individuals with hearing loss. There is substantial evidence to show that such an approach can result in significant consumer dissatisfaction with little or no hearing improvement. IV. Cease and Desist The FDA should issue a cease and desist warning to each Vendor who is found to be selling hearing aids without following the FDA guidelines to stop marketing its hearing aid online or in its retail stores, affiliates, and licensees, and through catalogues, telemarketing, and other means that are noncompliant with FDA regulations. Should any of the Vendors be found in violation, in light of the their illegal marketing actions, which evade the regulatory mechanism the FDA developed to protect consumers, we urge the FDA to issue a warning letter to each Vendor found in violation requiring them to cease and desist from marketing its hearing aids immediately. V. Need for Increased FDA Oversight We urge the FDA to clarify and strengthen its regulations over companies that illegally market hearing aids as PSAPs. These companies may claim the benefits of hearing aids in their promotional materials, but market the devices as PSAPs to avoid FDA compliance. Each day, more and more companies are using the Internet and telemarketing to sell hearing products they label or treat as PSAPs, but are in essence hearing aids. While the FDA issued guidelines in 2009, they are nonbinding and instructional in nature. We urge the FDA to make the guidelines mandatory, as well as provide additional examples of what constitutes PSAPs and to make it clear that such products should only be marketed to those who are not hearing impaired. The Hearing Health Organizations are highly concerned about product effectiveness and claims made to consumers by manufacturers, distributors, marketers, licensees, affiliates, and sellers that their devices can, for example, do incredible wonders like the bionic ear. Finally, the Hearing Health Organizations stand ready to work with you in developing regulations, guidelines, and standards that will protect the hearing health of millions of consumers. Steven D. Silverman August 31, 2012 Page 6 If you have questions regarding this letter, please contact the Hearing Health Organizations using the contact information provided below. Thank you for your consideration of this matter. Sincerely, Stephanie Czuhajewski, CAE Executive Director Academy of Doctors of Audiology 3493 Lansdowne Dr., Suite 2 Lexington, KY 40517 Phone: 866-493-5544 E-mail: [email protected] Arlene A. Pietranton, PhD, CAE Chief Executive Officer American Speech-Language-Hearing Association 2200 Research Boulevard Rockville, MD 20850-3289 Phone: 301-296-5701 E-mail: [email protected] Kathleen Mennillo, MBA Executive Director International Hearing Society 16880 Middlebelt Road, Suite 4 Livonia, MI 48154 Phone: 734-522-7200 E-mail: [email protected] cc: Ronald L. Swann Steven D. Silverman August 31, 2012 Page 7 1 Neutronic Ear, retrieved August 30, 2012, from neutronicear.com. 2 Radio Shack, retrieved August 30, 2012, from www.radioshack.com/product/index.jsp?productId=11595588. 3 RCA Symphonix, Amazon, retrieved August 30, 2012, from www.amazon.com/RCA-Symphonix-Personal-SoundAmplifier/dp/B0061LSU04. 4 RCA Symphonix, Gold Violin, retrieved August 30, 2012, from www.goldviolin.com/RCA-Symphonix-Personal-Sound-Amplifierp/93617.htm. 5 RCA Symphonix, Harris Communications, retrieved August 30, 2012, from www.harriscomm.com/index.php/symphonix.html. 6 RCA Symphonix, Best Buy, retrieved August 30, 2012, from www.bestbuy.com/site/RCA---Symphonix-Personal-SoundAmplifier/2317083.p?id=1218354912185&skuId=2317083. 7 Voice Clarifying Amplifier. Hammacher Schlemmer, retrieved August 30, 2012, from www.hammacher.com/product/79741. 8 Voice Clarifying Amplifier. NOVATECHGADGETS.COM, retrieved August 30, 2012, from http://novatechgadgets.com/amplifier.html. 9 Voice-Clarifying Personal Amplifier. Gold Violin, retrieved August 30, 2012, from www.goldviolin.com/Voice-ClarifyingPersonal-Amplifier-p/93197fl.htm. 10 Lee Majors Bionic Ear. Fingerhut, retrieved August 30, 2012, from www.fingerhut.com/product/lee-majors-bionicear/pk869.uts?ci_src=14110925&ci_sku=4PK8690000010&siteID=neQRQBqOKtQ-bLzIjxlLXUjOmBYKHzl4nw&ctid=69. 11 Lee Major’s Bionic Hearing Amplifier Extra Ear Piece. Overstock.com, retrieved August 30, 2012, from www.overstock.com/Health-Beauty/Lee-Majors-Bionic-Hearing-Amplifier-Extra-EarPiece/5685920/product.html?cid=209798&fp=F&TRACK=CSEShopzilla&mr:referralID=d2011207-ab35-11e1-9e8b001b2166c62d. 12 Voice Clarifying Amplifier. Sharper Image, retrieved August 30, 2012, from www.sharperimage.com/si/view/product/VoiceClarifying-Amplifier/200612?question=hearing%20loss. 13 TV Ears Sports Amplifier, TV Ears, retrieved August 30, 2012, from www.tvears.com/sports-amplifier-kit. 14 Under §201(h) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §321(h), a device is intended for use in the diagnosis of disease or other conditions in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body, except chemicals. 15 Neutronic Ear: Benefits and Uses, Neutronicear.com, retrieved August 30, 2012, from http://neutronicear.com/benefits-uses. 16 Neutronic Ear Launches Informative Knowledge Sharing Website. July 11, 2012. PR Newswire. Retrieved August 30, 2012, from www.prnewswire.com/news-releases/neutronic-ear-launches-informative-knowledge-sharing-website-162041675.html. 17 Voice Clarifying Amplifier. Sharper Image, retrieved August 30, 2012, from www.sharperimage.com/si/view/product/VoiceClarifying-Amplifier/200612?question=hearing%20loss.
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