Part V of this series on hearing aid distribution, or what might also be called service delivery paradigms, focuses on PSAPs. We have already seen from previous articles in this series that much has been suggested beyond the traditional audiology/hearing aid specialist/otolaryngology office sales from various hearing aid manufacturers. Major competition now comes from storefront hearing aid sales, networks, and Internet sales (direct-to-patient as well as Internet referral/consolidators). Additionally, telemedicine opportunities exist for remote audiometric testing and hearing aid fitting and management.1
Low Cost Hearing Aid/Personal Sound Device Market
Numerous comments have been made over the years stating that hearing aids are too expensive for many who need them. This presentation will not judge on this issue, but instead will provide information about what some have done to help provide lower-cost solutions. Certainly, many ventures have attempted to commercialize lower-cost hearing devices, but products often have not met acceptable listening expectations. But, this is changing as more advanced signal processing is incorporated into lower cost amplification devices.
PSAPs (Personal Sound Amplification Products) are electronic devices that allow an individual to listen better in noisy environments, or for use when the signal is not strong enough for a listener, regardless of the reason. PSAPs have actually been produced and sold for many years, although most early products were not known by this name. Prior to being called PSAPs, many were identified as “assistive listening devices” (ALDs), or just as sound amplifiers. Most were portable units that were carried in a pocket or which hung around the neck, but some were designed for in-the-ear-canal use. They were used for sound augmentation in certain situations: hearing in church or in meetings, or for watching TV, etc.
Many of the early sound amplification ALD devices were rather crude, unattractive, and inexpensive. As should be expected, these devices have consistently improved in sound quality, become smaller (to fit onto the ear or into the ear canal), and made cosmetically appealing. Such reinvention has resulted in unique design characteristics to make them look like ear buds used for listening to music or like Bluetooth™ earpieces. And, as the designs moved them into the ear canal, they started to look much like ITE, ITC, or even CIC hearing aids, which should be expected. How else would one design something to fit into the ear canal and not have it shaped like the ear canal?
When worn on the ear, some PSAPs take on the appearance of a behind-the-ear (BTE) hearing aid. Coincident with improved sound quality, micro-processing capabilities, volume controls for different environments, and sleek designs, some devices have started invading the traditional hearing aid device market, causing some confusion to consumers, and concern/dismay among hearing care professionals (audiologists and hearing aid dispensers who sell hearing aids for their livelihood). PSAPs are sold in stores and over the Internet, and cover a wide range of products and price points.
Adding to the confusion on the part of consumers is that not only are features starting to become blurred, but quality PSAPs tend to sell for prices ranging from as little as $15 (Songbird pop-up ads on the Internet) to several hundred dollars for a single unit having sophisticated noise-canceling and sound-enhancing technology often found in hearing aids. The prices are substantially less than for hearing aids where a typical pair costs closer to $4000 to $6000.
PSAPs and the FDA
PSAPs sales are differentiated from hearing aids ,according to FDA, Food, Drug, and Cosmetic Act Guidelines.2 While hearing aids and PSAPs both affect our ability to hear sound, the products have different intended uses, and are therefore subject to different regulatory controls. The FDA Guidance document identifies applicable legal requirements under the Food, Drug, and Cosmetic Act (the Act) for hearing aids and for personal sound amplification products (PSAPs).
“PSAPs are intended to amplify environmental sound for non-hearing-impaired consumers. They are not intended to compensate for hearing impairment. Examples of situations in which PSAPs typically are used include hunting (listening for prey), bird watching, listening to lectures with a distant speaker, and listening to soft sounds that would be difficult for normal hearing individuals to hear (e.g., distant conversations, performances). Because PSAPs are not intended to diagnose, treat, cure or mitigate disease and do not alter the structure or function of the body, they are not devices as defined in the Food, Drug and Cosmetic Act.”
PSAPs are classified as electronic, not medical devices. There is no regulatory classification, product code, or definition for them. Furthermore, there are no requirements for registration of manufacturers and listing of these products with FDA. As such, they are not regulated, are not required to be registered by the manufacturer, have no requirement to be listed with the FDA, do not require a prescription or medical clearance, and do not require a hearing test.
FDA action regarding PSAPs was influenced by activities initiated by audiologists Drs. Mead Killion and Gail Gudmundsen, starting in about 2001. They were invited by the FDA (Office of Device Evaluation, Center for Devices and Radiological Health) to discuss the need for change that would allow for low-cost amplification devices for persons with mild hearing loss. Specifically, the request was to seek FDA support for over-the-counter (direct-to-consumer) low-cost, quality amplification devices to assist persons otherwise unable to purchase hearing aids (e.g., fixed-income seniors, low-income citizens, and others), since about 80% of individuals who could benefit from amplification were not obtaining such help.
The FDA denied their Citizen’s Petitions in 2004, but they were then invited by the FDA and its working group to meet again in 2008 to address issues related to personal sound amplifiers. In 2009, the FDA addressed the Hearing Industries Association (HIA) and reported that it had drawn clear distinctions between hearing aids and personal sound amplification products (PSAPs), and posted a guidance document for consumers.
The FDA clarifies the intended use differences as follows:
“A hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing. A PSAP is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. While some of the technology and function of hearing aids and PSAPs may be similar, the intended use of each article determines whether it is a device or an electronic product. 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 device and therefore subject to the regulatory requirements for a hearing aid device, as described in this guidance.”
However, PSAPs are subject to defect reporting and adverse events, and must comply with the requirements to repurchase, repair, or replace electronic products required under 21 CFR Part 1004, as are many other products.
As someone who has worked with hearing aids for over 40 years, I’m not real certain what all this from the FDA means. It appears that the only difference between the two lies in how they are labeled, and that a PSAP is intended for “non-hearing-impaired persons.” Rogin states: “A PSAP ad is generally careful to say things like “hear someone in the next room” or “hear animals when you’re hunting.” But,”if the same device is manufactured by a registered hearing aid manufacturer and marketed for people with hearing loss, it becomes a hearing aid. It’s totally a matter of how the product is marketed, not the technology.”3
What makes this even more confusing is attempting to determine what a “non-hearing-impaired person” is as stated by the FDA? Is it based on audiometric thresholds (which would be a poor definition), and if so, what levels and what frequency? Or, is it based on the degree of “hurt?” Who decides?
PSAPs and the Traditional Hearing Aid Industry
There has been some pushback against PSAPs. A group of organizations representing sellers of hearing aids (audiologists and hearing aid specialists) sent a letter to the FDA alleging that four companies may be marketing hearing aids directly to consumers as PSAPs, either themselves or through outside vendors.4 The American Speech Language Hearing Association (ASHA), Academy of Doctors of Audiology (ADA), and the International Hearing Society (IHS) urged the Agency to address concerns that the companies identified were not operating in line with FDA compliance guidelines – either through confusion, or with blatant disregard. The expressed concern of the Organizations was that products from these companies were addressing hearing impairment, and this action required consumer protection. As would be expected, the PSAP companies disputed the charge.
The companies identified were (with the suggestion that there were most likely more):
- Neutronic Ear, sold at neutronicear.com
- RCA Symphonix Personal Sound Amplifier, sold by rcasymphonix.com, radioshack.com, Amazon.com, Gold Violin, Harris Communications, and BestBuy.com
- Lee Majors Bionic Hearing Aid, sold as Voice Clarifying Amplifier by Iconix Brand Group, Inc., Hammach Schlemmer, Nova Tech Gadgets, Gold Violin, Bluestem Brands, Inc., Fingerhut, Overstock.com, and SharperImage.com.
- TV Ears Sports Amplifier, sold by TV Ears.
Next week: PSAPs continued.
References and Footnotes
1 Krumm, M. Audiology telemedicine. Journal of Telemedicine and Telecare, 2007, 13 (5), 224-229.
2 Guidance for industry and FDA staff. Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products, Document issued on: February 25, 2009, U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, Ear, Nose, and Throat Devices Branch, Division of Ophthalmic, Neurological and Ear, Nose, and Throat Devices Office of Device Evaluation.
3Are Internet hearing aid sales the inevitable future? Hearing Journal, Vol. 64, (11)29,32,34, Nov. 2011.
4Illegal marketing and sale of hearing aids, letter submitted to the U.S. Food and Drug Administration from ADA, ASHA, and IHS, August 31, 2012.