Seven months have gone by since the publication of the President’s Council of Advisors on Science and Technology (PCAST) report on the ways that technology can help individuals with mild to moderate hearing loss.
The PCAST report seemed to be the start of a series of activities designed to change the delivery of hearing health products. The report started the drumbeat to remove FDA regulatory restrictions of any kind on PSAP’s to allow them to be marketed to both hearing impaired and non-hearing impaired consumers. PCAST also recommended that the FDA create a new category of OTC (over the counter) basic hearing aids. The underlying concept is that consumers are capable of self-testing, self-diagnosing and self-treating hearing loss. While PCAST limited its recommendations for opening the OTC market to those with self diagnosed mild to moderate hearing loss, others insisted that no matter what degree or severity of hearing loss existed, consumers should be allowed to choose self-diagnosing and treatment.
As audiologists, most of us were dismayed by the total absence of support or understanding of the professional services component. In fact, the PCAST report included negative and erroneous comments about the role of audiologists in the delivery of hearing health services. PCAST misstated the average cost of hearing aids, stated that most audiologists limited consumers to one brand of hearing aid, suggested that audiologists’ recommendations were based on “distributorship agreements” and referred to hearing aids as “beige plastic devices.”
Following the PCAST report, the National Academies of Sciences, Engineering and Medicine (NASEM) issued the report of its expert committee on the affordability and accessibility of hearing health care for adults. Mirroring the PCAST report, NASEM recommended that the FDA remove the regulation for a medical evaluation prior to hearing aid purchase. The NASEM report recommended three categories of devices: OTC “wearable hearing devices” designed for individuals with mild to moderate hearing loss, “hearing aids” for those with more severe hearing loss and PSAPs which would be intended for use by normal hearing individuals. The wearable hearing device category would be exempt from many quality system regulations (QSR) and would have the option to include tests for self-assessment of mild to moderate hearing loss. NASEM also recommended the unbundling of professional services in the pricing of hearing aids.
As a result of the PCAST and pending NASEM reports, the FDA reopened the comment period on its 2013 Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Draft Guidance for Industry and Food and Drug Administration Staff. The FDA asked for comments specific to key issues and recommendations identified in the PCAST reporting, including: “(1) The degree to which current FDA regulatory requirements may be acting as a barrier to hearing aid accessibility, affordability, and use of hearing aids; (2) the appropriateness of creating a “basic” category of hearing aids for consumers with “bilateral, gradual onset, mild-to-moderate age-related hearing loss” with appropriate labeling for over-the-counter sale; and (3) whether the benefits of expanded, over-the-counter access to hearing aids in this age-related hearing loss population outweigh the risks of forgoing the condition for sale (that the consumer may waive) that requires a medical evaluation to rule out treatable, potentially progressive causes of hearing loss.”
Comments to PCAST and the FDA generally fell into two camps – those believing that the FDA should continue to regulate hearing aids (AAA, ASHA, IHS, HIA, AAOO) and those who believed that accessibility and affordability were the most important factors (Consumer Technology Association (CTA), AARP and HLAA). Some recommended that the FDA go beyond the PCAST recommendations.
Writing on behalf of the Bose Corporation, Diane Van Tasell and William Rabinowitz recommended that the “FDA should designate as a distinct category non-surgical, air conduction hearing aids, which may include wireless capability, intended to be sold directly to consumers. FDA should adopt distinct rules for such devices.” The Bose letter also recommended that all air-conduction hearing aids should be included in this OTC category, and that there should be no restrictions to certain categories of hearing loss.
It is important for audiologists to look at what may seem to be a new voice at the table in all of these deliberations. The Consumer Technology Association (CTA) is a powerful and wealthy organization. Take a look at this description of activities at the 2014 International CES convention.
“The game changing quality of high-resolution audio will have benefits far beyond the audiophile community. Consumers with various degrees of hearing loss will also benefit, as better quality audio is incorporated into the products and services they use daily.
Many consumers—both with and without hearing loss—experience difficulty listening to another person nearby, understanding conversations in crowded rooms, understanding movie dialogue in a theater, listening to lectures in an otherwise quiet room, hearing the phone or doorbell ring, or with situations in which background noise might interfere with speech intelligibility. Any device, or combination of Innovate devices and software that helps someone hear better would benefit many consumers.
Consumers want access to affordable hearing assistance, and CE manufacturers want to provide such devices and can do so responsibly. Consumers should be trusted to make decisions about their hearing assistance, just as they do with vision assistance in the over-the-counter eyeglasses market. Amplifying speech so that it is audible, and thus more intelligible, is not a feature reserved solely for hearing aids. A host of devices called Personal Sound Amplification Products (PSAPs) in the jargon of the U.S. Food and Drug Administration (FDA), provide many of the benefits associated with hearing aids.
The PSAP industry is mirroring the extraordinary innovation in the CE industry. Many PSAP devices are functionally equivalent to hearing aids in terms of sound reproduction and their ability to be tuned precisely, even by untrained consumers. PSAPs are also innovating; some, for example, use the built-in functions of smartphones to amplify environmental sound. A high quality directional microphone combined with a smartphone, an app that allows the user to set their preferences, and a good pair of ear phones can greatly improve many difficult hearing situations, without the need for a hearing aid.
People with hearing loss should be able to take advantage of the range of products and services that could improve their personal hearing environment. Not all Americans with hearing loss must be treated with hearing aids. For these people, a larger market of more readily available solutions will be enough. The FDA should engage in further dialog with the PSAP industry and hearing-disabled consumers to ensure a vibrant marketplace of products and services that provide solutions for all levels of hearing and hearing loss.
Demographic studies show the increasing senior population will drive the market for assistive services. A vibrant marketplace for PSAPs will support long term health care goals.
To ensure wide adoption, standards bodies such as CEA (now CTA) must address key issues including barriers to accessibility and usability, interoperability and personalization. There will likely be a need for further industry-led, voluntary standards to address enhanced accessibility issues while also addressing public policy goals. CEA (Now CTA) welcomes input from all stakeholders on standards areas to be explored.”
It is not hard to see whose opinion was mirrored in the recommendations of PCAST and NASEM. More on the activities of CTA next time. In the meantime, I’d say buyer and audiologist beware.