By Joanne Sproule
AHIP Executive Director
The passage of the U.S. Over-the-Counter Hearing Act of 2017 has the potential to have a very adverse effect on the quality of hearing health care for all persons with hearing loss. This represents a current, worrying trend in the hearing aid industry which will also negatively impact all health care professionals. It is therefore critical for all Canadian professional colleges and associations to understand this legislation, consider its potential impact, and to actively plan to either minimize or reduce the negative impact as much as possible.
On August 18, 2017 Donald Trump signed into law the U.S. Food and Drug Administration Reauthorization Act of 2017, legislation that provides for greater public access to over-the counter (OTC) hearing aids. This legislation means that adults with “perceived” mild-to-moderate hearing loss will be able to access OTC hearing aids without being seen by a certified and licensed Hearing Instrument Specialist or Audiologist.
This comes on the heels of the elimination of the “physician waiver” system which had required consumers first to seek a physician for a medical evaluation or to sign a waiver prior to obtaining a hearing aid.
This new legislation will require the U.S. FDA to create a category to regulate OTC hearing aids to meet safety, labelling, and consumer protection standards. It also mandates the US Food and Drug Administration (FDA) establish this new hearing aid category within three years of passage of the legislation, and finalize a rule within 180 days after the close of the comments period.
While some supporters of this legislation urge you not to consider OTCs in the same light as Personal Sound Amplification Products (PSAPs) it is impossible not to as we look at the history and details of this recently passed U.S. legislation.
Currently, the FDA and the Health Canada’s Food and Drugs Act do not allow PSAPs (also known as “Personal Sound Amplification Devices”) to be marketed as hearing aids or devices to improve impaired hearing.
The FDA’s mission is to protect the public health by assuring the safety, efficacy. and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that emit radiation.PSAPs as defined by the FDA are “wearable electronic products that are intended to amplify sounds for people who are not hearing impaired. PSAPs are not regulated under the Food, Drug and Cosmetic Act because they are not intended to treat, diagnose, or cure hearing impairment and do not alter the structure or function of the body.” As a result there is no regulatory classification, product code, or definition of these products.
Health Canada is the national regulatory authority for health product advertisements. Their commitment is to ensure that information in a health product advertisement is not false, misleading, or deceptive. All promotional health product messages, irrespective of the media in which they appear, must comply with the legislative and regulatory advertising provisions. Health Canada requires manufacturers of hearing aids to obtain a class II medical device licence prior to advertising in Canada as per section 27 of the Medical Devices Regulations.2 “Advertisement” is defined in Section 2 of the Food and Drugs Act is “any representation by any means what so ever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device.” Section 20(1) of the Food and Drugs Act prohibits advertising of medical devices in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, quality, character, value, composition, merit or safety. Health Canada has identified in the past that advertising of an unauthorized medical device would require investigation as it may be in contravention of this legislative provision.
While currently illegal in both the U.S. and Canada the PSAPs trend has intensified since the 2015 U.S. National Academy of Sciences and President’s Council of Advisors on Science and Technology (PCAST). issued its report to the then President Obama.
PCAST’s report focused on the following areas:
A) Age-related hearing loss is a substantial national problem.
B) The market for hearing aids is characterized by high cost and low innovation.
C) Current distribution channels create barriers to access.
D) Modest changes in FDA regulation could dramatically increase accessibility and innovation to tens of millions of Americans, without compromising patient safety.
E) PSAPs illustrate the negative consequences of the barriers to competition in the hearing market and its current regulatory regime.
A summary of the recommendations of the 2015 PCAST report is outlined below:
A) FDA designates a distinct category (“basic” hearing aids) and approves this class of hearing aids for OTC sale, both in stores and online, without the requirement for consultation with a credentialed professional.
B) FDA should not require language in PSAP labelling or advertising that excludes their use by individuals with age-related hearing loss no worse than mild-to-moderate.
C) As with the FDA “Eyeglass Rule” the Federal Trade Commission (FTC) should require audiologists and hearing instrument practitioners provide the customer a copy of their audiogram and the programmable audio file for a hearing aid at no additional cost and in a form that can be used by other dispensers and hearing aid vendors.
D) Similar to the “Contact Lens Rule” FTC should define a process by which patients may authorize hearing aid vendors to obtain a copy of their audiogram and recommendation and require the audiologist or hearing instrument practitioner to furnish such results at no additional costs.
Responses to these recommendations and support and opposition to the subsequent legislation were varied, a summary of some are as follows below:
International Hearing Society (IHS)
In the United States, the International Hearing Society (IHS) has been actively engaged in a variety of advocacy efforts opposing the PCAST recommendations and upcoming legislation. The IHS is a professional membership organization that represents hearing aid dispensing professionals, including dispensing audiologists and physicians, and the more than 9,000 hearing aid specialists who practice in the United States.
IHS formally responded to PCAST on December 2, 2015 opposing and providing comments on each recommendation. “While we respect the goal of PCAST, finding ways to expand the use of technology to improve hearing health access for Americans with hearing loss, IHS believes the PCAST’s narrow focus and the resultant recommendations could in fact create unnecessary divisions between all stakeholders who are committed to finding meaningful solutions that both maintain patient safety and promote access to care.”
On May 5, 2016 IHS outlined their concerns to the U.S. FDA stating that “IHS stands in strong opposition to the PCAST recommendations. These recommendations completely miss the mark on how to increase the use of amplification by people with hearing loss. The report instead offers a short-sighted and dangerous solution that disregards hearing loss as a medical and physiological condition and the FDA’s important role in overseeing medical devices, and instead treats hearing loss as a commodity for PSAP retailers. Jeopardizing the health of the hearing impaired to facilitate increased sales for the consumer electronic industry is not the answer.”
IHS urged the FDA to reject PCAST’s proposal and instead make final the 2013 Draft Guidance which would establish necessary policy to reduce consumer confusion and better ensure that consumers are purchasing the devices that are best suited to their personal and medical needs. On June 30, 2016 IHS provided detailed comments to the FDA citing existing regulations, history, the role of licensed hearing health care professionals, comparisons to other medical devices, medical research, court decisions, and testimonials.
IHS has also provided its members and supporters with opposition advocacy tools including: a customized, pre-written e-mail for members to send letters to their Members of Congress, assistance on how to conduct meetings with elected officials, congressional talking points and direction on how to engage their patients.
American Academy of Audiology (AAA)
On November 15, 2015, The American Academy of Audiology issued a response to the PCAST report supporting the PCAST recommendations encouraging greater competition and innovation within the hearing health care environment. It did, however, raise concerns about the report relating hearing aids to consumer electronics, noting that hearing aids are, by FDA regulation, a Class I medical device. A summary of the AAA comments/recommendations follows:
▪ That the FTC should require that all OTC devices be sold with an open platform format that will allow any audiologist to view, adjust, repair, or modify the parameters as needed by the patient.
▪ That any OTC device be labelled with the recommendation that it would be in the best interests of the patient to seek a comprehensive audiological evaluation prior to obtaining any device for the treatment of hearing loss. That labelling should also include a listing of possible red flag medical conditions and include warnings that these products should not be used by children.
▪ AAA noted concern about the use of online hearing tests and that it would be inappropriate to refer to any online or in-store test as a “hearing evaluation” or “diagnostic” procedure. They would support, however, online tests that provide screening procedures of sufficient degree to determine that a hearing loss falls inside or outside the mid-moderate hearing loss category.
▪ AAA supports the PCAST recommendation to work with Congress to initiate bipartisan legislation that would instruct FTC to issue a rule for hearing aids and PSAPs similar to the eyeglass and contact lens rules (which allows patients a copy of prescription at no cost). AAA state that these recommendations are consistent with current requirements of the Health Insurance Accountability and Portability Act of 1996 which ensures all patients have access to their medical records, including their audiogram and plan of care.
▪ Additional AAA recommendations include; reclassify hearing loss as a chronic health condition; requiring insurance coverage for hearing aid services. and elimination of the FDA medical evaluation requirement.
Hearing Aid Manufacturers – Hearing Industries Association (HIA)
The Hearing Industries Association (HIA) represents over 21 hearing aid manufacturers and related companies.
One of the most extensive responses to the October 2015 PCAST Report on Hearing Aids was from the HIA. A portion of this report states: “Specifically, HIA strongly opposes PCAST’s recommendation that OTC hearing aids be permitted in the United States, and its recommendation that these ‘basic’ hearing aids be exempt from the FDA regulations that protect American consumers using medical devices.”
“HIA also believes that PCAST’s recommendation allowing PSAPs to be promoted for hearing loss is contrary to the best interests of patients. Such deregulation would open the market for hearing products to a litany of claims made by any company that chose to market such products to people with hearing loss.” Labelling should also include a listing of red flag conditions and include warnings that these products should not be used by children.
The HIA report goes on to encourage the government take meaningful steps to have a positive and dramatic impact on the number of people who seek to treat their hearing loss, including coordinating and facilitating further studies on connections between untreated hearing loss and depression, dementia, and falls etc. They also recommend engaging organizations such as the Institute of Medicine to highlight the need for a far greater focus on hearing health by the medical community, especially general practitioners and geriatricians.
The HIA also felt that the government should launch a national public awareness campaign to encourage hearing checks and to inform the public that hearing loss is not a benign condition that can be ignored. They also stated that the U.S. Congress should enact a hearing aid tax credit.
The HIA concludes that the PCAST report’s recommendations regarding OTC hearing aid and the marketing of unregulated PSAPs to address hearing loss are profoundly flawed in multiple respects and that the PCAST recommendations would reduce the effective means of treating hearing loss and would endanger American with hearing loss.
The HIA report also included the example of Japan who has enacted similar legislation. Japan, a technologically advanced nation, deregulated hearing aids and now has a significantly lower rate of both hearing aid use and consumer satisfaction. HIA rightfully urged the United States not to follow that failed model.
In startling contrast to the IHS, the HIA and some audiology associations, most individual consumers, and consumer groups strongly and politically supported the PCAST recommendations and were overwhelmingly in favour of the legislation.
The Hearing Loss Association of America (HLAA) and the American Association of Retired Persons (ARRP) endorsed the Over-the-Counter Hearing aid Act legislation seeing OTC hearing aids as way to obtain lower costs and more access to hearing aids for those with hearing loss.
In fact, a call to action posted on the HLAA website provides sample e-mails and encourages members to contact their Senators and Representatives and urge them to support the Over-the-Counter Hearing Aid Act of 2017. One of the option paragraphs to send to their political representatives reads as follows:“As a hearing aid wearer, I can tell you first hand that the high cost of hearing aids is a hardship – mine cost thousands of dollars. Being able to buy hearing aids over the counter will reduce their cost, create more competition among hearing aid manufacturers, and will spur greater innovation by allowing more companies to enter the market.”
As part of my research, hundreds of more U.S. consumer comments and testimonials were found throughout the Internet, for the most part supporting the U.S. OTC legislation and endorsing the legislation. It is interesting that consumer comments very rarely include anything positive about hearing health care professionals.
For example, a small consumer organization tested three employees with a handful of inexpensive, OTC PSAPs to see how well they work. They found that if properly fitted and adjusted, they can help some people with mild-to-moderate hearing loss. Emphasizing no health professionals needed, I was beginning to wonder if “evidence-based” research even existed in the United States.
Another article on the AARP website entitled “Not Ready for a Hearing Aid But Need a Little Help” cites a testimonial about how the “Soundhawke” was an amazing value at around $350.00 and a good option rather than expensive hearing aids. Again, citing no hearing health professionals needed.
But wait, when researching the legislation prior to enactment, I thought there may be a light in the consumer tent! An article by Johnny Kampis on May 18, 2017, entitled “Elizabeth Warren’s Hearing Aid Cronyism” counters the proposed legislation with a new perspective it states: “With a committee vote pending on the Over-the-Counter Hearing Aid Act of 2017, critics of the legislation warn the bill would increase government regulations and raise the cost of personal sound amplification products (PSAP’S).” This article also provides a gun-owner group letter warning that language in the Act could even tread into Second Amendment rights. A quote from the “Gun Owners of America” letter is as follows:
“A survey of hunting-related merchandise offered by stores like Bass Pro Shops reveals a variety of hearing-aid-type devices marketed as hunting aids. These go by names like “hearing enhancer,” “game ear” and “hearing enhancement aid.” These devices operate similar to other hearing aids, and are intended to help hunters (included but not limited to hearing-impaired hunters) detect the presence of game. There is a pretty good chance that these hunting devices would fall within Warren’s definition of “over-the-counter hearing aid”. Which would mean that a new federal bureaucracy would be in charge of regulating hunting.”
Guess what? When the legislation was passed, an exception was included which reads: “(2) EXCEPTION – Such term does not include a personal sound amplification product intended to amplify sound for non hearing-impaired consumers in situations including hunting and bird watching.”
It continues to astonish me that one letter from a gun-owner’s group provided an exception in the legislation, and concerns from hearing health care professionals, researchers, the medical community and the industry were totally ignored (so far).
The current U.S. Over-the-Counter Hearing Aid Act of 2017 has not been formally responded to by any Canadian, Provincial or National Association or Regulatory College, by Canadian Consumers or by any recognized Canadian Consumer Organization.
However, I did locate one Canadian article in Canadian Audiologist, the official publication of the Canadian Academy of Audiology” entitled “US Food and Drug Administration Commitment to OTC Hearing Aid: Reflections for Canadian Practice.”
It states; “While the FDA has no jurisdiction in Canada, it would be naive to think that these changes will not have an effect on audiologists in our country. Depending on the province in which you reside, prices of hearing aids are relatively similar in many parts of Canada. As such, there is no doubt in my mind that lower costs OTC hearing aids will make their way into the Canadian market, driven by an equally robust Canadian consumer movement demanding the same.”
The article goes on to comment that we must find ways in which to better demonstrate to consumers the value of the role of the hearing health care professionals.
Please understand, in Canada, there is provincial and national legislation ensuring the protection of Canadian citizen regarding OTC hearing aids. Do not get caught up in the hype of US legislation, but at the same time be vigilant and ensure your provincial and national bodies understand the seriousness of the situation and respond appropriately.
You can support Canadian provincial and national legislation by collaborating with all consumer and health care professional provincial and national organizations to develop position papers and joint statements respecting hearing health care and OTC hearing aids showing national unity and being in the best interests of Canadians with hearing loss. This includes the importance of being evaluated by a qualified hearing health care professional and outlining the risks of OTC and mail-order hearing aids.
Hearing health care professionals must ensure the Canadian government, specifically Federal Minister of Health, the Honourable Ginette Petitpas Taylor, protects the Canadian public from a potential influx of unauthorized medical devices as a result of the upcoming U.S. Over-the-Counter Hearing Aid Act of 2017. It is incumbent upon Minister Petitpas Taylor to continue to closely monitor the U.S. OTC legislation and support the ongoing efforts of our American counterparts.
All provincial and national bodies representing those who have dedicated their lives to care for Canadians with hearing loss are leaders in our profession. As leaders, we hold a deep understanding of the issues surrounding OTCs and PASPs and must plan to minimize or reduce any negative impact from the recent US legislation. We must also recognize that this is a chance to initiate proactive efforts to strengthen and promote the hearing health care profession and to form and solidify provincial and national alliances. We can use this US legislation as an opportunity to educate our provincial and national government officials, the medical community, and the general public about responsible and caring hearing health care.
Works Cited or Consulted
Anderson B. Innovation and Strategic Thinking – The Art of the Possible. In: Association Management Development and Practices. Toronto: Canadian Society of Association Executives; 2013.
Gandel C. Not Ready for a Hearing Aid But Need a Little Help? May 27, 2015. Available at: http://www.aarp.org/health/conditions-treatments/info-2015/hearing-amplifiers-psaps.html
Congress.org. H.R.2430 - FDA Reauthorization Act of 2017. Available at: https://www.congress.gov/bill/115th-congress/house-bill/2430/text.
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Hearing Industries Association. Response of Hearing Industries Association to October 15 PCAST Report on Hearing Aids; page 2–3. http://www.hearing.org/uploadedFiles/Content/HIA_Updates_and_Bulletins/Response%20of%20HIA%20to%20October%202015%20PCAST%20Report%20on%20Hearing%20Aids%20%2800172863%29.pdf
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Mann EA. Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Amplification Products. Washington: US FDA; 2009. Available at http://www.fda.gov/MedicalDevices/DeviceRegulationsandGuidance/GuidanceDocuments/umc127086.htm
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Kampis J. Elizabeth Warren’s Hearing Aid Cronyism.” May 18, 2017. Available at: http://www.theamericanconservative.com/articles/elizabeth-warrens-hearing-aid-cronyism/.
President’s Council of Advisors on Science and Technology. Aging America and hearing loss: imperative of improved technologies. Washington: Author; 2015. Available at: https://obamawhitehouse.archives.gov/sites/default/files/microsites/ostp/PCAST/PCAST%20hearing%20letter%20report.pdf
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