Editor’s Note: Last week, HHTM published an interview with Paul Martin, audiologist and founder of Blue Ocean Advisors, LLC. In the article, Mr. Martin explained why he supports a proposed amendment to a bill in the Florida state legislature (SB 700), which would change the current laws surrounding the provision of hearing aids in the state.
Following publication of the interview, Kate Carr, President of the Hearing Industries Association (HIA) contacted HHTM and offered the following commentary to clarify HIA’s position on the Florida SB 700 bill as currently amended.
We appreciate the opportunity to respond to the representations made in the recent article “Pending Florida Legislation is a Hot Button Issue” posted on March 18, 2021.
As an industry, HIA firmly favors the trend toward broader consumer access and affordability of hearing aids. We view OTC and telehealth as changes that can potentially lead to improved consumer access when delivered in a safe manner. The Florida statute for testing requirements is archaic and out of date. However, we place particular emphasis on consumer safety and protection in our opposition to Florida SB 700 as amended. This emphasis is supported by the opposition to SB 700 submitted by the largest hearing loss consumer advocacy group in the country, the Hearing Loss Association of America (HLAA), as well as provider groups AAA and ASHA, and Amplifon. This issue has brought together providers, consumers, and, yes, industry, in support of telehealth but in a responsible and thoughtful manner, which is not the path SB 700 has taken.
Opposition to this amendment is not “driven by misinformation” as asserted by Mr. Martin. Let’s begin with the plain language of SB 700, as amended to include a waiver of not just a medical evaluation but of any and all testing (including tele-audiology) prior to obtaining a hearing aid. This differs and goes beyond FDA guidance issued in 2016 that stated FDA will not enforce the medical evaluation requirement for those 18 years of age and older. Prior to this guidance, FDA required “that all prospective hearing aid users must have a medical evaluation by a licensed physician to determine the cause of hearing loss and whether medical or surgical treatments would be more appropriate.”
Consider the statement of purpose in Florida’s statute relating to the fitting and dispensing of hearing aids, which “recognizes that the dispensing of hearing aids requires particularized knowledge and skill to ensure that the interests of the hearing-impaired public will be adequately served and safely protected. It recognizes that a poorly selected or fitted hearing aid not only will give little satisfaction but may interfere with hearing ability and, therefore, deems it necessary in the interest of the public health, safety, and welfare to regulate the dispensing of hearing aids in this state.” The statute goes on to also recognize the crucial balance between access and consumer protection by providing that “restrictions on the fitting and selling of hearing aids shall be imposed only to the extent necessary to protect the public from physical and economic harm, and restrictions shall not be imposed in a manner which will unreasonably affect the competitive market.”
We recognize this delicate balance and here lies the crux of the issue – this must be about consumer protection and appropriately identifying and treating hearing loss, which is best supported by the involvement of a licensed hearing care professional. Mr. Martin argues that the Florida proposed legislation will align the state with federal regulations allowing for a medical waiver. To clarify, the FDA guidance stating that the medical evaluation requirement will not be enforced refers to that provided by the licensed physician – not the licensed hearing care professional. It is important to note here that the federal regulations and state licensure provisions are different and have different purposes. The federal government regulates hearing aids as medical devices and states regulate through licensing laws. This regulatory structure is designed to provide the strongest consumer protection. Within this framework, states have been given discretion to adopt licensure laws that build on federal device regulations and are tailored to each state’s needs. While hearing loss is not specific to one age group, hearing loss disproportionately affects the older, more vulnerable adult population. (We’ll take a moment to note that Florida is home to the second largest over 65 population in the country.)
Turning next to the issue of Florida’s restriction on the distribution of hearing aids by mail and SB 700’s repeal of this restriction. Mr. Martin states the intent of this provision is to allow hearing care professionals to deliver hearing aids by mail (ostensibly while conducting certain services via telehealth). Again, the plain language does not support the intent. When you couple the complete waiver of any and all testing with lifting restrictions on distribution of hearing aids through the mail, you end up with direct-to-consumer, a gray area operating as a de facto OTC category but without safeguards or oversight. Under the FDA Reauthorization Act of 2017, which included the provision directing FDA to create a new category of OTC hearing aids, of importance was ensuring the safety and effectiveness of these new devices that would be accessible without intervention or involvement of a licensed hearing care professional. The important distinction here is these OTC devices will be limited to perceived (self identified) mild to moderate hearing loss. These products will come with labels, warnings, and indications of red flag conditions. This is not about “middling,” this is about ensuring access to safe and effective devices for appropriate populations. As HLAA articulated in their opposition to Florida’s proposed legislation, forthcoming FDA regulations will carefully define this new class of hearing aids and only for appropriate consumers. Further, and as ASHA notes in its letter of opposition, the FDA “still recommends that patients seeking a hearing aid obtain a medical evaluation or audiological evaluation.”
Instead of improving access for consumers, which we strongly support, Florida SB 700 as amended does very little to address telehealth and will cause significant confusion among Florida’s hearing loss population, including many seniors and elderly consumers. In treating hearing loss, the goal should always be to seek better health outcomes, not support a path for direct-to-consumer offers for hearing aids that offer limited or no benefit, or without appropriate guidance as to the proper safe and effective use of the medical device.
Mr. Martin also argues that after 25 years we cannot wait another day to make these substantial changes. The pandemic is cited as a justification, which is valid when discussing the permanency and codification of telehealth provisions. But that also does not mean one can avoid a patient-centered, careful review of scope and implications when crafting legislative language. In other states and even at the federal level, these serious telehealth discussions are ongoing. In fact, the U.S. House of Representatives’ Energy and Commerce Health Subcommittee recently held a nearly five-hour hearing on the future of telehealth. Considerations discussed as part of forward looking, patient-centered telehealth policies included standards of care and appropriate scope of telehealth services, access to broadband and telehealth technology, combating fraud, and patient privacy and satisfaction.
We must give full credit to hearing care professionals, including the current services offered by Lively, for their innovations and ingenuity in adapting their practices to the realities and limitations created by the ongoing pandemic. From curbside services, use of telehealth and virtual platforms, and enhanced office cleaning and use of personal protective equipment, audiologists and hearing aid specialists have risen above and beyond to provide hearing care services to their patients. They should and must be engaged when taking this next step toward responsible expansion and permanence of telehealth.
Mr. Martin closes with the statement that “those doing the change are convinced it is the right thing to do and the right time to do it, those that are asked to accept change are fearful of the unknown.” This amendment has nothing to do with improving access for those seeking to treat their hearing loss, but instead has the effect of doing away with licensing and the consumer protections that attach. When it comes to the health, safety, and wellbeing of Floridians who are part of the 38 million or more Americans with hearing loss, we are not willing to leap blindly into the unknown as this amendment does. Instead, we strive to work diligently with the hearing health care community to support clarity, understanding, and service to the consumer – an interest we all ultimately share.