This article discusses the pros, and cons of at least re-regulating the sale of hearing aids in Florida, and the potential impact such regulatory changes would have on consumers, and the marketplace.
Is it time to deregulate, or at least re-regulate the sale of hearing aids?
This very question, is completely heretical to an entire industry, that has gotten totally entrenched, within a regulated gatekeeper delivery system. The sale, and distribution of hearing aids is currently regulated at both the Federal, and State levels, with licensing requirement for dispensing at the state level, in forty eight out of fifty states.
This system of regulation has evolved along with an entire educational, audiological, manufacturing, and dispensing community, over the past fifty years, creating some very entrenched, and powerful, special interests.
Is it time to completely rethink the current gate keeper system, and move away from the medical model?
Several trends, facts and the natural evolution of the products and consumers buying them, are lending strong impetus to the deregulation movement. This article will explore these trends and the arguments for, and against further regulations.
First lets look at the products themselves. The equipment being used today to correct hearing loss is a far removed device, from those of years past.
Currently, most of the devices being fit are ‘digital’ in nature. This means that they are actually miniature audio computers, that are being programmed to certain output, and amplification characteristics that aren’t native to the device. These devices don’t produce any sound at all until they are programmed to do so.
Contrast that with the class A, B and D amplifiers of the past, which all came with a fixed set of acoustic output characteristics upon their manufacture. They were adjusted around the edges by using different microphones and receivers and by variable resistors, or capacitors placed in various parts of the circuitry to enable some degree of fine tuning.
Further evolution of our products, has taken this miniature, high speed audio computer, and piggybacked a digital radio transceiver right on top. This has allowed the hearing aids to talk first to each other, then to other devices, like Bluetooth dongles, remote controls, streamers of various sorts, and with Siemens latest development, open platform tablet computers.
These ear level devices, are becoming increasingly akin to a smart phone with each evolution of their chips. The hearing aid becomes a wireless ear bud, when it connects it’s wearer to their Bluetooth phone, iPad, IPod, tablet, or laptop.
Consumers are presently free to set their wireless ear buds to whatever volume suits their needs, and comfort levels, whether they have a hearing loss, or not, without the intervention of any licensed professional.
In February, of 2009 the FDA seemed to recognize this fact when they established an entire classification of products to be known as “personal sound amplification products”, that can be sold without any regulation, provided that they weren’t sold, as hearing aids, or to correct a hearing loss. Yet allowing for their sale for the enhancement of all manner of “difficult listening environments”.
So, if a device is sold to correct a hearing loss, it’s a hearing aid and highly regulated.
Under the FDA’s rules, the same device can be sold to enhance any number of difficult listening environments, and remain totally unregulated, provided that it is not sold to correct a hearing loss, which causes the same instrument to morph back into a highly regulated hearing aid.
So, the FDA says if, it’s sold to correct a hearing loss it falls under the classification of a medical device, as hearing loss is a serious medical condition, and so their regulations and all the various state regulations apply.
OK, if we accept this argument, as we must, given it has the weight of law, then everyone selling hearing aids needs to comply with both the FDA’s packaging, notification rules, and their red flags, as well as every state’s regulation associated with this device as well.
The problem is, that this distinction without a difference is not lost on either the public, or the Insurance and Senior marketing industry.
In October of 2011 United Health Care, the nation’s largest health insurer, with in excess of one hundred and nine billion dollars a year in premiums, announced that they had purchased their own hearing aid manufacturer, and were going to begin to offer these, over the Internet to their customers and the general public.
Coupled with their marketing arrangements with AARP, the nations largest organization of seniors, this signals a calculated, direct assault on the current, gatekeeper delivery system.
Unless we are to believe that these two giants made these decisions in some sort of legal vacuum, and without knowing about those forty-eight states that made such activities violations of their practice acts, then we must assume that they see the time, as being now, to upset the current delivery model.
Now, to the political climate, and trends at place and, at work in today’s body politic.
Less rather than more government, has become the accepted idea of the times. With ballooning budget deficits, and health care costs directly in the cross hairs of both sides of the political aisle, there is a general consensus that costs must be cut, if not benefits. With revenues flat, and more aging baby boomers swelling the roles of Medicare, and Medicaid, those costs that might be achieved by less, rather than more regulation become attractive topics for political discussion.
Clearly, AARP and United Health Care’s arrangements, when taken with the FDA’s establishment of a brand new class of products, specifically in the unregulated category, available to the public with no professional mandates, and compunctions attached, would argue that the decision to move personal, consumer amplification from the strictly medical, and professional realm, had already been made, at both the highest levels of the federal government and insurance industry.
Special vs. General Interests.
Unlike in times past, when once passed, a law was forever on the books, many states, including Florida have ‘sunset’ provisions that require a specific act of the legislature in order for them to continue in force, and in statutes. Florida’s Board of Hearing Aid Specialists and all the laws and rules dealing with the sale of hearing aids in Florida, are due to expire, if specific action is not taken in the 2012 legislature to continue them.
To see how concerned about this the Florida Society of Hearing Healthcare Professionals, formerly known as the Florida Hearing Aid Society, is about this, you need look no further than the front page plea on their publication, “the Otoscoop”, coming from their President.
All of the arguments presented in public for continuing the current regulatory framework are those of needing to protect the public from harm, and assure that certain established and evolving protocols, and standards are followed.
Having set these minimum practice standards for the legal sale of this regulated device, access is further restricted to only face to face encounters with a licensed dispensing professional.
The public is given no choice in the matter, as to the level of professional involvement they might deem appropriate. That has been predetermined in current statutes, by those who, through their education, position and regulation, have established that the general public is incapable of making these decisions for themselves, doing so, using the same rational used for the dispensing of drugs.
Now, there is no doubt, nor argument, that some segment of the population is in need of all of the procedures, and arts of both the audiological and medical communities regarding their hearing care. Some will even be incompetent, and totally incapable of making such decisions for themselves. The vast majority of the public falls somewhere in between the professionally educated and the totally ignorant and incompetent.
The current hearing aid dispensing regulations remove all choice in the matter from the public. By legislating to the lowest possible denominators within our society, to the level of those ignorant and incompetent, and therefor in need of the state’s intervention on their behalf to prevent real harm, they establish a gatekeeper status over the whole process and product line.
Let us look more closely at the harm that can come from the purchase of a hearing aid:
- The purchase of the hearing aid could mask a more serious health problem requiring direct medical intervention, such as a tumor, or infection in the middle, or outer ear. Or, even be purchased to correct a loss created by something, as common, as a canal plugged with wax and debris.
- The process of fitting the hearing aid by someone not properly trained, could in itself cause physical harm to a consumer, such as an improperly taken ear impression removing an entire ossicular chain, and causing not only great pain, but adding to whatever hearing loss that consumer may have had prior to the process.
- They could get a hearing aid that was totally unsuitable to their needs, and therefore waste a significant financial investment on something with limited, or no value to them.
But rather, finding that minimum level of regulatory involvement that will actually accomplish the goal of protecting the public, while both giving them the most choice in their health care decisions, and interfering the least in our free market.
As, I am only familiar with the rules and regulations regarding dispensing in Florida I will restrict my comments to those and the current FDA regulations.
Currently, under the statutes relating to the sale of hearing aids in Florida, the consumer has thirty days from the delivery of the instruments during which they can assess for themselves the effectiveness and value of their hearing aid purchase. If, they fail to achieve satisfaction for any reason, they are free to return it to the place of purchase for a full refund, less a 5% restocking fee and up to two hundred dollars in professional and fitting fees.
Failure to comply with such a consumer return, with a refund within another thirty days constitutes a felony of the third degree. As such, the seller in violation is subject to arrest without warrant, by any sworn law enforcement officer in the state, merely upon a showing of probable cause. Something that could be easily established by the customer’s receipts, correspondence etc. , or as easily and honestly refuted, by a wrongfully accused merchant by the production of their records of that consumer’s purchase, return and their repayment records.
This thirty day trial, evaluation provision, with the teeth of felony enforcement available from the closest sworn police officer, guarantees the consumer can achieve the value benefit mix from their purchase, that they are comfortable with. It does so without the need for any further Board, licensure, or state intervention what so ever, or without restricting their freedom to choose where, or from whom they purchase, nor does it require them to purchase any level of professional involvement at all.
As such it provides that valuable evaluation period that will let the consumer decide for themselves whether their purchases are of sufficient value to them to warrant the investment and serves a real, general, rather than special interest, and as such should be retained in any new regulations.
The thirty day trial, and return provision provides an elegant, simple to understand and enforceable means of protecting the public from the financial harm of a potentially inappropriate hearing aid purchase, and allows them to decide what is, and is not satisfactory both from an equipment, and a services standpoint.
Real consumer protection with teeth without limiting freedoms.
Now, as to licensure requirements that restrict points of access by requiring fees, minimum educational standards, mandatory certification, and re-certification, such as we have now, and the argument that such minimum standards are needed to protect the public form actual physical harm that can occur either by missing an existing medical condition, or in the fitting process itself.
The problem with this argument is that there is simply no evidence that restricting points of access through credentialing, and licensing of hearing aid dispensers, and audiologists actually affords any protection at all for the public, beyond that dealing with enforcement of the trial return, which does not require any Board, or State action at all.
Rather, under the current setup, the State and Board intercede, with a required notification on all hearing aid receipts that directs any complaints not resolved with the dispenser, or audiologist, to be forwarded to the respective Board in Tallahassee.
Such an arrangement has served not to quickly resolve any consumer complaints, or serve justice, but rather places both the complaining consumer, and the professional accused, into an open ended administrative law review process. One that is totally secret, up until ten days after a finding of probable cause, that the professional has violated some professional rule, or regulation, that would underlie any valid consumer complaint.
Or, conversely, if no violation is found, the whole matter remains totally secret, including who, what, and how much, was investigated for what, and charged for what, excepting, that the bill is sent on to the Board, for assessment to the licensing costs of every licensee.
As written, and currently implemented, the administrative law that governs the handling of such complaints places very strict time limits on how long after notification the accused professional has to respond to the state’s investigation into the matter, as well as that of answering any subsequent charges, that may be brought growing out of such an investigation.
However, while establishing these strict tolling requirements for all parties in this consumer complaint process, there is a later provision that waives the very time limits placed earlier, as regards the State’s handling of the matter.
What has happen is this; instead of the complaint process serving as a quick, and efficient means for the industry to weed out bad apples, through the professional licensure review process, we have failed miserably, as the Attorney General’s office who’s responsibility it is to investigate, review and prosecute such complaints, has routinely suspended the tolling requirements on the state, while interjecting endless legal process, and infinite review, under the secrecy afforded, prior to the probable cause process ever being achieved.
The blank check such secrecy has provided, has allowed this branch of government to use the process, as one to vet new hires, and generate departmental revenues, as every hour of investigation and review, is billed to the respective Board.
Continuing to operate under these rules of administrative law, has created millions plus in legal fees being charged to licensees across the state. Twice in the past, these excessive legal fees have resulted in not just over one hundred percent increases in the biannual license renewal fee, but also special assessments, more than doubling the cost of maintaining a license, while replacing speedy justice for anyone, with endless process, and costs for everyone.
When these actions can be initiated by other licensees, as they are required under specific reporting requirements built into the law, they place a tool into the hands of a competitor that may be wielded in such a way, as to cloud the accused professionals’ standing, and ability to purchase insurance, in a process that can take years to resolve, prior to anyone other than the accused knowing what is going on.
Open ended tolling, allows the state to shelve rather than resolve, any complaint, at any time
There is an old axiom of law that says it best, “Justice delayed, is justice denied.” Taking years to resolve complaints, billing millions for bogus investigations, and requiring the reporting of activities of competitors for open ended investigations, is the epitome of regulations of, for, and by the regulated.
This system serves no one, excepting those investigators, attorneys and Board members who wish to use the system for their own purposes. When neither the accused, nor accuser can move a process designed to protect both, to any kind of resolution, as we have now, then clearly their is no public benefit to continuing with such a broken system.
Contrast this with what would happen should a consumer actually come to harm by anyone fitting a hearing aid, who instead of contacting the State Board, contacted instead a local attorney, specializing in personal injury.
In this case, because of the strong financial incentive of a civil case, the attorney would quickly ascertain if, there was any actual consumer harm caused by the dispenser, and proceed accordingly.
Consumer complaints would be handled in a way that would guarantee that real harm was redressed quickly, and effectively, serve to police those performing harmful acts, and do so totally without any intervention, or involvement with any state apparatus, and cost nothing to administer.
Now, as to the potential for job creation and business growth.
Under the current hearing aid delivery rules, no one without either a license to dispense, a medical doctor, or an audiologist can sell, or dispense a hearing aid, legally in the state of Florida.
In order to expand a dispensing practice, the owner must either hire a doctor, an AUD level audiologist, or licensed hearing aid specialist.
Apprenticeship now comes with not just the passage of a Board exam, but a strictly supervised six month program that requires the purchase of home study materials, obtainable from only one source, the maintenance of a designation of “Board Certification” from an organization affiliated with the International Hearing Society, and precludes any licensee from training their help in any way excepting that prescribed by the State regulations, under penalty of revocation of the sponsoring specialists license, for any infraction of the rules that might occur during an apprenticeship.
These rules serve not to protect the public, but rather to restrict access to the profession, create an incestuous relationship with a professional organization, and it’s creations in the form of requiring only their material be used in this exclusive, home study course, required of every trainee, prior to certification for sitting for the State Board exam.
The incestuous nature of the relationship between the current Board of Hearing Aid Specialists and the Florida Society of Hearing Health Care Professionals is, further indicated by their repeated refusal to accept continuing education credit hours for hearing aid licensees, from any of the widely recognized online sources available to licensed professionals from Doctors to Audiologists, due to the deleterious effects such availability would have on attendance at the semi-annual conventions held by this society for provision of such CEU credits.
Very clearly at this point, Florida’s regulatory framework for dealing with the sale of hearing aids to the public, has evolved into one that fails to serve the public, while restricting points of access, job creation and free commerce within this state, and allows for potential mischief, and harassment, under the current system, to the financial detriment of all but, certain of those regulated.
The pending sunset of these laws, and rules offers the opportunity to allow them to go the way of unneeded and outdated laws, and just fade out of existence.
The public, and the profession will be better served by considerably less regulation, and no licensing, or board involvement at all.
Time for the sale of hearing aids in Florida to be guided by existing FDA regulations, backed up with a thirty day trial consumer trial period, as currently written, and let the rest pass into history.