IS IT ILLEGAL FOR AUDIOLOGISTS TO DISPENSE PSAPS?
Is it illegal for audiologists to dispense PSAPs? More broadly – are disruptive technologies also exploding healthcare professionals’ ability to prescribe or recommend to their patients?
I addressed these questions in my keynote, Listen to the Future at the Audacity conference for the Academy of Doctors of Audiology.
PSAPs disrupt the legal boundaries of audiologists’ practice
Audiologists dispensing Personal Sound Amplification Products (PSAPs) are not the only ones wondering whether new technologies are wreaking havoc with their existing understanding of scope of practice, FDA rules, and legal obligations.
In every healthcare profession, technological change is accelerating so fast that the average health and wellness practitioner can lose focus in the legal and regulatory maze.
The trail of breadcrumbs is 1.0 and the technology is exponential.
Let’s talk about PSAPs for a moment. We have, among other areas of healthcare law and regulation:
- FDA regulation of “hearing aids” and medical devices.
- State licensing laws of audiologists
- State laws governing dispensing of hearing aids
- State laws governing mail order and Internet (online) sales
- State laws regulating hearing aids, medical devices, and consumer products
- Professional standards of care
- Legal definitions of professional healthcare negligence
- Legal requirements of informed consent
- Consumer protection laws
- FDA regulation governing distributors of medical devices
- FTC advertising rules concerning marketing of health and wellness products
Audiologists, like other healthcare licensees, have to navigate this broad regulatory landscape.
So: Is it illegal for audiologists to dispense PSAPs?
Consumer protection laws cause confusion
States have a patchwork of consumer protection laws.
There are general prohibitions against false advertising that could be applied to audiology sales of hearing aids as well as PSAPs, and everything in between. There are specific prohibitions and rules related to mail and online advertising. There are definitions of “hearing aids” that include PSAPs and others that don’t.
Some statutes about mail and online advertising require those dispensing certain products via these methods to register with the State.
Some states (for example, Florida) prohibit distributing “hearing aids” through the mail to the ultimate consumer.
In some states, there have been lawsuits about whether the state statute is preempted by federal (FDA) law.
The takeaway here is to do the research and read the language of the statutes carefully, as well as any pronouncements by a regulatory board interpreting these statutes, and any cases that may arise out of the legal ambiguity.
Malpractice (Audiology Negligence) Issues
Simply recommending or dispensing a PSAP to a patient is not inherently malpractice.
Typically, negligence is defined as practicing below the standard of care, in a way that causes the patient injury.
If dispensing the PSAP is below the standard of care and this injures the patient, a plaintiff’s lawyer supposedly could argue that there was negligent. But this is not a foregone conclusion. In some cases, the PSAP might be more appropriate.
Particularly as defines get smarter with “cognitive” AI (artificial intelligence), regulatory distinctions between different kinds of products with different technologies, are likely to erode.
Informed Consent Issues
A second line of attack for the plaintiff’s malpractice lawyer is that the audiologist (or any licensed healthcare practitioner) failed to give adequate informed consent.
Informed consent typically means giving the patient a meaningful description of the risks and benefits of, and reasonable alternatives to, a medical or healthcare treatment.
A plaintiff’s lawyer could, hypothetically, argue that the practitioner provided inadequate informed consent, where the audiologist dispensed or recommended a PSAP in lieu of a hearing aid, and neglected to give the patient sufficient information to assess whether the PSAP was a reasonable and viable alternative; and because the choice was not sufficiently informed, the patient was worse off.
However, another way to see the legal puzzle is that if the PSAP is more clinically appropriate for a given patient, then failure to mention the PSAP as a therapeutic alternative, could be considered a failure of informed consent.
FDA medical device wrinkles
What about the fact that PSAPs are not FDA-cleared as medical devices?
At the moment, unlike hearing aids, PSAPs do not have to get FDA medical device clearance. There are many consumer electronics products that audiologists or other healthcare professionals may sell, that are not necessarily in the FDA legal category of “medical devices.”
FDA normally does not introduce on the practice of medicine or audiology (or another clinical healthcare profession). There are exceptions, but typically the policy is “hands-off.” Professional healthcare practices are regulated by the State (in particular through the state licensing function).
However, there is one important exception here: when an audiologist or other healthcare practitioner is selling a product through interstate commerce, that person becomes a distributor and could be subject to FDA rules. This applies where selling:
- hearing aids
- other medical devices
- dietary supplements
- drugs and biologics
On the federal, FTC advertising law could also apply.
Legal / illegal is too binary for a decision about how to practice. We typically advise clients more in terms of exposure and risk management–this is a more nuanced approach.
As well, it’s useful to issue-spot and break the problem down into the kinds of activities that could pose legal trouble.
- Are you engaged in professional practice, performing a service subject to your state’s licensing laws–or distributing a product in commerce?:
- Is your advertising compliant?
- Are there different layers of state law, that could apply in addition to federal FDA and FTC concerns?
- Do general consumer protection rules apply?
- Have you checked for specific, mail-order and Internet sales laws?
- Are you providing robust informed consent, and do your legal forms adequately document your informed consent practices?
This kind of step-by-step legal review can map out the roadblocks and way to overcome them so you can decrease exposure and develop smart practices. Breaking down the puzzle in this way will help you respond to a question like: “Is it illegal for audiologists to dispense PSAPs?”
Remember that compliance is not binary, and that legal solutions are best titrated to your situation.