Three PSAP Scenarios
Mike Metz
May 22, 2018

Things in the hearing field are changing.  No matter what your opinion on these potential changes, consideration of all the issues and potential impacts would seem judicious.  The following three scenarios might provide some direction for consideration.


Scenario 1

  A person with hearing loss goes on line and purchases two “mail order”, DIY, or PSAP hearing devices.  There is no professional input.

This person uses the hearing devices successfully for a couple of years.  As the hearing level(s) decrease (worsen), this person seeks medical help and a diagnosis.  It is determined that chronic ear problem(s) were made worse or allowed to worsen over this time and the devices likely contributed to this decrease in hearing.

Who, if anyone, has any degree of liability in this scenario?  Does the on-line company lessen or remove its responsibility by a printed statement in the advertisement or in the device box?  Does this consumer have any legal recourse with respect to this increased hearing loss? Can an attorney find fault with anyone Involved in this scenario?


Scenario 2 

A person with hearing loss goes into a retail store—drug store, electronics store, big-box store, whatever—and purchases a pair of OTC hearing devices.  There is no professional input.

This person uses the hearing devices successfully for a couple of years.  As the hearing level(s) decrease (worsen), this person seeks medical help and a diagnosis.  It is determined that chronic ear problem(s) were made worse or allowed to worsen over this time and the devices likely contributed to this decrease in hearing.

Does the retail store have any liability in this matter?  What could they do to minimize or eliminate any potential liability?  What if the store is owned by a chain of some type that employs other healthcare providers?  What if the store is a licensed hearing aid dispenser’s store?  Does any license of the dispenser in the store matter?  Is this essentially the same as Scenario 1 above or is it different?


Scenario 3 

A person with hearing loss goes into an audiologist’s office or clinic and purchases a pair of PSAPs.  This person shuns any tests that cost any money and refuses to take any professional advice from the audiologist.  The front desk manages the transaction.

This person uses the hearing devices successfully for a couple of years.  As the hearing level(s) decrease (worsen), this person seeks medical help and a diagnosis.  It is determined that chronic ear problem(s) were made worse or allowed to worsen over this time and the devices likely contributed to this decrease in hearing.

Does the audiologist or clinic have any liability in this scenario?  If the person refuses to be evaluated (even if signing a waiver), does that eliminate the seller’s liability?  Does the nature of the medical condition play a role in the liability (an acoustic nerve tumor versus a chronic middle ear infection)?  Is there more fertile ground for litigation as the responsibilities associated with a license increase?  That is, does this scenario cross into the malpractice arena?


General Questions & Discussion

Can anyone devise a way to minimize liability in cases like these?  Can the customer sign a waiver?  Is there any sort of free test that will isolate you from at least some professional responsibility?  Does your professional malpractice insurance protect you if the patient (customer) purchases from you and denies you the chance to practice your profession?

What if the patient or customer is under age?  If a pediatrician writes a release to fit devices to a child and the parent(s) decide on PSAPs, does that eliminate responsibility or liability?  How does this impact the child’s potential?

If you are an audiologist, put yourself in the patient’s position.  If you are a patient, put yourself in the audiologist’s position. 

These types of illustrations should at least give pause for thought.  The arrival of these hearing devices will present a different basket of problems.  And these problems may prove to be sufficiently different and disruptive that, if they are not addressed, may pose a bigger legal target than in the past.

If one were to seek a legal opinion on any of these three scenarios, it is likely that the opinion would be vague and dependent upon the exact details of any of the three situations.  Similarly, malpractice coverage would definitely depend on the specific details of the scenario[1].  Those clinicians or offices considering expanding business though PSAPs or DIY devices may wish to consult their own insurance carrier as well as an attorney for advice and direction.

If any audiologists have thought about these issues, can pose other related issues, or have answers to suggest, I invite you to post them on this site or email them to me in care of this site.  We will go through them and present them to others who read HHTM. 

In matters like this, collaboration and communication are not only legal, they should be encouraged.





[1] Mercer Health & Benefits Administrators, accessed at

birdsong hearing benefits
  1. One thing is obvious. If PSAP’s are sold at the same business standards of reading glasses, then the seller (store) has no liability whatsoever in the outcome of unintended consequences.These is no need to apply HIPAA regulations, or have the buyer sign any documentation for business safeguards. The procedures should be exactly like purchasing eyeglasses for reading.

    We need to start the process of de-linking HIPAA and other medical clauses from such sales, and no need either for liability insurances. We need to remove regulations that dampen the enthusiasm of both the buyer and seller. I think that will be great for the industry!!!!!

  2. I enjoy Dr. Metz’ posts because they tend to deal with real world issues, not just elitist theory. Now, related to his post:

    What if this person uses the OTC hearing devices successfully for not only a couple of years, but successfully for many years, and during this time the hearing level(s) decreases (worsens – a natural occurrence of the aging process which, by the way, is not a medical problem)? The scenario provided in the post assumes that as the hearing level(s) worsen that a person will seek medical help and a diagnosis after a couple of years, and assumes that a chronic ear-health-related problem is likely to be made worse (again, assuming that one existed or occurred). This is an assumption not currently borne out. Perhaps we could have some statistics on the number and type of ear-health-related chronic conditions that occur following millions of current and past traditional hearing aid usage, with most having been fitted with questionable, if not unrelated and/or insignificant, audiometric thresholds. I believe that the numbers are extremely few. More likely to occur is that the person does not seek a medical evaluation, gets a new, stronger OTC product as the hearing becomes worse, just as currently happens via the traditional hearing aid distribution system, where the concern about how the hearing aid has created a new chronic problem is low on the list.

    A hearing aid is not a true medical device, even by definition of the FDCA (Food, Drug, and Cosmetic Act), but actually a consumer product. The hearing aid industry fought very hard at the time it was such designated (about 1977) to keep it from being a medical device, realizing properly, that it is not a medical device. Traditional hearing aid dealers and hearing aid manufacturers at the time fought against it being a medical device, and the requirement of medical clearance, for fear of losing customers and by making it more difficult for individuals to seek hearing loss help. Audiologists, who were not heavily dispensing hearing aids at the time, argued for it to become a medical device in order to “force” traditional hearing aid dealers at the time to require their customers to have an audiological “hearing evaluation,” which was done best by requiring that consumers first see a medical doctor in facilities where many audiologists were employed. In their minds, everyone would be better served if hearing loss were managed as such. Ironically, as audiologists then became invested primarily in selling hearing aids, the idea that they should be first cleared by a medical doctor (and the possibly of a lost sale to an audiologist working for the physician), the medical clearance requirement became anathema to them and they became very fond of the medical waiver, and by heavy petitioning, helped to have it removed as a hearing aid fitting requirement in 2016. So, if the hearing aid is a “medical device,” why is there no “medicine” in the process?

    If the purpose of the OTC law is to meet its two primarily expressed goals of affordability and accessibility, the OTC should be managed like any traditional consumer product.

    1. I certainly enjoy it when Dr. Staab offers information on just about any topic. I recall all of these issues and directions. And, perhaps the differences in approach to this identity and/or “turf” issue has also spawned additional problems. The issue of liability with the sale of PSAPs will likely arise at some time due to the additional number of people using amplification devices, the general perceptions of equality between PSAPs and “professionally-fit” devices, the specific consumer confusion of “medical” versus “OTC” devices, the use of these devices In areas of NIHL compensation, fitness for duty, appropriateness for third party reimbursement, and probably many other associated considerations.

      The arguments for any and all amplification device inclusion in the medical arena certainly conflict with the arguments for non-inclusion. However, hearing loss, ear disease, aging, NIHL, and many of the recent associated problems which seem to be related, even distantly, to hearing ability are undeniably a part of the medical spectrum. This appears to be the case not only in the eyes of the government (to wit. the impending regulations), but also no doubt in the eyes of patients, physicians, and attorneys.

  3. I guess I am unclear how wearing a PSAP that cant amplify enough to damage someones hearing would be to blame for someones hearing gettibg worse versus having worn nothing.

    1. The issue is not any damage caused by the PSAP. It is the underlying damage of a condition that was undetected by the person or entity that sold the device(s). Liability may also arise from a number of issues related to licensing expectations–that is, what care one would have provided under other circumstances, what are the typical cautions for other customers/patients, and what efforts were made to assure device compatibility for the user. Further, with no testing or other individual clinical data, how can a trained professional argue that no harm was caused?

      1. I see this as similar to “peepers” that a person purchases OTC. What liability is involved with them? Why would it be different for an OTC hearing device, which I prefer to have the same non-limitations as does a PSAP? I also am not as convinced that current “professionals” are providing the safeguards as seem to be assumed. Are some trying to make the profession, as practiced by most, more than it really is? I realize that this would seem to be herecy coming from someone educated as an audiologist, but I believe this is an argument worth having if the goals of the OTC hearing aid law objectives are to be met – those of affordability and accessibility.

Leave a Reply