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 proliability.com.







