by Mike Metz, PhD
Consider the success of the “Big Box” sales of hearing aids. Costco alone has become the second largest dispensing entity of hearing instruments in the US, and just lowered the cost of their premium Kirkland 7.0 instruments. What do you suppose is their return-for-credit rate?
No matter which of the three possibilities—better, less, or the same as the rest of the industry—the cogent point is that there must be some people who wish to get clinical services on their hearing problems and cannot get those services from their local Big Box store. Relative to how often some clinical follow-up is needed, the logical guess is that the follow-up rate and the failure rate of Costco-dispensed aids is the same or worse than the rest of the industry.
“Locked” Hearing Aids and HIPAA
Perhaps some of these instrument users opt to obtain rehabilitative services from a clinician, say, perhaps, an audiologist. In an outside office, they will encounter the situation that no “outside” clinician can access the settings of their hearing aid software.
Inability to access parameters of certain hearing aids is not new. Some manufacturers or distributors have never allowed offices other than their own to obtain software for programming their instruments. Now it seems that big box retailers are playing the same “lock-out” game in an effort to keep their customers. (What other reason could there be?)
Such actions raise interesting questions: Do hearing aids that have “locked” programs violate the HIPAA regulations? If the instruments sold as locked have been labeled as hearing aids, doesn’t that make these devices a healthcare item? And as an item related to hearing healthcare, if the seller of the devices cannot deliver sufficient clinical services due to time, training or any other factor, what are the ethical and/or legal implications of such circumstance?
Already most of these sellers get away with hearing tests that are not really health tests as they are only for the purposes of making a sale. Many state laws require a test disclaimer. But, there are no disclaimers for the “hearing instrument” not being a real—unlocked— hearing aid.
A Healthcare Item or “Product”?
Are hearing instruments sold by such stores a “healthcare” product?
- If the answer were “yes”, it would seem that denying patient access to the software, which becomes part of the patient/customer’s healthcare file, is a violation of the HIPAA regulations. The manufacturers of most every hearing aid sold by these stores have signed on to the HIPAA regulations. Thus, the manufacturer in denying access to the software denies the patient is access to his or her health files.
- If people who sell these devices think they are not “healthcare” providers, the answer may still be “yes” due to the undeniable ties between hearing, hearing aids, manufacturer positions, and the long-standing history of hearing aids being in the health arena.
This question is obviously tied to the PSAP debate. If manufacturers supply PSAPs to big stores, does this take the PSAP out of the health arena? Can it depend on the manufacturer and what they call the device? Could it be that simple? Of course, that provides for it’s own downside in terms of a different sort of competition. The upside of this plan is that the consumer would not fall into the notion that Big Box care is the same as real health care.
If there is an audiologist in the Big Box mix—a healthcare-licensed professional—can this clinician be excused from the ethical and legal responsibilities involved in his or her professional license and label? Is it that easy to rid oneself of the responsibility placed by the public trust?
Who’s to blame, or better yet, what can a patient do? It would seem that the most reasonable answer, considering the nature and extent of hearing loss in our population, is to unlock the software and allow any hearing healthcare clinician access to the parameters of the instruments.
This restores the patient’s choice of clinicians and future hearing care as well as providing a cost choice. Of course, the Big Box stores would oppose this change as it disallows their exclusive hold on the products they sell. Any private label advantages would no longer be theirs (influence with their suppliers may prove this course difficult).
It’s still not a good idea to deny any clinician the programming data, the knowledge of, or the access to a hearing loss. Similarly, no information should be withheld from any health problem for that matter. Such denial is not in the best interest of the patient, the manufacturers, or the retailer.
Mike Metz, PhD, has been a practicing audiologist for over 45 years, having taught in several university settings and, in partnership with Bob Sandlin, providing continuing education for audiology and dispensing in California for over 3 decades. Mike owned and operated a private practice in Southern California for over 30 years. He has been professionally active in such areas as electric response testing, hearing conservation, hearing aid dispensing, and legal/ethical issues. He continues to practice in a limited manner in Irvine, California.
*title image courtesy History