The Contrarion: Locked Into What?

Gael Hannan
February 9, 2016
Michael Metz, PhD

Michael Metz, PhD

Michael Metz is back with The Contrarian, a monthly column that invites considered opinion and informed debate within the Audiology profession.  





Locked into What?


Consider this situation:  a physician prescribes specific medication for a patient’s illness. The medication is unlabeled and dispensed unmarked to the patient.  When the patient seeks another opinion about this medication and its use, a second physician cannot determine the nature or dosage.  Is this a violation of the HIPAA regulation?


What does the HIPPA regulation require?  When The Health Insurance Portability and Accountability Act of 1996 (HIPAA; Pub.L. 104–191, 110 Stat. 1936, enacted August 21, 1996) went into effect, it was determined at that time that audiologists were included under the act.  Since audiologists were deemed clinical providers, they are responsible for compliance to all aspects of this act.  Many attended classes or seminars to assure that they complied with the elements of this privacy and portability act.


Hearing aid manufacturers appeared somewhat confused concerning the requirements of their participation in the act.  Some companies did “check in” and participated in a limited fashion, most did not.  The reasoning behind these decisions could provide for interesting future discussions.


Hearing aid dispensers who are not audiologists are not required to adhere to the act since they are not licensed to provide medical services (they are exempt), despite their sale of a “regulated” device.  Could this have been an oversight or a “hole” in the regulation?  In thinking about this exclusion, what about an audiologist/dispenser who only sells hearing aids, say, in a big box store?  Can this audiologist disregard HIPPA since the employer is exempt?


There are several “big box” stores that sell hearing aids.  Many of the hearing aids sold in these locations use “locked” software that can only be accessed by that “big boxer” or someone who has the special software “key”.  So, when the patient seeks changes in the software program(s), they cannot obtain reprograming or modification services from anyone other than the exempt big box dispenser, whom we might assume often does not have the equipment, expertise, or maybe even the time to do what standard audiology protocols recommend.  Or they may seek someone else who has the “key”.


How do these entities—the store, the person selling the aids, and the manufacturer—relate to HIPPA?  If hearing aids are medical devices (covered under FDA regulations), and the audiologist (mandated under HIPAA) is fitting in a big box store (exempt), and the store retailing these medical devices is not “authorized” to provide recommended treatment (i.e. has no license to practice audiology), who prevails?  What recourse does the patient have if he/she seeks help beyond that which can be provided by the big boxer?  Should or does a manufacturer or the store have any responsibility for participation in the HIPPA requirements? Do these stores treat the devices as if they were PSAPs?  Can all this be legal?  Can big box stores and sellers of devices in these stores opt out as they wish?  Illegal and/or unethical, it certainly must be confusing to the customer.


The American Medical Association and the American Academy of Audiology, have weighed in on ethics of such situations and both have essentially concluded that, “if it walks/talks/acts like a duck, it’s a duck.”  Could a pharmacist at a big box store function outside of the HIPPA requirements? A dispenser may be exempt in such instances.  Is a licensed (or unlicensed) audiologist equally HIPPA exempt?


Perhaps the bigger question here involves professional aspects.  If an audiologist were not testing patients in the appropriate manner (protocol-based), and thus eliminating essential elements or standard procedures of care, would these actions be considered unethical, illegal, or both?  How about any legal action that arose from such selling situations?


Consider an audiologist who is offered a hearing aid job in a big box store.  What can he/she do to assure that they are functioning within the legal and ethical boundaries of their profession?  Does the store insist on sufficient time and equipment to adhere to professional protocols?  Do they offer the therapeutic care that audiologists are entitled and perhaps legally required to offer?  Would this improve care to the patient?


These stores may give a copy of any patient’s hearing test to that patient (HIPAA required), but do they still use hearing aids containing “locked” software?  We all have probably “inspected” the Big Box operations.  I didn’t see lots of equipment (it had to be all in the sound room because there was no room given outside the room other than for signs and advertising.)


One major purpose of these blogs is to raise issues that inspire discussion.  And, device sales by Big Box stores certainly have received plenty.  Does the HIPAA situation add a factor and thus need clarification?  Who is really “locked up” here?

  1. Mike,

    A very interesting and timely piece. One could actually argue that unlike major retailers, where they have hundreds of locations that people can visit to get service, independent practices that have privately labeled and ‘locked’ software could be creating an even worse problem here from a consumer perspective. While this certainly might be a business advantage, because people have to return for service, it very well could pose an ethical question as you state.

    Also, not all the major retailers use aids with locked software–this is up to the manufacturer in most cases. Having experience within the industry, I can tell you that often the decision to private label and ‘lock’ software for the major retailers/big box, believe it or not, is to appease the complaints of independents that want to be sure they aren’t offering the same product the retailers are offering for a fraction of the price. More or less, it’s a grand facade that all sides are guilty of playing.

    Thanks for your post. I hope it stirs some debate on these issues.

  2. Thank you for the comments.

    The inability of an audiologist’s patient to be in control of their clinical information is only part of this. Just like a drug store cannot deny a patient their information, neither may a big box audiologist deny the patient. No matter who asks for the “lock”, it would appear illegal/unethical for an audiologist to deny that or any other “clinical” information such as an audiogram to any patient.

    Much of the thinking in this post (not the typos and other mistakes) stems from information obtained from an attorney/physician who is well versed in these matters. In discussing this issue, particularly in light of the coming PSAP controversy, we/I wanted to make sure that all the problems were being considered by all involved. Essentially, as with pharmacists, audiologists who work in a big box environment cannot abandon their legal and ethical responsibilities as licensed clinicians. It does not matter who makes the decisions, if the audiologist chooses to work in that environment, the legal and/or ethical responsibilities reside with the audiologist.

  3. It is so frustrating to me when I see someone with hearing aids that I can not program due to locked software. The majority of these come from well known, large retail practices. These patients end up in front of me due to unsatisfactory care. This is one of many issues in the industry that should be addressed.

    Great post!!

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