by Granville Y Brady Jr, AuD

This post explores the use of PSAPs and OTC hearing aids used to treat hearing difficulty and the possible liability incurred when these devices fail to meet a patient’s expectations or cause the patient to be harmed. Some consumers who purchase PSAP’s and OTC’s will likely consult an audiologist to assist them with the fitting and adjustment of the devices.  Audiologists must decide whether fitting these devices poses a professional risk for them.

 

Changes at the FDA

 

If proposed legislation passes, purchasers of OTC hearing aids and PSAPs require no testing of hearing loss, no fitting by a professional and no follow up. They are “one size fits” all devices that are self-fitted and stick into the ear canal much like a Bluetooth device for cell phones. OTC hearing aids would be available without any audiological examination or professional fitting.

 

PSAPs and Hearing Improvement

 

PSAPs are not governed by any federal agency and hearing aids are currently listed as Class 1 Medical devices controlled by the FDA.  State hearing aid licensing laws would be pre-empted by exemption as well. Since PSAPs are marketed as devices that amplify sounds for normal listeners, any injury that would occur by the misuse of the PSAP could exempt all parties from liability if used to amplify sounds for a hearing impaired normal listener.  However the misuse of PSAPs to improve hearing or as hearing aids might place them in a different category when used as part of an audiologist’s treatment protocol as explained in the next paragraph.

Hearing loss can be classified as a disease with hearing aids as being medically necessary.  However the misuse of a product not specifically designed to treat hearing loss could be subject to a legal challenge especially when the device is dispensed or sold by a licensed professional. The proliferation of these devices, unregulated, untested and sold without regard to the consumer’s hearing loss, ability to operate them and possible damage from high levels of amplified sound are bound to cause problems that attorneys specializing in negligence and product liability would consider.

 

Product Liability Primer

 

A plaintiff in a product liability case must prove that the product that caused injury was defective, and that the defect made the product unreasonably dangerous. There are three types of defects that might cause injury and give rise to manufacturer or supplier liability:

  • design defects that are present at the beginning of manufacturing that results in unsafe use;
  • manufacturing defects resulting from poor quality control while the product is made;
  • marketing defects e.g. no package safety warnings.

Some consumers who purchase PSAP’s and OTCs will likely consult an audiologist to assist them with the fitting and adjustment of the devices.  Audiologists must decide whether fitting these devices poses a professional risk for them.

 

Audiologists’ Exposures to Liability Risk

 

  • Device Output and Gain

One the most obvious manufacturing defects is the output setting on the device.  Are the devices set at maximum output? If so, any resulting noise induced hearing loss could exacerbate the consumer’s threshold shift, create tinnitus and be very uncomfortable in some listening situations. In patients with hearing loss attributable to ototoxicity the loss is often exacerbated when a damaged cochlea is exposed to even moderate levels of noise. Thus a patient with an ototoxic loss that uses an unregulated PSAP could experience a greater threshold loss. The audiologist who assists a patient with a PSAP could be liable even if the device is measured in a Real Ear test box since there are no current specifications for the gain and output of these devices. Where the PSAPs are mass produced without serial numbers, there is likely to be little or no quality control over the device’s gain, output or frequency response. 

 

  •  Reactions and Infections

Moreover, the materials used are designed to be inserted into a human ear canal.  Allergic reactions to some latex products, fungal infections from aseptic handling during manufacturing and poorly fitted products that cause an abrasion in the ear canal are just three of the potential dangers of these products. Unlike manufacturers of hearing aids where strict hygiene standards are maintained and a chain of custody from the supplier to the audiologist is well documented1, no such hygiene standards or chain of custody is required.   

 

  •  Pathologies and Disorders of the Auditory System

Another issue that leads to a potential liability suit is testing for a hearing loss.  PSAP companies may claim that no test is necessary because their devices are not hearing aids. Presumably, under the proposed legislation, the consumer purchasing an OTC hearing aid would not be required to have a professional evaluation. Therefore a consumer with a cholesteatoma, impacted cerumen, acoustic neuroma and other disorders of the ear can buy a PSAP.

The audiologist must be careful when assisting a PSAP/OTC consumer to determine that no underlying pathology exists which would contraindicate use of amplification.  It is the audiologist that must be diligent to document that best practices are maintained for all cases. An exception would be for a patient that is tested and not fitted.  Results of an audiometric examination must be given to a patient when requested.  If the patient decides to purchase a PSAP or OTC hearing aid and is subsequently harmed by the device, the patient cannot blame the audiologist because there was no direct involvement. However if the audiologist fabricates an earmold for use with any of these devices and the consumer claims he was harmed, then some degree of liability might be assessed to the audiologist.

 

No Protocols for PSAPs or OTCs

 

At the present time there are no protocols for dealing with PSAPs or OTC hearing aids.  When the device fails to meet expectations, if has been argued that audiologists should step in offer assistance.  A clearly written protocol for these cases is essential to avoid liability. A suggested protocol might include:

  1. visual inspection of the external auditory canals
  2. comprehensive history
  3. audiological examination
  4. frequency, gain and output analyses of the device(s)
  5. Speech mapping2
  6. a photograph of the devices in or on the ears
  7. thorough explanation of how they operate
  8. a signed patient’s statement attesting to all of the above

Although the audiologist cannot be absolved from negligence, the written statement would cover all of the bases should the patient later file a complaint. In cases where the PSAP or OTC hearing aid is either ineffective3 or poses a danger to the patient, it is the audiologist’s responsibility to inform the patient in writing of the potential dangers in using the device.

 

Negligence versus Product Liability

 

In most instances, it is the plaintiff’s responsibility to prove product liability resulting in damage.  However, when the patient is harmed by the provider invokes the doctrine known as “res ipsa loquitur”. The burden of product liability is shifted to the defendant. Translated, this Latin term means “the thing speaks for itself,” and indicates that the defect at issue would not exist unless someone was negligent. If the doctrine is successfully invoked, the plaintiff is no longer required to prove how the defendant was negligent; rather, the defendant is required to prove that it was not negligent.  For example, inserting the dome from a PSAP into an ear canal where exostosis was present and undetected by the audiologist could result in injury that was not attributable to the PSAP but to the negligence of the audiologist in forcing the dome into the ear canal.

Of the two concepts, it is much easier to claim negligence than product liability.  In a negligence lawsuit, it is the defendant that must prove no harm was done due to professional malpractice.  Negligence suits remove the manufacturers and distributors from the equation and focus on the audiologist’s professional care.   Since PSAPs are in untested water, it is much more likely than a patient might charge an audiologist with negligence if the PSAP failed to deliver the anticipated result or caused harm.    The plaintiff does not have to show that the PSAP was defective only that the audiologist who fitted it was somehow negligent. 

In the case of hearing aids governed by the current FDA regulations, a chain of custody can be established from the time the instrument is made until it is fitted.  No such evidential trail exists with PSAPs and the audiologist who fits the device cannot prove that all reasonable attempts were made to ensure quality control, proper hygiene and any other procedures common to fitting a hearing aid.  The lack of proper controls should be considered by an audiologist that fits, adjusts or in any way participates in the handling of these products. It is the audiologist’s responsibility to assure that the product is safe.

 

Footnotes

 

When a HA is ordered, the mfg. ships it by common carrier (UPS, USPS, Fed Ex) from plant to customer for his/her signature.  HA is packaged to avoid tampering and carries a serial number that the mfg. can use to track the device.

At present in the US, no validation/verification procedures of this type are mandated.  But the focus of article is to suggest ways by which licensed fitters can limit their liability exposure.

Ineffective is difficult to measure and may refer to wearer perception. Nevertheless, any time a licensed professional treats a patient, the professional is potentially liable for damages.  When the licensed professional does not have control over the process, only a portion of it, any claims for negligence will be directed to the professional whether valid of not.  Again we want licensed professionals to avoid getting sued.

 

References

 

Campo P. et al. Combined exposure to noise and ototoxic substances. Eur Agency Safety & Health at Work. 2009. ISBN -13: 978-92-9191-276-6.

Guidance for Industry and FDA Staff: Regulatory requirements for hearing aid devices and personal sound amplification products. US Food & Drug Administration. Feb 25, 2009.

Medical necessity. Medicaid Toolkit. ASHA .

Warren, Grassley, Hassan and Isakson. S.670: Over-the-Counter Hearing Aid Act of 2017. March 21, 2017.

What is Product Liability? FindLaw.

 

Additional Sources Used to Prepare this Post

 

Hearing Aids and PSAPs: Making the Choice. The National Hearing Test.

How to prove negligence. Personal Injury. FreeAdviceLegal.

Perratore E. Can affordable PSAPs help you hear better? Healthafter50.com

Personal Sound Amplifier: The Sidekick. Soundworldsolutions.com

Proof of negligence in personal injury lawsuits. Personal Injury. RocketLawyer.com

 

Granville Brady AuD

Dr. Granville Brady has over 45 years’ experience as an audiologist examining patients and fitting them with hearing instruments.  He was formerly manager of hearing conservation for General Electric Company and commissioner on the New Jersey Hearing Aid Dispensers Examining Committee. He has testified in cases involving medical malpractice in fitting hearing aids and tinnitus caused by trauma. He earned a doctor of audiology degree (Au.D.) from Arizona School of Health Sciences in Mesa, AZ. Dr. Brady holds board certification (CCC-A/SLP) in Audiology and Speech Language Pathology from the American Speech-Language Hearing Association. He is a Fellow of the American Academy of Audiology.  He has been in private practice for 33 years with offices in Clifton and East Brunswick, New Jersey

 

feature image from Pharmacy Today

 

For any audiologist who watched the FTC hearings on April 15th, you will recall the mention of audiology’s “gold standard” a number of times by the members of the first on-stage panel.  For those who didn’t watch, some on the panel seemed to imply that pure tone thresholds are the gold standard for hearing.

 

The Declining Price of Gold

 

Wide use of pure tone audiometry arrived after the Second World War.  Electric audiometers were new and not all that expensive.  And the whole world needed to have hearing tests.  It was a wonderful new ball game.

Sixty to seventy years later, there are lots of folks, evidently, who think that the pure tone test is still the “gold standard”.  It gets called that in articles, postings, advertising, and by just about everyone.  Maybe it became a “gold standard” because every single person interested in hearing acuity uses it, even if many who use the test are not well versed in any nuances.

In the 70s, the standard reimbursement for 92557—a complete audiogram  (pure tone air and bone, speech reception threshold and discrimination bilaterally)—was billed and paid at $90 to $100.  Reduced fees came from Medicare (about $80) and MediCal/Medicaid (about $75). The same tests today get reimbursed at about 40-50% of those amounts.  Site of lesion tests, when administered, were then and still are paid in proportion to 92557—very meagerly.  It is interesting to consider the factors that lead to these devaluations.

Today, the “Gold Standard” is well over 60 years old.  And reimbursement for 92557 is so low that the tests are given away in order to get patients into offices.  And everyone is providing these “gold standard’ tests to anyone who walks in their door. 

 

All That Glitters is Not Gold

 

So, how golden is our standard?  A pure tone audiogram is hardly valuable enough to allow it to represent the state of “audiology science”.  It should not be thrown aside, but it also cannot continue to be the standard.

Simple observations do not support 92557 as the standard by which critical judgments and decisions about hearing loss are made.  To wit:

  • Pure Tone thresholds fail to precisely and reliability predict:
    • The site of lesion
    • The degree of difficulty the patient experiences
    • The potential success from rehabilitation.
    • Pure tones and simple speech tests fail to define:
    • Normal function other than very simply
    • Many problems within and most that are central to the cochlea
    • The cause and potential progression of disease or injury.

 

Pure tones and simple speech tests were devised from what was known about audition in the 50s and 60s and what those first simple electric instruments allowed.  This “gold standard” is analogous to the “Buster Brown” x-rays that, in the shoe stores of the 1950s, showed kids how their new shoes fit.

If patients had just a little knowledge of audition and the methods of its assessment, how many would be satisfied with air conduction pure tone thresholds?  How much is such a “gold standard” test worth?  The answer seems obvious.

 

Time for an Updated Standard

 

Since the present “gold standard” is outdated and has been so devalued as to be worth almost no reimbursement, what should audiologists do?  It would seem that the first order of business would be to reconstruct the standards to reflect the breadth and depth of what can be determined about the ear and hearing with non-invasive, “patient-friendly” tests. 

A few years ago, I experienced a sudden distortion in one ear.  Having determined it was not my car radio, I underwent a series of audiometric tests to see if the problem could be isolated.  The pure tone, speech, and immittance tests with reflexes were normal.  Central auditory tests were normal.  There were no retro-cochlear signs.  Only otoacoustic emissions indicated that the loss was cochlear—OAEs gone in one ear.  (I eventually recovered—don’t know why.)

I cannot guess how many complaining patients must have been told in the past, after a “gold standard” audiogram showed “normal” hearing, that there was nothing wrong with their hearing. 

What would you propose as a “gold standard”?  Certainly a 92557-procedure audiogram can be a starting point.  But, it cannot be the end or only point.  Patients deserve the benefit of all of the knowledge audiology has accumulated.  Our “gold standard” must also take into account reimbursement sufficient to support itself.  Third-party payers alone cannot determine or mandate our “gold standard” unless we are content to be defined by those who are not our patients or by those who use the pure tone audiogram as their only tool.

If the “gold standard” of our field reimburses so little that is administered freely to many patients and other “customers,” perhaps we shouldn’t care that others use the test in their businesses.  After all, if its use is not profitable for us, why should we care if it is not profitable to others?  Shouldn’t we, as a field supplement this outdated standard with procedures that do a better job, result in data that has more predictive value, and are reimbursed at a level that allow them to stand alone in the value arena?

If you are not doing anything other than 92557 tests, here is my question: How does your field move forward with a gold standard of such little value?

 

feature image from Penobscot McCrum