Both Ends of the PSAP Spectrum: The PCAST

The impending re-regulation of hearing aids and possible changes to the 2013 FDA Draft Guidance regarding PSAPs has caused a stir within the audiology community. To gain the full perspective of the issues, we have republished, with the permission of the authors and publisher, two recent articles. On one end of the fray, the long term health and safety risks of individuals who may purchase hearing aids and PSAPs without a hearing test outweigh the well-documented access and affordability issues. Brad Stach and Virginia Ramachandran, relying on their clinical experience in large medical centers, attempt to debunk nine myths they believe are associated with the 2015 PCAST recommended guidelines. Contrast their opinions with those of Kim Cavitt. In her article, the issues of affordability & accessibility, and the opportunity those challenges present to audiologists, overshadow the risks of missing a serious medical condition when a diagnostic hearing evaluation is not completed by a patient prior to purchasing a device. Both ends of the spectrum provide evidence to support their claims and both articles warrant careful consideration.
When we think of hearing aid care, we think of our patients, the vast majority of whom are over 70 years of age. Most noticed a little bit of hearing loss years before and didn’t pursue hearing aids because they felt they didn’t need them or didn’t feel their problem was bad enough to commit the financial and other resources necessary to be successful hearing aid users. Then they reached a certain tipping point in life, and they sought us out as healthcare providers to diagnose, treat, and monitor their chronic communication disorder. We also know that there are many other patients out there who have hearing loss but do not want hearing aids at the present time.

When we think of the cost of hearing aid care, we think of the cost of the device and the cost of our time, our staff’s time, and all of the resources that our institution commits to ensuring safety, quality, and privacy for our patients. And, when we think of the hearing aid industry, we think of companies that are driving technological advances at a rapid pace, especially for such a small market. It seems that every season we are learning new and exciting ways to help our patients. We also think of the educators we know from the companies who are working hard to keep us updated on how we can best adapt their technology to our patient’s needs.

Now imagine for a moment that we are not us, that instead we are members of the consumer electronics industry. We see hearing aids as electronic devices, not as a part of a process of care for a chronic healthcare condition. We don’t see on a daily basis the otologic disease and other health conditions that impact successful care of our patients. No, what we see is a massive economic opportunity. We see an untapped market. We see millions of potential customers who are not buying electronic devices to help their hearing. And why are they not buying these devices? Well, they tell their doctors and their spouses that they are just too expensive, so it must be the cost. And it might also be that they are regulated to protect the health and safety of the customers, so it must be the government regulation. Or perhaps that regulation conspires to keep competition out of the market. Surely customers would just buy these devices for their hearing if only we could de-regulate.

Back to being audiologists, we have seen for years the presence of, but lack of traction for, what are now called PSAPs. That doesn’t surprise us. We know our patients don’t really want hearing aids until they need them. Still, the PSAP clamor is growing, as is the call for more over-the-counter (OTC) hearing technology solutions. From our patient-centered care perspective, this is at least mildly unsettling. Stated nicely, “Empirical research on the economic value of patient-centeredness and the importance of trust in the patient-physician relationship shows that a patient’s sense of feeling known, cared for, and understood can directly promote emotional well-being linked to better care, and respect and trust in the patient-physician relationship can improve health through better continuity of care, patient satisfaction, and commitment to treatment plans” (Berenson and Cassel, 2009). We certainly know this to be true of the patient-audiologist relationship as well.

PSAPs have been available over-the counter for years and haven’t had much of an impact, so what has changed?

Recently, the President’s Council of Advisors on Science and Technology (PCAST) released a report to the President of the United States on recommendations that it claims will increase access to hearing care for Americans. The report can be found at: Although the focus on hearing loss and care for our aging population is laudable, the report is based on faulty assumptions and a limited evidence base. In our opinion, the report’s recommendations are dangerous and will not result in greater benefit to our patients. Given that the council purports to support scientific recommendations, it is stunning how much the actual data are ignored in favor of what appears to be a bias toward the consumer electronics industry.

In 2009, Dr. Christine Cassel, the co-chair of the PCAST Hearing Technologies, co-authored an article in the Journal of the American Medical Association decrying the consumer-driven approach to healthcare that is the very cornerstone of the PCAST report and its recommendations (Berenson and Cassel, 2009). It is unclear as to why these beliefs in the importance of appropriate healthcare have failed to extend to patients with hearing loss. In their article, Berenson and Cassel stated, “Both patients and physicians should exercise caution before moving headlong into a strategy that attempts to make health care more efficient and effective by further increasing the pressure of competitive market forces”.

The PCAST report states that “only a fraction of consumers who need assistance with hearing obtain and use hearing aids”. This statement is factually correct and based on numerous studies. The report goes on to suggest that this is due to “high cost, complex dispensing procedures, social stigma, and performance shortfalls”. This lip service to the myriad of factors impacting consumer access to hearing care is thereafter largely ignored in deference to cost alone. The report is fraught with myths and has conclusions that somehow seem even unrelated to all of the twisting of the story.

Here is our take on the PCAST myths:

PCAST MYTH #1: Hearing care is “too expensive”
The fundamental premise on which this report is based is that hearing aids and related care are higher than they should be. There is no evidence for this, and yet the PCAST authors treat the assumption as if it is fact. For most patients, hearing loss is a chronic condition relating to aging. In fact, it is the third most common chronic condition associated with the aging process. The cost of care is typically a bundled cost of both device and services for the life of the device, around five to seven years. The cost of hearing devices and related care is substantially below the annual cost of treatment of the other chronic conditions associated with aging, such as arthritis, vision disorders, heart disease, cancer, dementia, and respiratory disorders. The costs for hearing care is a bargain compared to treatment for any of the other disorders.

The PCAST report alludes to the connection between hearing loss and other health issues in the elderly as evidence for the need for care. If, in fact this connection is true, then the value of hearing care is probably far higher than what it actually costs.

Furthermore, the PCAST cites an average cost of hearing aids, then later suggest that people can benefit from lower-cost personal sound amplification products (PSAPs). The PCAST compares the average cost of hearing aids to PSAPs instead of the entry-level costs of hearing aids, which in most cases of bundled audiologic care plus device would be under $1,000. This is significantly closer to the cost of PSAPs, which have poorer technology than entry-level devices and no audiologic care.

Likewise, the PCAST report states that Veterans Administration hospitals obtain hearing technology at a lower rate than most audiologists in the private sector, which is true. They fail to notice that the VA is the largest employer of audiologists in the nation and neglect the true cost of care, which necessarily includes audiologic services.

Comparisons are made by the PCAST of “retail” hearing device dispensers (presumably this includes audiologists working in healthcare settings) to Big Box stores such as Costco, citing lower costs in these settings. In this case the PCAST is comparing apples to oranges in that retail settings are not subjected to the public oversight and consumer protections that are inherent to the medical and healthcare communities. Audiologists are healthcare providers, working predominantly in medical settings. As such they are subject to the regulatory policies which protect consumers and include, among many other assurances, on-demand access to foreign language and American Sign Language interpreters, use of electronic medical records that meet the federal government’s requirements for meaningful use, meeting HIPPA requirements for patient privacy and billing practices, and ensuring equitable access to care for consumers of diverse backgrounds. These mandatory patient and consumer protections, which retailers are free to ignore, come with a cost.

Care costs money. The nature and extent of care that our patients receive is valuable by any standard. When stacked against the care and direct expenses of other chronic conditions of older patients, its affordability is clear.

PCAST MYTH #2: Cost is the largest barrier to adoption of hearing care
The report states that “PCAST believes that cost is the largest barrier to hearing-technology adoption”. This belief is, of course, without supporting evidence and in spite of substantial evidence to the contrary. Although market-based surveys of attitudes toward amplification suggest that affordability can be a barrier to hearing aid adoption, population-based studies that have examined income as a determinant of hearing aid acquisition or use have failed to demonstrate an association (Fischer et al., 2011; F. R. Lin et al., 2011; Popelka & Cruickshanks, 1998). In fact, the very market-based survey cited by the PCAST to support the issue of cost as a barrier (Kochkin, 2007) showed that type of hearing loss and perceived need are the largest reasons cited for non-use of hearing aids, not cost as is reported. These data have been curiously misrepresented in this report.

The PCAST also cites the National Health and Nutrition Examination Survey to suggest that people with the lowest incomes were less likely to use hearing devices. In fact, hearing aid ownership was found to be lower among only the lowest 20th percentile of households. What the PCAST failed to appreciate was that in households with higher incomes there was NO TREND for hearing aid ownership (Bainbridge and Ramachandran, 2014). Once above the poverty level, income does not impact access to hearing care. Except for the poorest consumers, the costs of bundled hearing devices and audiologic care are not too high to access and are in line with other services provided by healthcare professionals. When patients are ready for hearing care, they allocate their resources accordingly.

PCAST MYTH #3: Reduction of cost will increase patient use of hearing technology
Data from nearly every international study where hearing care is heavily subsidized, and therefore low cost or free, show that hearing aid uptake remains low among people with hearing loss. (Barto et al., 2001; Smeeth et al., 2002; Ward, Lord, Williams, & Anstey, 1993). Reduced cost in these countries does not increase access or use.

At Henry Ford Hospital, where insurance coverage for hearing care is the norm emerging from the auto industry, we were able to examine the consumer behaviors regarding hearing care with cost controlled via insurance coverage (Ramachandran et al., 2011). We found that:
  • Full insurance coverage reduced the age and degree of hearing loss at which patients obtain hearing aids by 7 years and 5 dB, respectively.
  • Partial insurance coverage (i.e. substantial reduction to the patient in the cost of devices) had NO IMPACT on the age or degree of hearing loss at which patients obtained hearing aids.
Short of giving them for free, reducing the cost of hearing devices does not lead to greater uptake. The goals of the PCAST to decrease cost by “opening the market” will not motivate consumer use of hearing aids.

This may seem counterintuitive to the consumer electronic community, because the economic theory on which they rely is based on the assumption that consumers behave rationally with regard to their healthcare decisions. Anyone who understands healthcare knows that is not a reasonable assumption, and the evidence bears this out.

PCAST MYTH #4: Simply obtaining hearing aids leads to use and benefit
There is clearly an underlying assumption in the report that merely having access to cheaper hearing devices will result in consumer benefit. For this to occur, people must use their devices, and the devices must provide appropriate amplification and treat their communication disorder.

In our study of patients at Henry Ford Hospital who obtained hearing aids with insurance coverage, people who received hearing aids for free via full insurance coverage came back for audiologic follow up significantly less often than patients who paid for their hearing aids, even when technology was kept constant for both groups (Ramachandran et al., 2012). This suggests that many patients were not using their hearing aids when they did not pay for them themselves, likely because they obtained them at an earlier age with less hearing loss than the other group. Access to cheaper or free devices does not guarantee use and may even increase non-use of devices that are dispensed under models that promote “cheap” devices.

The question of benefit from hearing devices is not actually even considered by the PCAST report. One recommendation of the study is to unbundle services and have patients forgo the audiologic care needed for effective use of hearing devices. Any audiologist who works in clinical practice, and most consumers, are aware of the need for audiologic care in making hearing technology work for the consumer. This includes people with mild-to-moderate, age-related, sensorineural hearing loss whom the PCAST mistakenly appears to believe can be easily treated with simple amplification devices.

PCAST MYTH #5: Eliminating comprehensive audiologic evaluation and medical clearance will be safe for consumers
The PCAST report focuses on acoustic neuroma and cerumen as the major areas of medical concern for patients and calls “anecdotal” other medical concerns where hearing loss is a presenting symptom. The reality is that hearing loss is a symptom that can result from a number of medical disorders that can have serious complications. Disorders, of course, include occlusion of the ear canal due to wax or other debris, infection of the ear canal, middle ear, or inner ear, cholesteatoma, mastoiditis, meningitis, autoimmune disease, Meniere’s disease, otosclerosis, acoustic neuroma, vestibular schannoma, meningioma, glomus tumor, multiple sclerosis, or ototoxic medication. To brush off the need for these disorders to be detected and treated medically is negligent and profoundly dangerous to consumers.

The PCAST further recommends the use of online and other non-traditional forms of testing for hearing sensitivity. While these forms of hearing testing may provide general information about hearing sensitivity, they cannot provide accurate information about the multitude of often serious and treatable medical conditions for which hearing loss is a symptom. In order to protect consumers from misdiagnosis they require complete audiologic evaluation rather than merely a test of hearing sensitivity.

Berenson and Cassel (2009) describe how the recommendation such as those of the PCAST can result in poor quality of medical care for consumers. “Thus, in a consumer-directed system that promotes continuous shopping at the point of service, consumers will likely place little emphasis in their purchasing decision on these attributes relative to the more technical aspects of price, disease-specific quality, patient satisfaction, and service …such an atomized approach to how patients obtain health care will undermine other essential components of quality, less amenable to marketing and measuring, such as ability to diagnose unusual conditions, reassurance during difficult illnesses, patient partnership around informed decision making, and coordination of care.”

PCAST MYTH #6: Patients can self-diagnose, self-treat, and self-monitor hearing loss
The report states that “hearing treatment and tests meet the FDA requirements for OTC products, which are that consumers should be able to self-diagnose, self-treat, and self-monitor the condition.” Self-diagnosis and self-treatment is likely to be profoundly difficult for people with hearing loss. Anyone who has ever worked clinically understands the lack of connection between a patient’s perception of hearing loss and the reality of the hearing sensitivity, especially in the configured losses that most older patients have. Data from the National Health and Nutrition Examination Survey (Bainbridge and Ramachandran, 2014) demonstrate that a substantial portion of people self-report levels of hearing ability that differ greatly from their measured hearing ability.

In describing why consumer-directed care may be bad for patients, Berenson and Cassel state “Society still looks to professional values to add a measure of confidence in an interaction in which the consumer (or patient) is at a disadvantage because of the vulnerability of the illness state or the simple fact that few patients can master the complexity of knowledge necessary to be a totally informed shopper”. This situation is true of the hearing healthcare arena where, without professional intervention, patients are ill-equipped to understand their degree or type of hearing, the consequences of untreated medical conditions, and whether the type of over-the-counter hearing technology promoted in the PCAST recommendations would be a viable and useful treatment for a given patient.

PCAST MYTH #7: Providing over-the-counter access will be safe for consumers
The report recommendations were provided for those consumers with “age-related, progressive, mild-to-moderate hearing loss” and “recognizes that many Americans have severe hearing impairment or deafness from congenital or illness/injury causes” but that these recommendations do not address these categories of need. Indeed, these recommendations do not address the extensive needs of these consumers, but what is to prevent these consumers, including children, from access to the over-the-counter devices?

It is commonplace in clinical practice to find that consumers greatly underestimate the degree of hearing loss that they have. Leaving consumers to fend for themselves to guess at their degree and type of hearing loss can lead to over-the-counter devices being used for populations for whom they were not intended. For adults with greater degrees of hearing loss, under-amplification and under-treatment may mean that they are at higher risk for depression, falls, and cognitive decline.

Children inappropriately treated with over-the-counter devices at likely to be at risk for speech or language delays, poor school performance, and/or cognitive delay. For both adults and children, over-amplification can result in hearing loss caused by excessive sound-level exposure from the device.

PCAST MYTH #8: Hearing loss is the same as vision loss
Throughout the report, the PCAST tries to equate vision loss and care to hearing loss and care. For example, the PSCAT erroneously compares mild-to-moderate sensorineural hearing loss to vision loss. This comparison would be correct for conductive hearing loss, but it is incorrect for sensorineural hearing loss. Sensorineural hearing loss is more like low vision disorders such as glaucoma or macular degeneration, which require professional rehabilitation interventions to manage.

The PCAST made two major recommendations to have the FTC develop rules about making hearing test results available to patients. We are not aware of any state dispensing laws that do not already require that.
PCAST MYTH #9: The hearing aid industry is a closed market
The report talks about Federal and State regulations that “appear to discourage potential new entrants” into the hearing aid markets. There are no such barriers. New entrants would simply have to comply with regulations intended to safeguard our patients.

Final Thoughts
In addition to the myths described above, the report relies on numerous glaring, and frankly, amateurish misunderstandings about hearing loss and its impact on communication function, hearing aids and their impact on improving hearing sensitivity, and the role and functions of hearing care providers in the hearing care treatment process.

In our opinion, the recommendations from this report are not about better access and affordability for our patients. Rather they appear to be about deregulating the industry so that others beside current hearing aid manufacturers can have easier access to patients without being “burdened” by the protections currently in place for their safety and benefit. Buyer beware.    
Virginia Ramachandran, Au.D., Ph.D., is Education & Training Specialist, MidAmerica Region, Oticon, Inc. She is a former senior staff audiologist and research coordinator in the Division of Audiology, Department of Otolaryngology – Head and Neck Surgery of the Henry Ford Health System in Detroit, Michigan.

Brad A. Stach, Ph.D. is Director of the Division of Audiology, Department of Otolaryngology-Head and Neck Surgery, of the Henry Ford Hospital in Detroit, Michigan.  He also serves as a consultant for Audiology Clinical Education at Wayne State University Department of Communication Sciences and Disorders. Dr. Stach has served in audiology leadership and clinical positions at The Methodist Hospital of Houston, Georgetown University Medical Center, the California Ear Institute at Stanford University, the Nova Scotia Hearing and Speech Clinic, and the Central Institute for the Deaf. He is a founding board member of the American Academy of Audiology and has served as its President and the Chair of its Foundation’s Board of Trustees.  Dr. Stach is the author of a number of scientific articles, books, and book chapters and is the Audiology Editor-in-Chief for Plural Publishing.

The opinions and assertions presented are the private views of the authors and are not to be construed as official or as necessarily reflecting the views of the American Academy of Audiology, Henry Ford Hospital or Oticon.

This article originally appeared as a three-part series at the Hearing Health and Technology Matters (HHTM) blog in March, 2016. HHTM granted permission for this article to be republished by Audiology Practices.
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