by Harvey Abrams, PhD.
Harvey Abrams PhD
“Peeling the Onion” is a monthly column by Harvey Abrams, PhD.
I participated in two events this week. One informed the other. The first event was the Federal Trade Commission (FTC) Workshop held in Washington DC on April 18th. The other was the March for Science which, in my current geographical location, took place in St. Petersburg, FL.
Now Hear This
The FTC workshop, subtitled “Now Hear This”, was convened to explore issues associated with competition, innovation and consumer protection in hearing health care and, specifically, to:
“…examine ways in which enhanced competition and innovation might increase the availability and adoption of hearing aids by those consumers who need them. In addition, the workshop will examine how to balance consumer health and safety issues with consumer interests in greater competition and innovation, and ensure consumers have access to truthful and non-misleading information about hearing health products and services.” [italics mine].
It would appear that the FTC came into this meeting with some preconceived ideas about the industry – ideas concerning the untrustworthiness of hearing health care that do not appear to be supported by any evidence that I could find on its Bureau of Consumer Protection website. For example, when I entered the key words “hearing aids” into the site’s search feature the only relevant “hit” I was able to identify was an action taken by the FTC against a hearing aid manufacturer over 20 years ago.
Stakeholder Panels
The FTC workshop consisted of presentations by invited stakeholders sitting on four different panels:
- Innovations in Hearing Technology
- Innovations in Hearing Health Delivery
- The Costs and Benefits of Hearing Health Care Regulations
- Informing Consumer Choice in Hearing Health Care. T
The panelists represented the professional community, industry, researchers, policy makers, and the consumer. In addition to brief opening remarks, the panelists were asked questions by the moderating FTC staff. As a researcher and one who values evidence-based policy making, I was struck by the number of remarks made by several panelists that represented anecdotal “evidence”, assumptions, or provocative statements unsubstantiated by existing evidence.
Without refuting each of the following statements by citing contradictory evidence or by identifying a lack of evidence (I think the readers of HHTM can easily identify the flaws), here are some examples:
- Cost is the key reason that people with hearing loss do not have hearing aids.
- “Information costs” are unusually high, and the consumer doesn’t have opportunity to try hearing aids or specific features.
- Competition does not exist at any level – more choices and “better access” will drive down prices.
- PSAPs and hearing aids are the same; the only difference is regulatory.
- PSAPs are safe and effective.
- The current FDA standards apply to just 6 companies.
- Eyeglass/contact lens industry is an appropriate model for hearing aids.
- Many websites are set up by manufacturers to trick consumers.
So Many Agencies, So Little Evidence
So, here we have a third agency, FTC, following closely behind the PCAST, NASEM, and FDA, examining issues associated with hearing health care. While the FTC hasn’t weighed in yet, would anyone be surprised if they follow the recommendations of the others (in the name of competition) to support a separate classification of hearing aids that can be dispensed without professional involvement; i.e. OTCs?
FTC’s recommendation will mean that a Presidential advisory task force and three separate agencies are recommending a significant modification to a medical device regulation designed to protect consumer safety with almost a complete absence of evidence to support the change. The only reputable study to examine the efficacy of OTCs was recently reported by Humes et al. (2017). While this research represented a well-designed and executed study, it is just one study and the generalizability of the results are limited for the reasons I identified in my last post.
If we apply what we currently know about the efficacy of OTC hearing aids based on all published studies (and/or the lack thereof), the overall assessment of the strength of the evidence would be considered “Low” by the Agency for Health Care Quality (AHRQ). A “Low” level of evidence is interpreted to mean that
“We have limited confidence that the estimate of the effect lies close to the true effect for this outcome [i.e., the outcomes of OTCs are at least equivalent to conventionally fit hearing aids]. The body of evidence has major or numerous deficiencies (or both). We believe that additional evidence is needed before concluding either that the findings are stable or that the estimate of effect is close to the true effect.”
Figure 1. My favorite sign at the March for Science rally.
So Many Audiologists, So Little Evidence-Based Practice
Recall that I participated in a second event this week – the March for Science. Unlike the atmosphere at the FTC meeting, in St. Petersburg I was surrounded by like-minded scientists, researchers, students, administrators, consumers and policy makers who value the power of data in making evidence-based policy decisions.
I’d like to think the audiology community shares in that ethic but, unfortunately, we are not completely without guilt here. We need to seriously consider if PCAST’s, FDA’s and FTC’s lack of a rigorous adherence to evidence-based policy decision-making for hearing health care is partially based on our own careless engagement in evidence-based clinical practice. For example,
- Are we consistently conducting a thorough needs-assessment for each patient?
- Are we selecting hearing aid features on the basis of those needs and not just on the audiogram?
- Are we routinely conducting speech-in-noise speech recognition testing?
- Are we appropriately conducting cognitive screening tests?
- Are we verifying our fittings with probe microphone measures for each patient, for each hearing aid?
- Are we validating our treatment with standardized outcome measures?
- Are we routinely offering post-fitting rehabilitation services?
Unless we can say “yes” to each of the above, how can we demand FDA or FTC to say “yes” to evidence-based hearing health care policies.
References
Humes LE et al. (2017). The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. Amer J Aud, 26, 53-79.
Harvey Abrams, PhD, is a consulting research audiologist in the hearing aid industry. Dr. Abrams has served in various clinical, research, and administrative capacities in the industry, the Department of Veterans Affairs and the Department of Defense. Dr. Abrams received his master’s and doctoral degrees from the University of Florida. His research has focused on treatment efficacy and improved quality of life associated with audiologic intervention. He has authored and co-authored several recent papers and book chapters and frequently lectures on post-fitting audiologic rehabilitation, outcome measures, health-related quality of life, and evidence-based audiologic practice. Dr. Abrams can be reached at[email protected]
Feature image by Ross Land/Getty
Dr. Abrams, I am concerned that those who advocate for the general public to self treat for mild to moderate hearing loss, will not understand the limitations for use, and outcomes may be hazardous to the patients health. EG How will the public know they have low frequency hearing loss, which is a marker for cardiovascular disease, stroke, and cerebrovascular disease, (which contributes to the onset of cognitive decline, and dementia). A physician who is not trained in audiological care, who advocates for OTC products may not be aware of the aforementioned risks to the patient, and the risk to the patient with and OTC product may clearly outweigh the benefit. It may be niaeve for those in hearing health care, and medical care to presume that the public are capable of choosing the appropriate technology that is capable of preventing a fall in the elderly, or lowering the risk of cognitive function decline with the use of a less effective OTC product. A major barrier to hearing healthcare care is a lack of education about hearing impairment on the part of the primary care physician, and the patient. We need to bridge the gap between what they know, and what they need to know, so that more effective risk versus benefit counseling in the exam room can take place, and the patient receives and understands the “best practices guidance” they deserve. Hearing aids in Australia are free for the equivalent of the Medicare patient, yet only three out of every 1000 visits to a primary care physicians office by the over 60-65 years patient results in a referral to an ENT or an audiologist/hearing healthcare specialist. It is not competition that drives down the cost of hearing aids, it is education that will drive up the treatment of hearing loss. I am with you all the way, Dr. Abrams.
The last sentence deserves a correction. It should read: “Competition may drive down the cost of hearing aids, but a lower cost of devices may not drive up utilization. Free is not a very good price, without appropriate education for both the physician and the patient. It is more effective “risk versus benefit counseling” by the patient’s physician, and the hearing healthcare specialist that will validate the treatment of hearing loss, regardless of severity of loss. Thus, providing the potential to improve the patients quality of life. An unregulated, uninformed, autonomous public may not be the wisest strategy for effective implementation of an OTC product. Hearing Healthcare Specialists, whether with an OTC product of an FDA approved programmable hearing aid is the best choice, especially when there is more professional, collaborative, interdisciplinary care, shared by primary care physicians and hearing healthcare providers.
…an then there’s what I call the “dresser drawer” effect. If the first aid people try is a low-performing one, they are very likely to say, “I tried aids but the don’t work,” and leave them in the drawer. That’s already a too-common outcome.
As I’ve always said, Hearing Aids fall into several types: there’s Behind-the-Ear, In-the-Ear, In-the-Canal, Completely-in-the-Canal, and Completely-in-the-Drawer. My family always said that my uncle had the In-the-Drawer type. They were completely invisible, and I never knew he had them.