In their recent op-ed, U.S. Sens. Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) expressed concerns over the large gap between the prevalence of age-related hearing loss and hearing aid adoption and use (JAMA Intern Med. 2017 http://bit.ly/2mNjNHe). They argued that the lack of routine screening for age-related hearing loss, social stigma associated with hearing aid use, and the regulation and sale of hearing aids are to blame for this disparity. Finally, they made the claim that stakeholders, including policymakers, consumer advocates, and researchers, are focused on reforming the market to expand access to hearing aids.
Their “Viewpoint” focused on the access to hearing aids and affordability of hearing technologies. They also described the rationale behind their bipartisan legislation, the Over-the-Counter (OTC) Hearing Aid Act of 2016, submitted to the 114th Congress. The goal of their proposed bill is to fix a purported broken market for hearing aids via a policy change.
On March 2017, Sens. Warren and Grassley, along with Sens. Maggie Hassan (D-N.H.) and Johnny Isakson (R-Ga.), introduced the OTC Hearing Aid Act of 2017 that would make certain types of hearing aids available over the counter to Americans with mild to moderate hearing impairment. A companion bill led by Reps. Joe Kennedy III (D-Mass.) and Marsha Blackburn (R-Tenn.) was also submitted.
PURPORTED DELIVERY SYSTEM PROBLEMS
Concluding that the problems in the hearing aid market stem from the current hearing aids regulations and end-user costs, Warren and Grassley said that access to innovative and low-cost hearing technologies must be part of a policy response to untreated hearing loss (JAMA Intern Med. 2017 http://bit.ly/2mNjNHe). They argued for creating a new category of OTC hearing aids for adults with mild to moderate hearing loss and for minimizing the patchwork of state laws governing access to hearing aids. However, it is our view that they failed to consider what scholars of the sociology of science and science technology refer to as “the social construction of technology” (SCOT; Pinch & Bijker. In: Bijker & Hughes, eds. MIT Press, 1987).
Simply put, a key consideration for SCOT analysis is the nature of the relevant social groups (RSGs) to which a product (hearing aid) is being targeted, the characteristics of these groups, and the representatives of these groups in the action arena that eventually shape the product. It is well accepted that hearing aids have undergone rapid technological advances—from the “non-electronic ear trumpet” to the modern day digital devices (Ear Hear. 2000;21:625 http://bit.ly/2mNqYPQ; Trends Amplif. 2007;11:31 http://bit.ly/2mNe9ou). Throughout their evolution, miniaturization has been the driving force behind hearing aid design. But is the goal of miniaturization in the best ergonomic interest of the typical end user?
CONSTELLATION OF STAKEHOLDERS
In evaluating the social forces behind the pressure toward miniaturization using SCOT analysis, the “design stakeholders” or the constellation of players in the manufacturing enterprise must be considered. Audiologists have an important role in the social dimension of hearing technology design; they are the potential point of human contact between a hearing-impaired individual and his or her hearing aid. Audiologists serve as the “social mediators” of delivering the benefit of the hearing aid. In contrast, the “technology geeks” (a.k.a. the engineers) speak the language of signal and noise, and deal with technical details such as referring to signal capture, compression, and processing of algorithms to set sound gains across frequencies, and to minimize “harmonic distortion” (Ear Hear. 2000 http://bit.ly/2mNqYPQ). From the perspective of the engineers, central to the user experience is overcoming the limitations of background noise signal-transduction, as well as improving digital wireless connectivity of hearing aids (Trends Amplif. 2007 http://bit.ly/2mNe9ou). However, engineers must work with hearing health professionals to develop devices that meaningfully connect patients with the real world.
Another relevant group involved in hearing aid design is the Hearing Industries Association (HIA), whose members are motivated to increase their market share by removing perceived barriers to greater acceptance of hearing instruments (Hearing Journal. 1990;43:17). Notably, the U.S. government also has an important role to play in enforcing regulation, safety, efficacy, and truth in advertising.
In accordance with a SCOT analysis of the hearing aid industry, the perspectives of the user and the non-user must also be considered. While designed to rehabilitate an invisible impairment, hearing aids visibly mark and, some might argue, even socially disable users. The trend toward miniaturization contributes to the invisibility of hearing loss. This in turn leads to marginalization and withdrawal of people with hearing loss because of fear of being found out (Ann Hist Comput. 2011;33:24 http://bit.ly/2nexuu4). Does the pressure to downsize stem from the social stigma of hearing aid use? Does the miniaturization of hearing aids contribute to the stigmatization of hearing loss? Or does the legacy of social stigma represent an outdated social pressure hindering the advancement and acceptability of the technology? A small survey we recently completed of experienced hearing aid users revealed that smaller is not always better for certain relevant user sub-groups.
According to data from MarkeTrak III, obstacles to market growth (the non-user RSG) include:
* low satisfaction with devices;
* negative image and questionable value associated with devices;
* social stigma;
* under-recommendations by physicians and audiologists; and
* affordability (Hearing Journal. 1993;46:20).
If non-user pressures drive the technology toward miniaturization, but the onset of miniaturization does not improve value propositions for actual users, the non-user and hearing-impaired elderly RSGs come into direct conflict. Further, these pressures may cast doubts on the reasons listed by Warren and Grassley for reforming the hearing aid market (Table 1).
CHALLENGES TO THE RSG
The “design stakeholders” face various challenges in their quest for miniaturization. Engineers need to work with audiologists and hearing scientists to ensure that patient benefits are linked with hearing technology (Trends Amplif. 2007 http://bit.ly/2mNe9ou). The HIA may need to pin down a sense of user value proposition and identify sources of satisfaction and discontent among users. The history of the stagnant hearing aid market remains an elusive quest to match user satisfaction, with the value proposition of hearing aid use—namely, improved hearing and all the attendant benefits of having a sense, once lost, restored. The latter considerations may be more important than the perceived benefit of convenience and enhanced physical accessibility motivating the actions taken by Warren & Grassley (PCAST, 2015 http://bit.ly/2mNanvd; NASEM, 2016 http://bit.ly/2b2VlvY; JAMA Intern Med. 2017 http://bit.ly/2mNjNHe; J Am Acad Audiol. 2016;27:441 http://bit.ly/2nemywG). In fact, as Chandra and Springfield noted in their qualitative study of internet-based hearing aid delivery, professional guidance and expertise are valued and needed to navigate the complexities of hearing aid use, according to experienced hearing aid users. In contrast, in their placebo-controlled, double-blind randomized clinical trial comparing the outcomes between OTC service-delivery model and the best-practices delivery model, Humes et al. concluded that further research is required before a conclusion can be drawn on the efficacy of OTC service-delivery models (and devices) and whether they actually increase accessibility and affordability of hearing aids (Am J Audiol. 20171;26:53 http://bit.ly/2newGp2).
Given the complexity of the issues surrounding hearing health care for people with age-related hearing loss, a solution may lie in Malcolm Gladwell's story of the insight that revolutionized the tomato sauce industry: There is no perfect tomato sauce, but rather a perfectible selection of sauces. Perhaps we have been asking the wrong question. The question may not be how to change the market to promote accessibility and affordability, but how to optimize it for many hearing aids.