Audiology Response to the FDA Reauthorization Act of 2017 : The Hearing Journal

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Audiology Response to the FDA Reauthorization Act of 2017

Weinstein, Barbara E. PhD

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The Hearing Journal 71(12):p 8,9, December 2018. | DOI: 10.1097/01.HJ.0000550398.82271.0d
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The audiogram continues to be the holy grail of audiology despite having the World Health Organization's International Classification of Functioning, Disability, and Health model, which clearly shows how loss of audibility (or auditory integrity) does not directly translate into an individual's communicative ability and functions in a particular context (WHO, 2001;Hearing Journal. 2018;71(9):38 Stated differently, instead of the severity and configuration of hearing loss, the self-reported degree of “hearing access,” as described by Pam Millett, PhD, in the September 2018 issue of The Hearing Journal, is an excellent descriptor of functional communication that motivates hearing health behaviors—and a framework that professionals should consider adopting. A multifactorial domain of function, hearing access depends on these interconnected variables: auditory integrity, amplification integrity, individual factors, and listening environment.

Table 1:
Attitudes Likely to Lead to Positive Help-Seeking Behaviors (from Ear Hear. 2016 May-Jun;37(3):324).

Dependence on the audiogram is old-school and leads to a one-size-fit-all approach to hearing care. And with the passage into law of Section 709 of the FDA Reauthorization Act of 2017 (FDARA) that includes the Over-the-Counter (OTC) Hearing Aid Act, we must abandon this way of thinking. A maturing of our philosophy as audiologists should emerge from the disruptions presented by the FDARA, with an emphasis on the value added of engaging with audiologists.


The FDARA was designed to balance consumer access to new technologies, with protections to assure safety and efficacy of OTC hearing aids. Under the specter of this legislation, audiologists should be taking a fresh look at the current service delivery models as suggested by respondents to the recent readership survey on the expected impact of OTC hearing aids conducted by The Hearing Journal (Hearing Journal. 2018;71(9):26 I agree with Ian Windmill, PhD, that we should be reframing the intervention process away from hearing aids towards amplification in general (Hearing Journal. 2018;71(9):26 Hearing aid adoption is considered a risk proposition, so it's time to up our game with an evidence-based, best-practice model to improve patient satisfaction (Hear Rev. 2018).


I also urge us to consider reframing our professional image and engaging in more counseling and advocacy regarding the contribution of hearing to one's overall well-being. The 2017 OTC Hearing Aid Act should be viewed as a chance to open the door for reimbursement for services offered by audiologists (JAMA. 2018 Oct 23;320(16):1641). It can be viewed as a wake-up call to link hearing health to wellness and make hearing care solutions more accessible, agreeable, tangible, and transparent.

The OTC consensus statement prepared by the professional associations in the field included five recommendations relating to product requirements and labeling, all under the guise of consumer protection ( Regrettably, the recommendations focused on the technology rather than the psychosocial value added by engaging with an audiologist. Barriers to uptake of hearing care and non-use of purchased hearing aids were not stressed in the document either. Lack of attention to the importance of these issues has been and continues to be the Achilles’ heel of our profession.


Before purchasing any hearing care technology, people with hearing loss deal with psychosocial issues that audiologists must help address and resolve. These issues include the need to overcome feelings that they hear well enough, the sense that they have other more serious health priorities, and the perceived internal and external stigma they associate with hearing loss (Hearing Journal. 2018;71(9):18 A recent study found that most adults who have hearing difficulties typically delay seeking treatment and hearing aid use for an average of 8.9 years (non-white participants took 15 years to adopt hearing aid use after candidacy, while whites took 8.6 years; Ear Hear. 2018; Aug 6). The majority of potential candidates for hearing services postpone early treatment of hearing loss—and this is where our advocacy and expertise should come into play.

The audiology community should focus its energy on upgrading hearing health literacy, understanding help-seeking delays, and incentivizing healthy hearing. The evidence is clear: Significant high-frequency hearing loss combined with higher levels of self-perceived hearing-related activity limitations and/or participation restrictions are factors that influence an individual's decision to seek help for hearing difficulties (Trends Amplif. 2010 Sep;14(3):127; Ear Hear. 2018; Aug 6). Other relevant factors include social pressure, physician recommendation, and other's positive or negative experience with hearing aids (Am J Public Health. 2011 August; 101(8): 1449). We must heed Fischer and colleagues’ reasoning that if we fit hearing aids too early, patients may not see substantial benefits to offset the time, effort, and cost involved (Am J Public Health. 2011). Similarly, waiting too long is problematic as we run the risk of patients establishing compensatory mechanisms that may hinder the acceptance of hearing health care interventions. We must begin to leverage emotion science to mobilize decision-making in hearing health care.


Thanks to public health efforts, the behaviors/symptoms associated with costly chronic conditions such as heart disease and dementia are well known. Sadly, the signs of hearing loss (e.g., missing the thread of a conversation, struggling to understand speakers on television or radio and accented speakers, or withdrawing from a conversation) are less understood and rarely an impetus for considering a hearing test or learning about available solutions. Many stakeholders are not aware that timely diagnosis is a prerequisite for getting maximum benefits from audiologic interventions.

With regard to help-seeking among patients, studies have concluded that hearing care providers should direct their efforts to incentivizing this behavior and helping those with hearing loss and their families overcome personal and societal barriers affecting the decision to use hearing aids (Am J Public Health. 2011; Ear Hear. 2016 May-Jun;37(3):324; Ear Hear. 2018; Aug 6). Saunders and colleagues suggested that professionals should develop strategies that promote help-seeking and optimize self-efficacy as well as the perceived benefits of hearing health care interventions. Above all, we should offer a hearing solution to individuals whose hearing loss affects their ability to communicate. The decision to offer hearing aids should be based on need rather than the audiogram (Int J Audiol. 2015;54(11):786). Table 1 lists the attitudes consistent with help-seeking that we should attempt to leverage. As I have said in the past and will underscore again: The future is now.

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