USPSTF Recommendations for Hearing Loss Screening in Asymptomatic Older Adults—A Case of Missing Evidence and Missing Treatment Options

In the new US Preventive Services Task Force (USPSTF) recommendations for screening for hearing loss in older adults, Krist et al¹ report that there is insufficient evidence to assess the balance of benefits and harms for hearing loss screening in asymptomatic adults aged 50 years or older in primary care settings (I statement).² These new recommendations are unchanged from the prior 2012 statement.³

The importance of this topic is underscored by the large number of older adults with a clinically significant hearing loss. It is the third most common chronic condition in the United States,⁴ with 34 million adults aged 50 years or older having hearing loss in both ears and 60 million having loss in at least 1 ear.⁵ For every 13 adults aged 50 to 59 years, 1 will be impacted. For adults 70 years or older, it is 2 of every 3 adults.⁵ Within the next 40 years, the number of adults in the United States who have hearing loss is expected to increase nearly 2-fold because of the increase of the aging population.⁶

In assessing benefits and harms of screening, the USPSTF considers several key questions within an established analytic framework.^1,2,7 These questions start with identification of the population at risk (ie, asymptomatic adults aged ≥50 years), with particular focus on the identification of research gaps and health inequities for Black, Indigenous, and Hispanic/Latino populations.⁸ For screening tests, important considerations include the availability and validity of the screening tests, as well as any adverse effects of screening. Similarly, evidence regarding the efficacy and adverse effects of treatment are also considered. Other key questions focus on the impact of both screening and treatment on important outcomes of interest, both intermediate and downstream.

With hearing loss screening, some of these questions have clear answers. For example, the validity of various screening tests is well documented, and hearing aids (the most common form of hearing loss treatment) can improve speech comprehension.

Yet other important research gaps remain. The first gap relates to our understanding of how screening and treatment impact patient outcomes. For these key questions, the USPSTF distinguishes between 2 types of outcomes, intermediate outcomes and health outcomes.^1,2,7 Much as it sounds, intermediate outcomes are those that may be impacted by the screening program or by treatment but are proximal and may not be perceptible to patients (eg, change in blood pressure). By contrast, health outcomes are more distal and are the outcomes that may be directly felt or experienced by patients. Functional status and quality of life are important examples of health outcomes. Most current studies of hearing loss screening or treatment focus on hearing-related quality of life.^1,2 This is an important metric, although it is still proximal. Overall quality of life measures will be important to consider in future studies to give a broader picture of how hearing loss screening or treatment may impact the well-being of patients. Additionally, hearing loss has recently been implicated in other downstream health outcomes, including dementia.⁹ Whether hearing loss treatment can delay these outcomes is unknown, but randomized clinical trials assessing cognitive decline are underway.¹⁰

Furthermore, most current studies fail to document important adverse outcomes of screening, including failure to seek additional work-up or treatment (eg, hearing aids) after a positive screening test. This research gap is critical, as it highlights the largest barrier to be addressed regarding hearing screening. For any health condition, establishing the evidence for a screening modality is in large part predicated on screening leading to successful treatment for the condition. But what if the treatments for the health condition are in fact widely unavailable, inaccessible, or unaffordable? Trying to understand the effectiveness of screening in this case may be considered challenging at best or perhaps even premature.

Unfortunately, the current state of hearing care for adults in the US is rife with such accessibility issues. Obtaining hearing aids costs a mean of $4700, requires multiple clinic-based appointments with a specialist, and is not covered by Medicare or by most insurers. Therefore, for many US adults, this out-of-pocket cost for a pair of hearing aids could represent their third-largest material purchase in life, after a house and car. Unsurprisingly, rates of hearing aid use among adults are low, with less than 20% of adults with a hearing loss reporting hearing aid use.¹¹

Over the past 5 years, efforts from both the National Academy of Medicine (NAM)¹² and the White House President’s Council of Advisors on Science and Technology (PCAST)¹³ have begun to consider the regulatory and legislative barriers limiting hearing care accessibility in the US. These efforts have been spurred by the growing scientific understanding of the association of hearing loss with dementia risk, loneliness, and other critical health outcomes and the role that more accessible hearing care could have in potentially mitigating these adverse outcomes. Fortunately, efforts from these advisory bodies^12,13 have begun to yield tangible legislative gains that are poised to potentially reshape the accessibility and affordability of hearing care in the years ahead.

At present, one of the key reasons for hearing aids being so expensive is that federal hearing aid regulations enacted in 1977 allow for hearing aids to be sold only through a licensed supplier. At that time, these regulations made sense, given that analog hearing aid technologies available then had to be provided through a licensed supplier to ensure safety and effectiveness. However, these arguments no longer hold after a half century of technological progress. Reports from both PCAST in 2015¹³ and NAM in 2016¹² led to bipartisan federal passage of the Over-the-Counter Hearing Aid Act of 2017,¹⁴ which instructs the Food and Drug Administration (FDA) to create a regulatory classification for hearing aids that would be explicitly available over-the-counter to consumers and would meet performance standards to ensure safety and efficacy. Release of these FDA regulations for over-the-counter hearing aids, which were set to be released by August 2020 but are now temporarily delayed owing to the COVID-19 pandemic, will increase the accessibility and affordability of hearing aids as both established (ie, existing hearing aid manufacturers) and new companies (eg, consumer technology companies, such as Bose) enter the over-the-counter market.

Importantly, while market strategies that can lead to affordable hearing aids are critical, ensuring that individuals can access the professional hearing care services of an audiologist to address their hearing needs through technologies and other rehabilitative strategies is equally important. Similar to outdated hearing aid regulations, historical precedents, this time regarding Medicare coverage of hearing care services, have prevented many older adults from being able to access audiological care in the US. When Medicare came into existence in 1965, options for hearing loss treatment were in their nascence, hearing aids were of limited efficacy, and hence hearing aids and audiological rehabilitative services for hearing loss were listed as statutory exclusions for coverage. Fast-forward 55 years later, and this stipulation persists despite a half-century of progress in the effectiveness of hearing aids and a sea-change in our understanding of the adverse health outcomes associated with hearing loss. At present, audiologists can only be reimbursed by Medicare and many other insurers for performing diagnostic hearing testing but not for any subsequent rehabilitative services to counsel, teach, and care for patients with hearing loss. As a result, many audiologists derive much of their income through selling hearing aids, wherein the costs of their services are bundled into the cost of the hearing aid that is borne by patients.

Fortunately, spurred by the NAM report,¹² efforts in Congress have also begun to increasingly focus on the legislative measures needed to amend these statutory prohibitions in Medicare. Importantly, some forward-thinking bills have been able to balance the seemingly conflicting goals faced by any policy maker of wanting to expand coverage with the reality of limited resources. By leveraging the market changes that will come with the Over-The-Counter Hearing Aid Act,¹⁴ one such bill, the Elijah Cummings Lower Drugs Costs Now Act (HR 3)¹⁵ was passed by the House of Representatives in January 2020 and is planned to be considered again in the 2021 session of Congress. This law, if passed, would provide Medicare coverage of audiological rehabilitative services for all beneficiaries. However, hearing aid costs would largely be borne by patients, which could become less burdensome in the future, given that over-the-counter hearing aids are expected to be available in a comparable price range to currently available wireless earphones.

Only in the context of these fundamental changes to hearing health care can the question of screening programs be addressed. That is because, to be successful, screening programs must accomplish 2 goals. First, they must validly and reliably detect health conditions earlier than would have been detected with routine care. For hearing loss, this is clearly the case, as borne out by the evidence documented by the USPSTF in this new recommendation^1,2 and in prior reports.³ Where the evidence has routinely fallen short is with the second marker of a successful screening program—that early identification makes treatment easier or more effective in reducing morbidity. Only now that hearing care is poised to be more accessible and affordable for US adults can we realistically begin to answer this question.

Published: March 23, 2021. doi:10.1001/jamanetworkopen.2021.0274

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Deal JA et al. JAMA Network Open.

Corresponding Author: Frank R. Lin, MD, PhD, Cochlear Center for Hearing and Public Health, Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, 2024 E. Monument St, Ste 2-700, Baltimore, MD 21205 (flin1@jhmi.edu).

Conflict of Interest Disclosures: Dr Lin reported receiving personal fees from Frequency Therapeutics and Caption Call outside the submitted work and serving as the director of a public health research center funded in part by a philanthropic gift from Cochlear Limited paid to the Johns Hopkins Bloomberg School of Public Health. No other disclosures were reported.