Editor's Note: Dr. Humes provides the author's commentary while Dr. Dhar gives the reader's response.
Millions of older Americans suffer the consequences of untreated mild-to-moderate sensorineural hearing loss. Although roughly 40 percent of Americans over age 60 have enough hearing loss to cause communication difficulties, only about 25 percent of these older adults seek help for their hearing loss and purchase hearing aids. Moreover, consumer survey information from the hearing aid industry over the past 30 years indicates that this situation has remained relatively unchanged.
Recognizing the critical need to explore ways to improve the accessibility and affordability of hearing health care, the National Institute on Deafness and Other Communication Disorders (NIDCD) invited a group of experts from different backgrounds to participate in a face-to-face meeting, review the available data, and develop strategies for progress. The working group identified a long list of research needs, which became the basis for a series of Requests for Applications (RFAs) for grant funding from the NIDCD (Ear Hear. 2010;31:2 http://bit.ly/2nclJp9).
Both authors were fortunate to have been invited to this 2009 NIDCD working group and participate in the exchange of information at that meeting. After returning home and mulling over the many options that could be pursued, the first author settled on the development of a randomized clinical trial (RCT) to evaluate two different service-delivery models: (1) the existing audiology-based best practice model; and (2) a consumer-decides model, which would be central to several over-the-counter (OTC) service-delivery models discussed at the NIDCD workshop. With repeat submissions and expert guidance from the late Gordon B. Hughes, MD, then overseeing NIDCD's Clinical Trials Program, this RCT was eventually funded. After considerable pilot testing of various aspects of the protocol, the RCT was initiated in 2012, and the results have just been published in the American Journal of Audiology (Am J Audiol. 2017 Mar 2:1 http://bit.ly/2nc2koB). The three primary findings from this study can be summarized as follows: (1) hearing aids provide efficacious benefits to older adults with mild-to-moderate hearing loss when delivered via audiology best practices; (2) a particular instantiation of a consumer-decides OTC hearing aid provision model was also efficacious, and the observed benefits were largely on par with those noted in using the best practices; and (3) the purchase price of the hearing aids, either $600 or $3,600 a pair, did not affect measured outcomes.
To our knowledge, this is the first ever placebo-controlled, double-blind RCT of hearing aid benefits in older adults to be published in peer-reviewed literature. While we are proud to be the first, we are also disappointed that this is the case. Such RCTs are only the first of many steps needed to achieve the “gold standard” of clinical evidence in support of the benefits provided by hearing aids to older adults. Typically, the “gold standard” is a systematic review and meta-analysis of several RCTs. Clearly, the recently published RCT is a small initial step in what we hope will be a new road to progress on this important issue.
The lack of RCTs addressing this basic clinical problem has consequences not only in the efficacy of hearing aids or the service-delivery models used to provide them, but also in other far-reaching issues. Fan-Gang Zeng, PhD, noted, for example, that the lack of such evidence regarding hearing aid efficacy likely underlies the absence of Medicare coverage of hearing aids (Hearing Journal. 2016;69:22 http://bit.ly/2nc8Coc). Further, the U.S. Preventive Services Task Force, following a systematic review of the evidence pertaining to support for hearing screening in the elderly, cited that one reason for their inability to support widespread hearing screening was the lack of evidence on effective treatment being available to those who failed the screen (Ann Intern Med. 2012;157:655 http://bit.ly/2nc7W1P).
We hope that the recently published RCT encourages others to pursue similar studies and their publication in peer-reviewed journals. Importantly, the NIDCD, which provided the impetus for the recently published RCT, has announced that further research on the accessibility and affordability of hearing health care will remain a centerpiece of their strategic plan for 2017-2021 (See Priority Area 4 in “Hearing and Balance Research” of that strategic plan). In an effort to facilitate the development of additional RCTs in this area, the recently published RCT was published as “open access” for all to review freely. Important supplemental materials are also available online, including the full clinical protocol, most of the data collection forms, and a video used to orient the participants in the OTC branch of the RCT. The raw data have also been made available. Open access and transparency are fundamental to continued progress in this area. In the end, we hope that this RCT will soon be one of many addressing this important problem confronting millions of older Americans.
As the author points out, this RCT has to be the first of many steps before we can put our full confidence in alternate models of delivering hearing aids or other forms of amplification devices. Perhaps the need for this RCT and the resultant publication is the most important of all the points made in the original publication and this commentary. The fact that we do not have evidence built on the highest scientific standards to inform health care providers, patients, and policymakers is perhaps the greatest concern. This lack of evidence has, in many important ways, led to the current state of hearing health care, with its poor patient uptake and resultant proliferation of mal-effects of chronic hearing loss. So, this reader congratulates the study team for getting us started.
The debate will probably gravitate conveniently towards whether delivering hearing aids and other amplification devices without the involvement of an audiologist can be efficacious. These results certainly show that alternate delivery models can indeed be efficacious. However, readers should remember the meticulous controls with which this study was conducted. The quality, form factor, look, feel, and everything else about the device were identical for all arms of the study. This exact control of the hardware, comfort, and signal processing will almost never be exercisable in the wild. Thus, it would be improper to imagine that alternative models of device delivery will always be efficacious, regardless of whether the device meets the minimum quality standards. The other side of the argument, of course, is that alternate delivery models can be efficacious when they are not sabotaged by an inferior product, lack of training materials, or foisted on the wrong candidate.
Today hearing aids are delivered, almost exclusively, through legally regulated channels involving audiologists and other licensed professionals. The number of these professionals in practice today does not even come close to meeting the demands of those with significant hearing loss. So, if someone waved a magic wand and everyone with hearing loss picked up a phone to make an audiological appointment tomorrow morning, nothing short of pandemonium would ensue. Just from this mismatch between potential demand and available supply of hearing health care professionals, we can arrive at only one conclusion: We have to be creative in expanding the reach of hearing health care without compromising the quality of care delivered. It seems inevitable that automation and multiple delivery channels will be needed to satisfy the nation's upcoming demand for hearing health care. The best strategy, in this reader's opinion, would be to position ourselves as the staunchest advocates of those with hearing loss. Demand policy that is based on evidence. And strive to cast the widest possible net for hearing health care.