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Over-the-Counter (OTC) Hearing Aids – Part 1

Over-the-Counter (OTC) Hearing Aids – Part 1

by Mark Ross, Ph.D.

Editor: The topic of over-the-counter (OTC) hearing aids is heating up again! There was a spike in interest last summer/fall with the Wall Street Journal article and petition to the Food and Drug Administration, and then things settled down again. Now I’m starting to see new activity on this issue.

Here with a dispassionate look at the topic is Dr. Mark Ross. We would be very interested in publishing responsible articles with additional points of view on this topic!

This article first appeared in the September/October 2004 issue of “Hearing Loss”; it is reprinted here with Dr. Ross’ kind permission.


Judging from the most recent edition of Audiology Today (May/June 2004), the issue of OTC hearing aids is still roiling the hearing aid industry, particularly the dispensing community. Its present incarnation began with a feature article in the March 24, 2004 issue of the Wall Street Journal. The article implicates the high cost of hearing aids as the most significant factor deterring people from obtaining hearing aids. The author then refers to two citizen petitions to the Food and Drug Administration: one to permit the sale of hearing aids over the counter and the other to eliminate the requirement that adults obtain a medical clearance before a hearing aid can be sold to them. (However, adults can now sign a waiver in lieu of the medical clearance. More about this later.)

The reasoning behind the petitions is the belief that the current cost of hearing aids (average about $2300) is effectively pricing many people out of the hearing aid market. The petitioners (Drs. Mead Killion and Gail Gudmundsen) believe that people with mild to moderate hearing losses can receive great benefit from a “one size fits most” type of hearing aid – one that is inexpensive and convenient to acquire. At the outset, it should be noted that neither of the petitioners believes, considering the services required for the professional fitting of a modern hearing aid, that hearing aids are currently overpriced. Rather, their stated intention is to broaden the hearing aid market to reach many people with hearing difficulties who are not currently receiving any help with personal amplification.

In this article, I’d like to review the pros and cons of this debate in as objective a fashion as I can. It’s an issue that should be addressed, not only for its implications for those presently unserved, but for the entire hearing aid industry, particularly those who make their living dispensing hearing aids. Although much of the debate has been framed in black and white, often emotional terms, the issue is much more nuanced, with the possibility of self-interest always lurking somewhere underneath the surface. As the article proceeds, I’ll also be discussing some of the associated concerns arising from the Wall Street Journal article and the two petitions.

It doesn’t take too much research to discover that top-of-the-line hearing aids are expensive. Nobody, not even the people who dispense them, would dispute that. For example, one woman I know was quoted a figure of $10,000 for two hearing aids, with FM boots and microphone/transmitter included. A figure of this magnitude, even minus the cost of the personal FM system (which I recommend), will produce palpitations in most people, particularly those who are retirees on fixed incomes. At the dispenser level, the rationale underlying this pricing structure is that it takes time to test someone, fit the person with a hearing aid, and to provide the required follow-ups. As, indeed, it does. Whether and how often this high cost deters people from purchasing hearing aids is another question, and, despite a number of marketing surveys, no good answer is available. Common sense and numerous anecdotal reports suggest that asking people to lay out four or five thousand dollars for two hearing aids is going to be a deterrent. This also applies to people who would like to replace a current set of hearing aids with more modern ones, but are postponing the decision because of cost.

We should recognize that people do not purchase hearing aids for many reasons other than their high cost. Some people may not even be fully aware that they have a significant hearing loss (although their family and associates will certainly know). Others deny the hearing loss entirely, or believe that their degree of communication difficulty does not warrant the “drastic” step of wearing hearing aids. Still others find the notion that they are somehow “deficient” simply unacceptable and refuse to advertise their “infirmity” by wearing a visible hearing device. Indeed, many of these people would not wear hearing aids even if they were free of charge.

It is difficult to estimate exactly how many people are deterred from purchasing hearing aids by their cost. The results one could obtain from a potential survey would vary according to respondents and phrasing of the question. To arrive at the most accurate estimate, one would have to query only those people who acknowledge their hearing loss and are favorably inclined to purchase hearing aids, but for whom price is the primary obstacle. Then the researcher would have to determine the point at which these people would decide that the hearing difficulty they experience warrants the cost of reducing its impact. Given sufficient difficulty, cost becomes a lesser factor (witness people who acquire cochlear implants).

The major rationale given for OTC hearing aids is that by reducing their cost and making their acquisition more convenient, we can increase the proportion of people who use hearing aids compared to those who need them. Right now, this figure is about 20% and it has hovered around there for many years. As it happens, we really don’t know how many people with hearing problems in this country (estimated to be between 20 and 28 million) can presumably benefit from amplification. All we know, by extrapolating from various studies, are the proportions of people who fail some predetermined hearing loss criteria, but we don’t know how many can be considered hearing aid candidates. However, we do have a better idea of the number of people wearing hearing aids compared to the total number of people in the U.S. Using this calculation, we find that a little more than 2% of our population now wear hearing aids. However, regardless of the figure given and how it is computed, it is clear that many people with hearing loss are not now wearing hearing aids, with some unknown number being discouraged by their expense.