Over-the-Counter (OTC) Hearing Aids

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.

The intention of the petitioners was to introduce a line of OTC hearing aids to sell for somewhere between $100 and $300. This would not be a toy or a cheap piece of junk. From what I understand, it would include an advanced compression circuit (the K-Amp), with an undistorted output of about 108 dB SPL with a frequency range extending from 200 to 10,000 Hz. It is designed to be a “one size fits most” type of hearing aid, specifically (as stated above) for people with mild to moderate hearing losses. It would be, I’m confident, a high-performance hearing aid.

The question now is, will the provision of a low-cost, easy to acquire hearing aid actually produce an increase in the number of people wearing hearing aids? Nobody can answer that now, but it does seem a likely inference to make. We can shed further light on this question by determining the proportion of people using hearing aids in some European countries in which the cost of a hearing aid is covered in all or part by National Health Services. These figures vary from country to country, with some (such as the United Kingdom and Denmark) reporting relatively high percentages, while others (Sweden, Norway, and Finland) report somewhat lower percentages. In a reasonable interpretation of the estimates I received, an average of about 3% of the population in these countries wear hearing aids, compared to a figure in our country of 2%. While this difference may not sound like much, it would translate into approximately 1.5 million more people wearing hearing aids here. If we assume fairly similar cultural attitudes toward hearing loss and hearing aids in these cited European countries, then it does appear that cost considerations do deter many people from wearing hearing aids in the U.S.

If higher costs were unambiguously related to greater hearing aid satisfaction by consumers, then the high price of hearing aids could more easily be justified. An article by Sergei Kochkin (the “guru” of hearing aid demographics) in the February 2003 issue of The Hearing Review bears directly on this question. In this article, Kochkin reviews a number of factors associated with customer satisfaction. Many, such as reliability, sound quality, and hearing in background noise were highly related to satisfaction with hearing aids. This is not surprising. Insofar as price is concerned, however, he points out that he has (in numerous studies) found no practical correlation between overall satisfaction and the cost of hearing aids. On further analysis, however, the situation does get a bit more complicated.

Kochkin distinguishes between a person’s satisfaction with the perceived benefit derived from a hearing aid (how much it actually helps improve hearing) and the satisfaction felt with the perception of the value of the aid relative to the price paid. In other words, it is perfectly possible for people to feel that a hearing aid benefits them, but to question whether the benefit they obtain is worth the price they paid. In terms of benefit, there is a slight positive correlation with price: the more a person pays, the greater the apparent benefit. However, as was pointed out in the article, this is a very weak correlation. In terms of perceived value, the relationship between satisfaction and price is slightly downward: i.e., the more people pay, the less likely they are to be satisfied with the value of the hearing aid.

This result seems perfectly understandable. With higher prices, one is able to include features not available in lower-cost hearing aids, such as directional microphones. Thus the greater benefit. For example, a number of studies have demonstrated that people are able to derive additional benefit from hearing aids that incorporate directional microphones. It has also been found that satisfaction is greater with this type of aid than with aids that lack this feature. Other features may be particularly important for a specific person, consequently increasing the benefit and perceived value of the hearing aid for this person. When people pay a great deal of money for their hearing aids, then they rightfully expect a great deal more benefit from them. According to Kochkin, however, only about half the people surveyed are satisfied with how their hearing aids function considering the price paid for them.

Does this mean that OTC hearing aids, considering their relatively low cost, will provide sufficient aided benefit to those with mild to moderate hearing losses to justify their purchase? For many people, undoubtedly. After all, many of these people can get noticeable hearing help simply by turning the volume up on the TV or stereo. (Of course, this may mean that their family will have to leave the room!) A simple amplifier that just increases the audibility of the sound signal will provide some help to people with this degree of hearing loss. I have two mail order catalogues in front of me that advertise hearing aids (labeled as “sound amplifiers” rather than “hearing aids”): one costs $19.99 for a body unit while the price of the other one is $39.99 for an in-the-ear model. I’ve seen these ads for years and they must be selling these devices to somebody. Undoubtedly, some people who purchase them probably feel that they are helping reduce their hearing difficulties. (Please note that these mail order devices are a far cry from responsible Internet sources that can provide top-of-the-line hearing aids at a substantially reduced cost, including some sort of professional consultation.)

There are, of course, pitfalls and problems with OTC hearing aids that must also be addressed. These will be reviewed as they occur to me and not necessarily in the order of importance (which, in any event, would be difficult to determine).

OTC hearing aids would require the elimination of a medical clearance (only for adults) before a hearing aid could be purchased. Indeed this was the major reason given by the FDA for its rejection of the two petitions, the reasoning being that such medical clearances are necessary for the well-being of the patient. Instead, the petitions suggest that the written material provided with the OTC hearing aid would include information on how to recognize “red-flag” conditions that require the intervention of a physician. These include a sudden or rapidly progressive bilateral or unilateral hearing loss, drainage from the ear, soreness or redness in the ear, and cerumen impaction. We have no idea how convincing or effective this information would be for people contemplating the purchase of OTC hearing aids. Certainly, one would hope that anybody experiencing a “red-flag” condition would be seeing a physician before considering purchase of any kind of hearing aid. The problem is that people can’t see inside their own ear canals.

As it happens, we don’t know how effective the current prior medical clearance requirement is now. Under the present system, adults can sign an informed request form that enables them to waive the medical clearance. I have been unable to uncover any large-scale surveys that compared the percentage of hearing aid users who received a medical clearance to those who signed the waiver. In many hearing aid dispensing offices, clients are routinely asked to sign the waiver. Others make it a practice never to fit a hearing aid on any client unless a medical clearance has been obtained, usually within the past six months. One major advantage of seeing an audiologist is that part of the prior audiological evaluation includes taking a hearing history and examining the ear canal. So whether a medical clearance is obtained or not, red-flag conditions should still be apparent to the examining audiologist.

One study, reported in the 2003 issue of The Journal of the American Medical Association, reports that up to 30% of elderly people may suffer from impacted wax and chronic otitis media. This is the kind of condition that would be visible during a personal visit to an audiologist but would be missed if a person self-purchased hearing aids over the counter. Since the removal of cerumen is within the scope of practice of audiologists (although some states do not permit it), this is a service that can be provided right in the dispenser’s office.

OTC hearing aids are designed for people with mild to moderate hearing losses. For people with this degree of hearing loss whose audiometric configuration is flat or gradually sloping, I have no doubt but that a good quality OTC hearing aid could provide significant hearing benefit. The problem is that many people do not know the threshold configuration of their hearing loss unless they’ve had a recent audiometric evaluation. They may think they have a mild to moderate hearing loss indeed, on the average, they may well have but the hearing thresholds could be taking a sharp drop at 1000 Hz or 1500 Hz without them being fully aware of this. There’s simply no way that a “one size fits all” hearing aid would provide an appropriate pattern of amplification to such people.

I suspect that many, if not most, people purchasing OTC hearing aids would opt for one rather than two. However, binaural amplification usually offers listening advantages that do not occur with monaural hearing aids. And not only this, but we know that long-term monaural amplification may result in adult-onset auditory sensory deprivation, which, while not affecting thresholds, can reduce the speech perception capacity of the unamplified ear. Without professional advice regarding the advantages of binaural amplification, it is unlikely that many people would purchase a binaural set of OTC hearing aids unless, of course, OTC aids were sold in pairs in the same way reading glasses are sold (anybody ever see a “reading monocle?).

There is the danger that a bad experience with OTC hearing aids may discourage some purchasers from seeking professional assistance with professionally fit hearing aids. We already know that this occurs. Some people who have a bad experience with hearing aids not only swear off hearing aids for themselves, but discourage other people from trying them. Of course, the reverse may also be true: a good experience with OTC hearing aids may convince some other people to pursue more sophisticated assistance for their hearing problems. At this point, it is fruitless to speculate which of these possibilities is more likely. Both are possible and both would likely occur.

We do know that OTC hearing aids will not include many of the advanced features now incorporated in top-of-the-line hearing aids. Additionally, right now there does not appear to be any plan to include telecoils in these hearing aids. Of course, not including these features is one reason why they could be sold for a relatively modest sum. Presumably, people with mild to moderate hearing losses will have less (or no) need of many of the special features found in current hearing aids (such as feedback management and wide-dynamic range compression). But even people with moderate hearing losses could hear better in noise with directional microphones, a feature that would probably not be included in OTC hearing aids.

With OTC hearing aids there would not be any personal involvement by any professional. Frankly, this worries me. It’s not that I think that professional hearing aid dispensers “prescribe” a unique set of performance characteristics for each of their clients that only a professional can accomplish. (I have no doubt, however, that most sincerely believe they do.) Hearing aid prescriptions (or targets) are not that finely drawn. There are a number of them out there, each somewhat different from others, and none of them are set in concrete. All of them often partake of a post-fitting trial and error process; none have consistently demonstrated a clear-cut superiority over the others, but all seem to help most of the people fit with them. Indeed, I would be willing to bet that if a number of audiologists were asked to fit a trial subject with hearing aids from different companies, the range of the final performance characteristics of the hearing aids would vary greatly. None would necessarily be “wrong,” since human beings are usually very tolerant of and can adjust to minor differences in the performance characteristics of their hearing aids. No, it’s not the actual fitting process that worries me.

What does concern me is the rest of the hearing aid selection process. Hearing aid users need to have an understanding professional to whom they can relate their hearing problems. We know that, regardless of the type of hearing aid, a person’s hearing aid satisfaction increases with the number of hours devoted to counseling. This can take the form of information sharing about hearing loss and other types of devices, hearing tactics and repair strategies, resolving problems with the hearing aids, etc. Just because someone has a mild to moderate hearing loss does not mean that he or she cannot also benefit from this type of information. Personal perception of one’s communication problems may well be greater than the audiogram would suggest.

Of course this statement has a corollary, and that is the need for hearing aid dispensers to actually provide the kind of information and counseling that people require. This is, indeed, one of the major rationales given by hearing aid dispensers for the high cost of hearing aids, that they do provide the range of personal services that people with hearing loss require. The reality today, however, is that hearing aid dispensers spend the overwhelming majority of their time on issues relating directly to the fitting process (testing, earmolds, etc.) and little on what could be called the “rehabilitative process.” In a study reported in this journal in May/June 2002, we reported on the services that 942 people recall receiving from their hearing aid dispenser. Half the people did not recall receiving information about telecoils, and only 31% received information about other hearing assistive technologies. Only 20% reported that their hearing aid dispenser discussed the specifics of the hearing loss with them and with a family member. Even fewer reported receiving information about communication or coping strategies. Finally, only about 5% of hearing aid dispensers offered their clients an opportunity to participate in a group hearing aid orientation program (as recommended by one of the SHHH position papers).

So what can we conclude from this discussion? As noted above, this is not a black and white issue; the color gray may be a more realistic descriptor. I think the basic rationale presented by the petitioners is indisputable: hearing aids are expensive, and this does deter some unknown number of people from purchasing their first or replacement aids. Many of these people can undoubtedly be helped with OTC hearing aids. Furthermore, if someone was one of the “ideal” candidates no cerumen in the ear canal and a relatively flat audiogram I suspect that he or she could achieve as much measurable benefit from an OTC aid as from a more costly, personally fit hearing aid. (One exception I would make is aids that contain effective directional microphones.) I can also see where experienced hearing aid users who have some basis to compare their performance with previous hearing aids, may find an OTC aid worth a try. This is not a trivial number, since they comprise some 57% of new hearing aid sales. But for new users, who may have little idea of the configuration and nature of their hearing loss, particularly those who have needs that transcend what a simple amplifier can do, an OTC is probably not a good idea.

Perhaps this debate will help serve as a wake-up call to the dispensing community. The provision of services beyond the actual hearing aid fitting is what justifies the high prices paid for hearing aids. A hard-of-hearing person sees an audiologist not so much to purchase a hearing aid, but for help with his or her hearing problems. These may require services that extend beyond the help that hearing aids can provide. To the extent that hearing aid dispensers restrict their focus to hearing aids, they are easily replaceable by OTC hearing aids, internet outlets, and automatic computer fitting of some sort (plug the audiogram in and out comes a hearing aid incorporating some recommended “prescription”). However, understanding and responding to the many life-inhibiting consequences of a hearing loss is something that can only be done by a human being. The challenge facing the hearing industry is how to accomplish this, and still provide lower cost alternatives to the many people presently unserved who require hearing aids but cannot afford them.