Over-the-Counter (OTC) Hearing Aids
- Part 2
by Mark Ross, Ph.D.
Previous
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.
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