Utilization of PSAPs and Direct-Mail Hearing Aids by People with Hearing Impairment

The effect of direct-mail and PSAP devices on the custom hearing aid market

Within the last 2 years, we have seen an increased proliferation of one-size-fits-all hearing aids and personal sound amplifier products (PSAPs) advertised on television and by direct mail. They can be purchased over the Internet and through the mail, as well as from eBay, Amazon.com, most pharmacies, hardware stores, Radio Shack, and Sears. In Google searches, many of these products come up on the first couple of search pages when you search
on “hearing aids” and are sponsored links under the search term “hearing loss.”
Most of these products clearly state that they are not intended to compensate  for hearing loss; but it is clear from their advertising that they target people with hearing loss with such claims as:
■ Never miss another word at lectures, movies, shows, or even church;
■ Turn up the volume on what people around you are saying;
■ Listen at the level you want withoutdisturbing others;
■ Hear a pin drop from across the room;
■ Turns ordinary hearing into extraordinary hearing;
■ Has the ability to give you sonic hearing, easily amplifying sounds up to 90 feet away;
■ Flexible ear mount easily adjusts to fit all ear shapes and sizes; and
■ The convenient volume control lets you easily control the intensity and volume.
The FDA has recently issued a guide that differentiates between the intended uses of hearing aids and PSAPs. To quote from the FDA Guide1 :
While these personal sound amplifiers may help people hear things that are at low volume or at a distance, the Food and Drug Administration (FDA) wants to ensure that consumers don’t mistake them—or use them as substitutes—for approved hearing aids.
“Hearing aids and personal sound amplification products (PSAPS) can both improve our ability to hear sound,” says Eric Mann, MD, PhD, deputy director of FDA’s Division  of Ophthalmic, Neurological, And Ear, Nose, and Throat Devices. “They are both wearable, and some of their technology and function is similar.”
Mann notes, however, that the products are different in that only hearing aids are intended to compensate for impaired hearing. He says consumers should buy a personal sound amplifier only after ruling out hearing loss as a reason for getting one.
“If you suspect hearing loss, get your hearing evaluated by a health care professional,” he adds.
Choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing, says Mann. “It can cause a delay in diagnosis of a potentially treatable condition. And that delay can allow the condition to get worse and lead to other complications,” he says.
Some direct-mail firms sell one-sizefits-all hearing aids targeting people with hearing loss, but get around FDA regulations with such statements as:
■ They are not meant to supplant hearing aids since they are not “hearing aids”;
■ They are personal sound amplification systems (PSAPs);
■ They are like reading glasses for the ears;
■ They are hearing helpers;
■ We are committed to the unserved hearing-impaired consumer;
■ Obtaining hearing help doesn’t have to cost $1000s!

Demographic characteristics of owners of custom hearing aids

Demographic characteristics of owners of custom hearing aids

Other direct-mail firms clearly state they are selling hearing aids by direct mail, but ask the consumer for a medical waiver before they send them hearing aids from  their catalog as a means of meeting FDA requirements. In addition, some provide counseling either by phone or online to help the consumer choose the right hearing aid for their hearing loss.
This is the fourth in a series of publications from the Better Hearing Institute’s MarkeTrak VIII (2008-2009) database on the hearing loss population. In this publication, we will:
1) Estimate the size of the current population of people with hearing loss who use direct-mail hearing aids or personal sound amplifier products (PSAPs) to compensate for their hearing loss;
2) Compare the hearing loss characteristics and demography of the users of one-size-fits-all products to those
of the custom hearing aid user; and

3) Estimate the population of people with hearing loss in need of customizable amplification who are using
PSAPs as a substitute for custom hearing aids.

A detailed description of the methodology for the MarkeTrak VIII survey is documented in the first publication,2
which appears in the October 2009 HR (available at www.hearingreview.com), so it will only be summarized here.
In December 2008, a short screening survey to 80,000 households was completed by 46,843 households, identifying 14,623 people with hearing loss and providing detailed demographics on  those individuals and their households.
The response rate to the screening survey was 59%. In January 2009, an extensive 7-page survey was sent to the total universe of hearing aid owners (n=3,789) in the panel database; 3,174 completed surveys were returned, representing an 84% response rate. In February 2009, an extensive 7-page survey was sent to a random sample of 5,500 people with hearing loss who had not yet adopted hearing aids. The response rate for the non-adopter survey
was 79% (n=4,339).

Direct-mail hearing aid and PSAP user population size. In querying our MarkeTrak database of hearing aid owners
during January 2009, 3.28% (representing about 280,000 people in the United States) indicated they received their hearing aids by direct mail; in comparison, 3.68% (or 270,000) were direct-mail hearing aid owners in the MarkeTrak VII (2004) survey. For further analysis due to small sample sizes, the direct-mail respondents from MarkeTrak VII and VIII were combined, yielding a sample size of 187 people.
In the non-adopter survey, we asked respondents if they purchased PSAPs costing less than $50 for their hearing loss. To make sure they understood what we were referring to, we specifically listed the most popular devices by brand name, especially those advertising on TV. In addition, we assessed the likelihood that they purchased
the device in place of a custom hearing aid; this was accomplished by the person with a hearing loss indicating what they would have done in the absence of PSAPs in the marketplace. Subjects responded to a 5-point scale ranging from 0%-100% likelihood that they would have purchased a hearing aid if PSAPs were not available in
the market. PSAP owners were found to be 4.79% of the non-adopter population, representing 1,237,700 people.
The PSAP sample size for further analysis is 208 people.

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