By David H. Kirkwood
ARLINGTON, VA—A Consumer Electronics Association (CEA) report concludes that personal sound amplification products (PSAPs) “offer a viable solution to hearing aids for consumers who have hearing difficulty.” It continues, “While consumers who suffer from more severe hearing difficulties may still require hearing aids, PSAPs offer a simpler and often less expensive alternative for those with some or a little hearing difficulty.”
The report, a pre-publication copy of which was obtained by HearingHealthMatters.org, draws upon the findings of an online national survey of 3459 U.S. adults conducted by Rockbridge Associates for CEA in June 2014.
The CEA report comes at a time when the U.S. Food and Drug Administration (FDA), with strong support from hearing aid manufacturers and professional organizations in hearing care, is likely to approve a proposal to tighten existing rules prohibiting the marketing of PSAPs as a treatment for hearing loss. FDA’s position is that products designed for this purpose are hearing aids, and therefore are medical devices that must comply with FDA hearing aid regulations.
At the same time, more and more manufacturers are introducing such un-regulated products and marketing them, either explicitly or implicitly, as devices for people with hearing loss.
CEA, some of whose 2000 member companies make PSAPs, previously wrote to the FDA, opposing its plan to further restrict marketing of these devices. It stated that if the agency takes this action, “Millions of Americans who could benefit from affordable and readily accessible hearing solutions will remain unaware of the valuable assistance that PSAPs can provide.”
MAKING THE CASE FOR PSAPs
Using the data from its survey, the CEA report seeks to strengthen the case for permitting PSAPs to be sold as products to address mild to moderate hearing loss.
CEA reports that nearly half the adults surveyed said they had “some degree of hearing difficulties.” While most of them said they had only a little trouble, 11% have been diagnosed with hearing loss and 8% had not been diagnosed, but had some or a lot of trouble hearing.
The survey found that even among those with diagnosed hearing loss, only a third had hearing aids or cochlear implants. Most of those who reported hearing loss told the survey they had not sought help for it.
“The cost barrier”
In its report, CEA states, “Cost is a major barrier to consumers seeking help for their hearing difficulties and purchasing hearing aids but PSAPs may help overcome this.”
It continues, “The price for hearing aids… is higher than what most consumers, especially those with lesser degrees of hearing difficulties, are willing to spend for hearing health care and devices. PSAPs, which generally sell for about one-tenth of the price of hearing aids, could offer a gateway for consumers who may struggle with their hearing but don’t struggle enough to warrant spending $1000 or more on a hearing aid at this time.”
Strong demand seen
According to CEA, the survey found a strong demand for PSAPs among consumers with hearing difficulties. While only 10% of those with diagnosed hearing loss or who had a lot of trouble hearing currently own such devices, nearly 40% of them said they would be interested in buying an over-the-counter product to help them hear better. Of those expressing an interest in those products, 73% would be willing to buy it from a drug store, 55% from a “big box” store, and 48% online.
Current owners of PSAPs in the survey reported using them in fairly limited situations, most often for watching television, and only 10% said they use them on a daily basis. However, 41% of those who expressed interest in buying PSAPs envision using them daily and in multiple situations—more like the way people use hearing aids.
Response to medical concerns
In its report, CEA seeks to allay the concerns expressed by audiologists and hearing aid manufacturers that if people with hearing loss bypass the hearing professional and buy PSAPs, serious medical conditions underlying their hearing loss may go undetected with potentially dangerous results.
The association reports that its survey found that “the vast majority of those interested in using PSAPs are still likely to go to a medical or hearing health care professional for advice regarding their hearing difficulties.”
In fact, it conjectures, “Consumers may even be more likely to seek out medical advice knowing that these more affordable options for helping them hear better are available and enable them to hear better in the near-term.”
Author’s note: Attempts to reach CEA to find out the status of the report discussed above and to learn when and to whom the report would be distributed were not successful before my post was published.
Yet another shot across the bow…. traditional dispensing practices should be worried. Could de-regulation of hearing aids be that far off?
Bring it on. More than ever, consumers need a hearing enhancement coach to guide them to technologies that will meet their lifestyle needs. Sometimes the solution set will involved prescribed products; sometimes not. Marketing efforts should educate people that seeing an audiologist is a good place to start (or at least it woudl be a good idea to bring the already purchased PSAPs in for a check). Audiologists would do well to embrace non-traditional technologies and offer them to their patients. For example, if I see a patient who might need amplification and wants to try PSAPs, I would be open to it and would recommend probe mic testing to see verify how close the PSAPs are meeting target. I might also recommend PSAPs with telecoils if needed as well as other technology to meet the various daily listening needs of the patient. If the fit is verfied to be satisfactory and it makes a valid difference in functioning, then the patient buys the PSAPs. If not, then we move to hearing aids. This approach gets people help earlier rather than later and positions us as the “go to” professional.
This is a dangerous situation, as it flies in the face of the FDA rules. It specifically states that PSAPs and devices NOT meant to correct hearing loss, and yet the CEA states that they “offer a viable solution to hearing aids for consumers who have hearing difficulty.” How is that NOT in violation of the FDA guidelines?