by David M. Sykes, Vice Chair, The Quiet Coalition
Several Johns Hopkins researchers reported some research in the Journal of the American Medical Association that tested the notion that a cheap ($200-$400) unregulated “hearable” (also known as a personal sound amplification product or PSAP) may be a convenient and inexpensive alternative to a hearing aid.
The researchers tested a handful of the new hearable products just coming on the market and, sure enough, they perform as well as, or nearly as well as, expensive ($2000-$5000 per ear) hearing aids made by the “Big Six.” The Big Six are six companies that have controlled the hearing aid industry; their products are regulated in the U.S. by the Food and Drug Administration.
Recently legislation passed by Congress and signed into law just before the August recess, about which we have written earlier, requires the FDA to de-regulate, i.e. to take a hands-off approach to this new class of high-tech hearing devices. As a result, these new products can be sold over the counter, without a prescription.
Will you need to take them to an audiologist to get them fitted? Certainly you may choose to do so, and that may be the best option, particularly if you are concerned that improper use might endanger your hearing. But with a conventional hearing aid, patients were required to pay professional fees to an audiologist for fittings, etc., resulting in a bundled price that made the hearing aids unobtainable for many people who needed them. You can certainly expect to read articles claiming that these new devices pose a danger. Henceforth, it’s up to the consumer to decide—as he or she already does with regard to many other healthcare products, including over-the-counter drugs that formerly required a doctor’s prescription.
We say caveat emptor (buyer beware), but welcome these new products that cost 1/10th the price of conventional hearing aids. They are suitably priced to be able to meet the needs of 48 million Americans with noise-induced hearing loss, many of whom cannot afford the $4000 to $10,000 price tag for conventional hearing aids. Voters seem to want de-regulation—this is it!
In addition to serving as vice chair of the The Quiet Coalition, David Sykes chairs several professional organizations in acoustical science: The Acoustics Research Council, American National Standards Institute Committee S12, Workgroup 44, The Rothschild Foundation Task Force on Acoustics, and the FGI Acoustics Working Group—a partner of the American Hospital Association. He is the lead author of “Sound & Vibration 2.0 (2012, Springer-Verlag), a contributor to the National Academy of Engineering report “Technology for a Quieter America,” and to the US-GSA guidance “Sound Matters”, and co-founded the Laboratory for Advanced Research in Acoustics (LARA) at Rensselaer Polytechnic Institute. He recently retired from the board of directors of the American Tinnitus Association. A graduate of the University of California/Berkeley with graduate degrees from Cornell University, he is a frequent organizer of and speaker at professional conferences in the U.S., Europe, Asia, and the Middle East.