Continuing last week’s post about UHC and Big Box stores going straight to retail for hearing healthcare, several topics must be focused on and dealt with soon. The first, which is the subject of today’s post, is the difference between a hearing aid and a personal sound amplifier product (PSAP). According to the FDA,
A hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing. A PSAP is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. While some of the technology and function of hearing aids and PSAs may be similar, the intended use of each article determines whether it is a device or an electronic product.
Big Box stores’ websites list hearing devices as PSAPs. When Googling “hearing aid,” results frequently include PSAPs available for purchase. One Big Box website describes its PSAP, in terms similar to those used to describe hearing aid function, which clouds the already-murky distinction between a hearing aid and a PSAP:
Speech enhancement and whistle block technology: Help define and amplify speech sounds for clear communication. Automatic noise detection automatically adjusts to changes in noise.
On the Best Buy store sites, PSAPs are listed with little or no mention of a hearing test or exam required. But Sams Club does have hearing aid to be sold direct with the sign of a waiver and no hearing test at all. The companies sidestep the FDA rules for hearing examinations by listing devices as PSAPs or “hearing devices.” On one such website that offers a “hearing test”– and I use this term loosely– the phrase “hearing aid” does not show up on any of their pages or descriptions, except in some testimonials. I will discuss this company more in my next blog.
The FDA site posted a clarification to the public in October 2009 explaining the differences between PSAPs and Hearing aids. This stemmed from Crystal Ear promoting their product to those with hearing loss, which was not in agreement with the FDA guidelines. If a hearing aid is sold, a hearing exam must be performed and a physician clearance must be obtained or a waiver (if over 18) must be signed.
The FDA’s distinction between two types of ear level devices enables manipulating language which allows these devices to be sold without meeting FDA requirements for hearing aids. I spoke with a VP of a major hearing aid manufacturing company, who recalled previous efforts within the FDA to tighten guidelines failed when they met political and industry resistance. Many of those resisters were members of the hearing aid industry. This VP was not one of them. Personally, I would venture to guess that major manufacturers may be leaning toward tighter regulations as a means of protecting the dollars they put into R&D to produce a high performance hearing aid. I am not a great fan of regulation as a whole, but I am following the pros and cons of more definition from the FDA. What do you think?