For all of you out there that are wanting to know how the FDA classifies products sold for hearing loss. As you can see, there is more emphasis on the labeling of these products vs. the actual regulation of them. This would explain why you see commercials on television for the devices that are selling for the most part under $100. THEY AREN'T VERY GOOD! There is no requirement for testing or product evaluation per the FDA.
Hearing aids aren't much better in the regulation department unless you are dealing with children. Once the FDA 'classifies' a product, this leads to how the insurance industry can get out of paying for it. After reading this document, I am very surprised at the lack of insight, regulation and testing for something that is needed and used by so many people. There are many gray areas where the seller can get by with what descriptions and language are used in order to get their product on the market and avoid having to go through the government safeguards (Where are they?) in order to sell a product that will supposedly improve your hearing.
http://www.fda.gov/cdrh/ode/guidance/1696.pdf
Add in the fact that back in 2004 a group of citizens sent a petition to the FDA to get them to eliminate the requirement that you have to have a audiological evaluation/medical consultation in order to get access to hearing aids. What do you think happened to that request? Well, the American Academy of Audiologists (9,000 strong at that point) sent the FDA a rebuttal saying that the cost of hearing aids was definitely not a factor for those of us in HOH world! They didn't want to lose the control given to them by the FDA regulations that all of us be seen, assessed, ect. by them vs. buying a product that we wanted and had researched. Here's the link to their letter to the FDA. It took a few years, but finally the FDA agreed that we could 'sign' a release form that would let us turn down this expensive and for the most part unnecessary requirement. After all, once we find out what our loss is, we really don't need to keep going back to the Doctors for them to tell us the same thing. We do need to get an audiological evaluation/hearing test before getting new aids, but paying the cost for an ENT every 3-5 years when you have already had it confirmed that your hearing loss is not caused by any disease is kind of ridiculous.
http://dev.aaa.susqtech.com/NR/rdonlyres/9A01DEEF-96F5-4F59-A0C3-2830BB197F89/0/20040127.pdf
But, lo and behold! If you are eating cheerios to reduce your cholesterol, the FDA is busy taking care of that one! Get ready for the price of Cheerios to go up after the company is forced to redo the labeling on the boxes...
http://wcbstv.com/health/cheerios.general.mills.2.1007986.html
Another great use of our taxpayer dollars....
Have a great week!
Copyright 2009 Tami Klink