Why do we get the good stuff last?  Why does it sometimes take years longer to get a product approved for sale in the United States than in Europe?  The answers to these and other questions about product development lie in the fact that there are some major differences in the American and the European product development systems. Both insure public safety for food, drugs, cosmetics, medical devices and other products, but they go about the process differently.

Like it or not, the FDA is the agency that controls many product offerings to Americans as well as to citizens of the many other countries that will not allow the sale of certain foods, drugs or medical devices (such as hearing instruments, testing equipment, implantable hearing devices) unless they have been approved for sale in the United States.

In Europe and in other countries that follow the CE marking system, of course, there is a whole different process to insure that food, drugs, cosmetics, medical devices, and other products are safe and ready for the marketplace. It is well known in the hearing industry that companies manufacturing new and innovative products go to great lengths to obtain CE marking for their devices so that these products can go into production and sale in Europe and other countries that accept CE marking first and later on work their way through the FDA approval process. This allows manufacturers to sell their products in Europe, thus generating income to stay in business while they work their way through the grueling task of obtaining permission to sell their product in the United States and countries that adhere to  the FDA development system.

What ARE the differences in these systems? Does the FDA process lead to a safer product? Is it overkill? Would we be better off with a European-style system? To answer these questions we must review the systems and conduct a sort of compare and constrast exercise.

Who is the FDA?

By its own definition (FDA, 2011), The Food and Drug Administration is an agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation, and by regulating the manufacture, marketing, and distribution of tobacco products.

The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods, and to reduce tobacco use to improve health.

Although certain medications and foods are important to all of us, for our purposes at Hearing International and as audiologists we are most interested in medical devices area.

What is a CE Mark?

CE marking is a symbol that is the abbreviation of the French phrase “Conformité Européenne,” or, in English, “European Conformity.” The initial term for it was  the “EC Mark.” This was officially replaced by 1993 European legislation that now designates ”CE Marking” as the standard. “CE Marking” is defined as a written statement and is a declaration prepared by the manufacturer to demonstrate the fulfilment of the EU requirements relating to a particular product that will bear the CE mark.  According to CE Mark (2011), this declaration documentation must cover one or more products manufactured and be clearly identified by means of product name, product code or other unambiguous reference.  These records must be kept by the manufacturer, or his European Authorized Representative if the manufacturer is based outside the European Union.  CE Marking is recognized by many countries as the standard for safety and benefit of medical devices.

Next week we will look at how these agencies scrutinize and evaluate medical devices

References:

Food and Drug Administration Website (2011).http://www.fda.gov/AboutFDA/CentersOffices/default.htm

CE Mark (2011). How do I get CE Mark and what does it mean. CE Marking.org: Retrieved from the World Wide Web August 27, 2011: http://www.ce-marking.com/what-is-CE-marking.html

Emergo Group (2011). Sections and format of a 510(k) proposal. Retrieved from the World Wide Web August 30, 2011: http://www.fda510k.com/510k-sections-and-format

Really, this is what it is all about. People who have hearing loss don’t really want to wear a hearing aid (SHOCK!). Who would? This might seem like blasphemy to my fellow audiologists, but don’t you think it’s the truth?

What they REALLY want is to hear better. They want to hear their friends, family, and co-workers. They want to hear conversation so that they don’t respond embarrassingly to what someone says. Every miss a punchline? They want to hear music again the way it was meant to be heard. They want to know when a bird is flying overhead–and duck when necessary!

The hearing aid is simply the tool by which they can achieve this goal.

I have seen a lot of patients over the two decades I’ve worked in this industry, and it is rare that someone has told me that they actually regret getting hearing aids. Sure, these little devices have their problems, but that’s simply a matter of getting the appropriate follow-up work, whether it be maintenance, fine-tuning of sound quality, or just instructions on how best to get the most from the instruments. And, therefore, how to hear better.

So, the point of this BLOG is to share my thoughts on the industry, patient needs, and technological developments as they come up. I had this created nearly a year ago, but just now got myself to actually do something with it. So be patient with me; it’s a learning process, as usual.

Sincerely,

Scot Frink, Owner, Salem Audiology Clinic

Are you are one of those millions of people who do not hear as well as they once did? If so, you are certainly not alone. Consider these statistics reported by Sergei Kochkin, Ph.D., Executive Director of the Better Hearing Institute :

* 3 in 10 people over age 60 have hearing loss;
* 1 in 6 baby boomers (ages 41-59), or 14.6%, have a hearing problem;
* 1 in 14 Generation Xers (ages 29-40), or 7.4%, already have hearing loss;
* At least 1.4 million children (18 or younger) have hearing problems;
* It is estimated that 3 in 1,000 infants are born with serious to profound hearing loss.

In addition, studies have linked untreated hearing loss to emotional, physical, mental, psychological and even economic disadvantages! And, to make matters even worse, there are many “myths” about hearing loss that prevent those with hearing loss from doing anything about it.
Causes of Hearing Loss

One of the most common “myths” about hearing loss is that only “old people” suffer from it! In fact, the reverse is true! The majority (65%) of people with hearing loss are younger than 65 and six million people in the U.S. between 18 and 44 suffer from hearing loss (Better Hearing Institute website).

The truth is that there are several causes of hearing loss with “exposure to noise” ranking high among the reasons. The primary causes of hearing loss are:

* Exposure to noise
* Medicine
* Aging process
* Disease
* Head trauma

Types of Hearing Loss

Not all hearing loss is corrected through the use of hearing aids or alternative listening devices. Type of hearing loss determines the specific treatment required.

There are four types of hearing loss:

* Conductive: This could be caused by something as simple as earwax buildup!
* Sensorineural: This is caused when tiny hairs in the cochlea are missing or damaged.
* Mixed: This is a combination of conductive and sensorineural hearing loss
* Central: Strokes and central nerve diseases are often the cause of this type of hearing loss.