From: Lee & Darrell Micken [lee@mickenhearing.com]
Sent: Wednesday, December 24, 2003 9:20 AM
To: Susan Stark Boyle
Subject: Re: comments on Gail and Mead's proposals

Thank you for responding to the Academy of Dispensing Audiologistsí request for submitting comments re: the Citizens Petitions for OTC hearing aids. In addition to sharing your viewpoint with the ADA board, we would also ask that you forward your comments directly to the FDA via e- mail to fdadockets@oc.fda.gov . Be sure to put the docket number in the "subject" line of your e-mail (2003P-0362 and 2003P-0363, for Killion and Gudmundsen, respectively). You will receive a message that your comment was received.

How to comment on proposed regulations and submit petitions

Specific guidelines for submitting comments may be found by going to the FDA website click on "Docket", then scroll down to "Inside FDA:How to Comment on Proposals and Submit Petitions"

How do I know if my E-comment was received?

When your comment(s) have been successfully submitted, you receive a confirmation message displaying your submittal on the screen. A comment number is displayed on the top portion of the screen above the comments section. An example of a comment number is: EC-1 . The Docket number and the Comment number (Example: 02Q-1234 EC-1) is your unique confirmation number.

Please contact Susan Flory, administrative audiologist, at s_flory@bellsouth.net should you have any questions or additional needs.

Again, we thank you for taking the time to construct and forward your comments to the ADA board regarding this important issue.

Sincerely,

The ADA Board of Directors

----- Original Message -----
From: Susan Stark Boyle
To: lee@mickenhearing.com
Sent: Thursday, December 18, 2003 12:29 AM
Subject: comments on Gail and Mead's proposals

I am unsure on how to react.......I don't believe that these recommended changes are ones that should be quickly decided upon. 
 
First, I must ask myself why Mead is so determined to sell hearing aids to any adult who wishes to purchase one over the counter....I can't help but think that this means lots of money for him---and is that the main reason for this stand!?   However, I did not read in his seven pages that he has something to gain----and he is suppose to disclose any and all negative and positive thinking as to his suggestion to the FDA. Also, is Mead even considering digital products, or only analog?
 
Second, since some amplifying products are already being sold directly (as mentioned in his letter) to patients and no government agency is able to stop them---why is this area being discussed????
 
Mead states that with the visually impaired chosen "appropriate magnification, no one is prevented from 'reading clearly' ."  I remember how easy it was to tell the eye doctor which lense was clearer, and then I was able to see clearly with the same glasses during day light, night time and dusk, etc.  However, I was not able to have peripheral vision...just was able to see straight ahead.  Luckily, I was able to turn my eyes towards what I wanted to see so I was able to get around this peripheral problem.  Also, I was again able to control my environment by turning on the light switch to enhance my vision as needed.  I have never thought of comparing vision to hearing----and am somewhat surprised that anyone in our profession would think that a comparison in addressing a disability in these two senses could be fairly accomplished. The hearing organ is so complicated and patient's lifestyle and perceptions further complicate it.   
 
Why can't patients purchase false teeth in the drug store?  Are they really buying a product or are they buying the expertise? 
 
Too many hearing impaired people refuse to consider a professional hearing aid fitting because they have already been "burned" by salespeople who took their money!  When asked why they didn't return the hearing aids during the trial---the answer is too often that they were embarrassed that they made a mistake in going to the wrong place or they thought that what they had must be the best because that's what the advertisement stated (and the picture showed the "specialists"---salespeople dressed in white lab coats----just like doctors!  So being taken advantage of and the confusion of the sales arena are what people in my city tell me are the reasons they haven't addressed the hearing loss issue.  Until one is exposed to truly custom hearing aid fittings,----one could/would never know what is possible!!!!
 
I imagine that the next thought will be to let the patient decide which pacemaker he wants to purchase and let him wire it up himself.
 
I do, however, agree that the medical clearance is antiquated and should be eliminated.  To have an ENT "provide medical clearance" is interesting since I have not met an ENT who would sign off on this clearance until his/her audiologist performed an audiologic evaluation and provided him/her with the findings first. How funny has this always been!!
 
Let us not step backwards---but continue forward.  For successful exceptional long-term hearing aid fitting results---consider professional fittings by audiologists.
 
Susan Boyle
918 495-1650