From: Chris_McCarthy/SouthWest/Sonus@sonus.com
Sent: Monday, October 27, 2003 6:07 PM
To: fdadockets@oc.fda.gov
Subject: Citizens petition file by Killion and Gudmundsen OTC hearing aids



I wanted to comment on OTC hearing aids and the current medical waiver changes proposed in a citizens petition filed by Meade Killion and his wife Gail Gudmundsen.  I have a problem with the term "entry level hearing aid".  First, a person either needs amplification or not.  They either need a hearing aid or not.  The only people making out on an OTC hearing aid is meade killion and etymotic research.  Crystal ear out of FL is an OTC hearing aid.  It's a piece of junk that most people throw money away on.  Most people would spend their money better on something else that they have no guidance or counseling on auditory nerves acclimating to new sounds or acoustic modifications made to a shell.  Please, please do not get rid of the medical waiver necessary for fitting hearing aids.  It is a necessary instrument in fitting hearing aids and controlling an industry that needs that control. I have been fitting the hard of hearing for years.  Many times I have to send a person to thier doctor because of a conductive component that the client may not be aware of.  Many times all aperson needs to do is clean their ears out.  OTC hearing aids keep these people who do not know their condition from having a check up and getting the necessary help they need.  Why should someone buy an OTC hearing aid when all they had was ear wax impacting the ear drum.  Meade made the $$ and the person was misled.  You as the FDA need to turn this petition flat down.  Do not let OTC hearing aids and doing away with the FDA medical waiver become a reality... 

J. Chris McCarthy
Board Certified Hearing Instrument Specialist
Sonus Hearing Healthcare
817-496-9272  Fax817-605-1047