From: Jvdmike@aol.com Sent: Monday, December 01, 2003 6:39 PM To: fdadockets@oc.fda.gov Subject: Docket # 2003P-0362/CP 1 In reference to docket number 2003P-0362/CP 1 To whom it may concern, JVD INC. manufactures the "K Amp" circuit used in many hearing aids by customers of Etymotic Research. If hearing aids were dispersed similarly to eyeglasses, hearing aids would be produced at much larger volumes, creating higher performance and a lower price. At present the major cost of a hearing aid is determined by the distribution system, not the manufacturing cost. If hearing aid distribution had the equivalent of the "reading glasses" stage, this would create a relatively high volume, low cost product. Over the counter hearing aids would be the equivalent. As the customer's hearing problem progresses, he would then contact an audiologist, just as he would an optomitrist as he progressed beyond the reading glasses stage. He would be accustomed to the advantages and shortfalls of hearing aids so far fewer $2,000 hearing aids would be relegated to the dresser drawer. Sincerely, Jerry VanDierendonck President JVD INC.