In my former life, I was involved in Clinical Trials and Pilot Studies. Several of the Clilnical Trials were halted after the next morning when it was announced that a researcher put out statistics from Italy that the drug or device was proved helpful or hurtful to the patients all over the United States that this drug or device was either effective or not. It is unethical in medical practice to continue a Pilot Study or Clinical Trial at the same time as selling it to the market. UNETHICAL. We always halted the Clinical Trial or Pilot Study when the evidence showed that the device or drug were shown effective or ineffective. I will not share with you the drug or device because that is not part of the question. What is part of the question is that When I went to GW to get fitted with the Sonitus Sound Bite, I was given a form to sign saying that they would work one year on getting my health insurance company to pay $7000 device for one ear and after one year, they would start working out a nice arrangement with me to bill me the $7,000. That's when I pulled back my pen and called my insurance company and the nurse said NO NO NO don't proceed until everything has been pre approved.
Then besides my being part of a Pilot Study, I found out that Sonitus was holding Clinical Trials throughout the US for their device and at the same time asking me to be responsible for $7,000 should insurance not pay. I know my insurance will not pay. The Doc who happened to be Dr. Monfared formerly of Stanford and now of GW said that he does not do pre-authorizations. What was I to do. I always pre-authorize everything. I was doubly upset that Arasha who started this post said that she was getting the Sound Bite for Free because she was part of the original Clinincal Trial. So they are handing out free devices to people that post on this Forum and to people on the Clinical Trial but for people who live in places like Washington, DC, they are asked to sign a paper that they will pay $7000 if their insurance doesn't pay. So, the bottom line is that some people are getting this device for free and others are being charged $7000 for the same piece of Beta stage device. When I realized that, I stopped communicating with these people that do not follow portico;s of ethical medical professionals.
I will never go to Sonitus in spite of the fact that Cleveland Clinic has put them in the number one spot of all devices for 2010. They are just not following the ethical protocol that I was trained under and find the best way to go considering the people of the United States and beyond who are thinking of getting this Beta Stage device. I am telling you if you do not get this for free, then back down and wait until they have a better product that you are ready and willing to pay for. Don't bite now. They are not ready for market if they are still running Pilot Studies and Clinical Trials. Please believe me that I know what I am talking about.
I myself am going with Dr. S in Johnson City, Tenn because he was willing to get on the phone and explain to my insurance company how I needed the TransEar. He was the inventor of the TransEar and willing to get on the phone and encourage me to come down to Johnson City Tenn and also talk with United Healthcare about my hearing disorder due to the ACOUSTIC Neuroma. I cannot forget Dr. Schumacher's earnest interest in my situation. Sonitus did not do that for me because they are smack in the middle of Pilot Studies and Clinical Trials. Please believe me, they are not ready for the market. You all should be angry.
Sincerely,
Mei Mei
