Request that the ("Commissioner") investigate actions taken by the Center for Devices and Radiological Health ("CDRH") related to the August 8, 2011 proposed rule
cdrh cranial electrotherapy stimolator August 8, 2011 76 FR 48062 CES February 10, 2012 insomnia chronic pain open
2013-04-22 2013-04-22 2013-04-22 2013-04-22 2012-04-19 2013-05-20 2013-04-22 2013-04-22 2013-04-22 2013-04-22
FDA-2012-P-0260-0014 FDA-2012-P-0260-0015 FDA-2012-P-0260-0012 FDA-2012-P-0260-0011 FDA-2012-P-0260-0004 FDA-2012-P-0260-0019 FDA-2012-P-0260-0010 FDA-2012-P-0260-0013 FDA-2012-P-0260-0007 FDA-2012-P-0260-0008
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https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0014 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0015 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0012 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0011 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0004 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0019 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0010 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0013 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0007 https://api.regulations.gov/v4/comments/FDA-2012-P-0260-0008
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As a PhD psychotherapist who supervised clinicians in a WTC mental health program for five years, I experienced a severe case of PTSD after leaving the program, with accompanying depression.  That lasted for almost two years.  When the Fisher Wallace stimulator was recommended to me, I had never heard of it, but obtained the device within a week.  Using it for 20 minutes per day on the lowest level level I had no side effects from it, and my symptoms were almost totally alleviated within 10 days.  For myself, I need to use the machine at least three days per week to remain symptom free.  The machine is not expensive, I can use it while drinking my morning coffee and reading the paper, and it has been easier than playing around with psychotropic medications to try to find one that would work, and it has nine of the side effects of meds!!! The Fisher Wallace device is excellent. I have recieved much praise from my patients who have used for pain, anxiety and depression. I highly recommend it. I am a board certified psychiatrist in practice for 34 years.  I have founded several mutispecialty centers and maintain a private practice.  I served as Assistant Clinical Professor of Psychiatry at UCLA from 1979--2001.  I am author of Contagious Emotions:  Staying Well When Your Loved One is Depressed, a Simon and Schuster hardcover and trade paperback.I have direct clinical experience using the FW Cranial Stimulator on patients with insomnia, GAD, Major Depressive Disorder and Bipolar Disorder, Depressed.  I have prescribed the FW device to approximately 30 patients.  The device has been well tolerated by every patient and not one patient has ever returned their device within the 60 days period that is given for refunds.  I most commonly use the device in combination with other therapies but have used it as a stand alone device for insomnia.The device should be classified no higher than Class Two.  It has less adverse events than patients I have sent for rTMS therapy--in fact every patient has complained about some adverse effects from TMS.  Its efficacy has been greater and it is a far less invasive treatment in terms of delivery.  I have no financial interest in the Fisherwallace company nor do I receive remuneration from the company.  I am voluntarily contributing this information to correct a mistake that does a disservice to patients.   I have used a version of the Fischer Wallace Stimulator on both myself and patients for more then 20 years.  More recently I have specifically used the Fischer Wallace Stimulator, also on patients as well as myself.  Indications I have used it for include pain and menopausal symptoms including fatigue due to poor sleep at night.  I have NEVER had a serious side effect from the unit. Once in a while a patient may complain of feeling slightly dizzy after using the unit but nothing else.  It works well on orthopedic type pain such as low back or cervical pain.  It works great for calming headaches.  I strongly endorse the use of this unit. Bonnie OConnell, Physical Therapist Cranial electrostimulation (CES) is a safe, effective, economic treatment for the symptoms of anxiety, depression, and sleep disturbance that commonly occur in soldiers and veterans suffering with posttraumatic stress. The device and therapy offer another option in addition to psychotropic medications and verbal therapy for the treatment of these conditions. In the past 10 years, over 2.5 million men and women have served in the combat theaters of Iraq and Afghanistan. Estimates of those suffering with posttraumatic stress range from 20 to 40%, or 500,000 to 1,000,000. CES devices offer significant, clinically meaningful advantages over existing approved alternative treatments, especially over those anti-depressant medications that are ineffective in treating soldiers with PTSD. Cranial Electrotherapy Stimulation devices, including the Fisher Wallace Stimulator, are intended to treat life-threatening or irreversibly debilitating psychiatric conditions in soldiers suffering from depression, anxiety and insomnia in association with Post Traumatic Stress and substance abuse.The availability of the device is in the best interest of patients  especially our soldiers.  With the return of hundreds of thousands of soldiers from Iraq and Afghanistan, subjecting CES manufacturers to the PMA process will interfere with the availability of these devices precisely when access to them is most needed.   Because I have chronic pain and most nights cannot sleep through the night, I decided to try the CES unit to see if it would help me sleep and might relieve some of my fibromyalgia and arthritis pain. I was amazed at the first nights relief. By the end of the week I was sleeping without break for the entire night.  I was  in absolute disbelief. Awaking pain-free with the ability to move and walk was truly wonderful. I have recommended the CES unit to my military clients and I am appalled that this valuable noninvasive technology is in peril of not being available. The Fisher-Wallace device has been extremely effective with many patients with whom I have used it to improve depression, anxiety, and sleep issues.  I am finding it more effective than other similar devices. I am a mind/body psychotherapist and dance/movement therapist, in private practice and teaching here and in Europe, in and out of academic settings.I have had several severe repetitive impact injuries resulting from working with seriously psychotic patients with dance/movement therapy in hospital and clinic settings for over 30 years. I have had 3 major surgeries as a result of these injuries: one for a large calcified  tumor in my right metatarsil, a 3 level lamenectomy and micro-discectomy on my lumbar spine, and a shoulder surgery with 12 elements, including repairing a full rotator cuff tear, and repositioning my biceps tendon.Because I also have severe cervical stenosis, as well as lumbar stenosis,  and have been having severe radiculating pain down my right arm, I was told I likely would need neck surgery in the future to address this problem.The pain made it difficult for me to sleep and lack of sleep made the pain worse. My osteopath suggested the Fisher Wallace Stimulator to deal with the pain and associated difficulty sleeping. I have been using it for several months and find it extremely helpful. I find it also helps with the emotional side of dealing with severe pain. My pain is more manageable, my sleep better in general, and I feel more resilient in dealing with it. I have also recommended this device for two of my psychotherapy clients; one dealing with the severe pain of RA, and related insomnia, anxiety and depression,  and one with PTSD with associated bio-emotional symptoms.I highly recommend this device and its FDA approval. It is another expansive scam.  Product does not do any thing The Fisher wallace device is no different than any other depression treatment. it works for a while, then stops. This suggests to me it is a placebo effect - a very expensive one since insurance doesnt cover it and it costs $700. Worse are the sponges that the company charges a ridiculous amount for.Frankly, I think its an overpriced rip off that should not be approved.