Frequently Asked Questions
If you do not see your question listed below, please chat with us online, call us, or email us and we will provide you with the information you need.
When used cranially to treat insomnia, depression and anxiety, 1 in 500 patients report a mild headache upon using the device.
Appoximately 1 in 250 patients may experience an increase in wakefulness immediately after using the device. If this occurs, the device should not be used within three hours of bedtime.
Although not a side effect, improper use of the device may result in minor electrode irritation - this can occur if the sponges are not thoroughly wet before use. Please watch the instructional video and read the instruction manual thoroughly before using the device. People with very sensitive skin may find that the sponge electrodes, even when wet, cause a slight irritation to the skin - but this is very rare.
The device delivers mild electrical stimulation to the brain through sponge electrodes placed above the sideburns. When used on the head, the device has been shown in medical studies to stimulate the production of neurochemicals, such as serotonin, GABA and endorphins, which are responsible for improving mood and sleep and suppressing chronic pain.
When used on the body to treat site-specific pain (the Chronic Pain Treatment Kit includes body straps to secure the electrodes and a special instruction manual), the electrical stimulation influences the way peripheral nerves signal pain, reducing the sensation of pain.
Ideally, you should use the device twice a day for 20 minutes until your symptoms go into remission. If you no longer have symptoms, you can stop using the device and then renew treatment if the symptoms return. The device has been on the market for decades without any reports of long-term negative effects. Many patients have used the device for years.
The electrical current is so gentle that many patients do not feel it at all, while some may feel tingling at the sponge contact sites. Mild optic nerve stimulation may also occur, which may produce the sensation of flashing light in the corner of the eyes - this is normal and harmless.
Many people report positive changes during or shortly after the first 5-10 treatment sessions. Results in treating insomnia are typically experienced faster than in treating depression and anxiety. The device should be used daily for 30-45 days before making a decision regarding effectiveness. While level 2 is the recommended starting dosage level, the device may be used safely at level 3 and 4, should level 2 not produce positive results after 30 days.
When being used to treat chronic pain (on the body), the device often reduces symptoms within a few treatment sessions.
The only patients who are not qualified to use our device are those with implanted medical devices, such as an implanted nerve stimulator or pacemaker, as the Fisher Wallace Stimulator® may interfere with the functioning of such devices.
Many private insurance companies, such as Aetna, United Healthcare and Blue Cross often reimburse patients for the purchase of a Fisher Wallace Stimulator® when it is prescribed for the treatment of pain using the procedure code E0720.
When the device is authorized only for the treatment of depression, anxiety or insomnia, the reimbursement rate decreases significantly. When the device is authorized for depression / anxiety / insomnia AND pain, patients will be able to have the device reimbursed more easily.
Fisher Wallace Laboratories is not in network with any insurance. Fisher Wallace Laboratories does not process reimbursement paperwork on behalf of its customers, but will assist customers throughout the process.
After purchasing your device, call your insurance company, provide them with the device reimbursement code (procedure HSPCS code) E0720 and the diagnosis code which should be supplied by your healthcare professional on the written authorization form. The insurance company will typically mail you a DME (Durable Medical Equipment) claim form that needs to be filled out and attached to the proof of payment. Your emailed receipt from Fisher Wallace contains all the information you will need, with the exception of the diagnosis code. The following information is often required by insurance companies to process a reimbursement (or payment) request:
Federal Tax ID # for Fisher Wallace Laboratories, LLC: 20-8131183
NPI #: 1497045215
Device Reimbursement Code (Procedure HSPCS Code): E0720
Patients who encounter difficulty receiving insurance approval may enhance their claim by submitting a letter from their doctor that describes the necessity of the device. You may download a template of this letter by clicking here . Your doctor will need to edit the template to reflect your particular situation.
The letter should be signed by your doctor and printed on the doctor's professional stationary.
MEDICARE & MEDICAID
Medicare & Medicaid will not reimburse patients for the purchase of our device at this time. To help deflect the cost, we offer a $100 discount to Medicaid recipients or members of military families. If you have a secondary insurance plan that covers the device, you will first need to receive a denial from Medicare for coverage in order to apply for reimbursement from the secondary insurance. To do so please call Medicare and ask for the 1490S Medicare form that you will need to fill out, attach your prescription, proof of payment and a cover letter stating that you are requesting a denial. All information needs to be sent to the Medicare Durable Medical Equipment address in your state (please call Medicare to obtain that address).
Office Visit Codes for receiving treatment by a doctor in the office:
G0283 Electrical Stimulation (unattended), to one or more areas for indications other than wound care, as part of a therapy plan of care.
To purchase a device using PayPal Credit (formerly Bill Me Later®), you must have a PayPal™ account (sign up here ). You can then select PayPal as your payment option when checking out and click PayPal Credit to finalize your purchase. Please call us, email us or chat with us if you have any questions.
Yes. Our device received multiple 510(k) clearances in 1991 which allow us to market the device for the treatment of depression, anxiety, insomnia and chronic pain. Click here to read the FDA definition of Cranial Electrotherapy Stimulation on the FDA website. Our technology should not be confused with Electroconvulsive Therapy (ECT) or Transcranial Magnetic Stimulation (TMS).
On June 12, 2014, the FDA officially announced that they will propose approval & reclassification of CES devices for the treatment of insomnia, depression and anxiety. You may read their announcement here.
There are several steps which must occur before the Agency officially approves CES, including the Agency's formal proposal for reclassification and the public comment period following such a proposal, but the Agency stated that is it has determined "that there is sufficient information to establish special controls, and that these special controls, together with general controls, will provide a reasonable assurance of safety and effectiveness for CES devices...FDA plans to issue a proposed order in the future for the reclassification of the CES device into Class II.
This decision is a watershed moment in the history of CES and demonstrates that the FDA is committed to supporting scientifically proven alternatives to drug therapy for the treatment of insomnia, anxiety and depression - the three symptoms most common to sufferers of PTSD, many of whom served our country in Iraq and Afghanistan. We applaud the Agency's position and look forward to the months that follow as the regulatory process unfolds.
Before you purchase your device , we must receive your prescription / written authorization from a licensed healthcare practitioner. There are two options for this:
Use Your Own Practitioner...
Have your practitioner (Primary Doctor, Psychologist, Psychiatrist, OBGYN, Chiropractor, Acupuncturist, Nurse or Physician's Assistant) fax or email this form or a prescription to 800.657.7362 / firstname.lastname@example.org . Click here for information to give to your practitioner.
...Or Call the Following Practitioner
For over-the-phone authorization, you may call the office of Sandy Root, L.Ac, seven days a week: 516.847-5277. Sandy Root is not compensated by Fisher Wallace and charges a $50 fee. If you reach voicemail, please leave a message and your call will be returned.
If your Fisher Wallace Stimulator® does not reduce or eliminate your symptoms within 60 days of receipt, send it back to us for a 100% refund. There is no restocking fee of any kind. You may use Flex Spending to purchase a device and you can submit your receipt to your health insurance company for reimbursement , depending on your plan.
To purchase a device using PayPal Credit (formerly Bill Me Later®), you must have a PayPal account ( sign up here ). You can then select PayPal as your payment option when checking out and click PayPal Credit to finalize your purchase. Please call us, email us or chat with us if you have any questions.
The Fisher Wallace Stimulator® and TMS are both non-invasive brain stimulation technologies that treat depression and other symptoms by stimulating the brain's production of neurotransmitters. However, there are significant differences between the technologies:
1. A series of TMS treatments typically costs $8,000 - $12,000 and is not covered by insurance. The Fisher Wallace Stimulator® costs $699 and is often reimbursed by insurance companies.
2. TMS uses high-powered magnets to induce an electrical charge in the brain. The Fisher Wallace Stimulator® does not use magnets – instead, it uses two AA batteries to deliver a gentle electrical current at patented frequencies via sponge electrodes placed underneath a simple headband. Therefore, our device may be used safely at home.
3. The FDA has only cleared TMS for the treatment of Major Depressive Disorder. The FDA has cleared the Fisher Wallace Stimulator® for the treatment of depression, anxiety, insomnia and pain.
4. TMS is administered in a doctor’s office, one reason why it is so expensive. The Fisher Wallace Stimulator® is designed to be used easily by patients at home. Our device is portable and weighs less than six ounces.
5. Despite the high cost, TMS comes with no guarantee of effectiveness. By contrast, you may return the Fisher Wallace Stimulator® for a 100% refund if it does not successfully treat your symptoms within 60 days of receipt.
If the Fisher Wallace Stimulator® does not reduce your symptoms of insomnia, anxiety, depression and/or pain within 60 days of receipt, you may return the device for a 100% refund.
The nation's top doctors recommend the Fisher Wallace Stimulator® for the safe, at-home treatment of insomnia, anxiety, depression and pain. Our device was cleared by the FDA in 1991 and causes no serious side effects. We offer discounts to patients with Medicare and to those who have served in the Armed Forces. Insurance companies often reimburse patients for the purchase of our device when it is used to treat pain. The Fisher Wallace Stimulator® gently stimulates the brain's production of neurochemicals responsible for improved mood, sleep and pain suppression. In multiple published studies, our technology has been proven to reduce insomnia, anxiety, depression and pain at rates that surpass drug therapy. You may return your device for a 100% refund within 60 days of receipt if it does not successfully treat your symptoms.
There are many differences between the Fisher Wallace Stimulator® and other Cranial Electrotherapy Stimulation (CES) devices on the market:
1. The Fisher Wallace Stimulator® generates a mild electrical current using patented frequencies unique to our device. The frequencies are responsible for stimulating neurochemical production.
2. The Fisher Wallace Stimulator® is the only CES device that the FDA has cleared for use directly on the head with sponge electrodes.
3. It is much easier and comfortable to use our device than earclip and patch devices, which require expensive accessories and gel.
4. Fisher Wallace is the only CES manufacturer with a world-class Medical Advisory Board comprised primarily of board certified psychiatrists.
5. The Fisher Wallace Stimulator® is completely manufactured in the USA, to a quality standard much higher than those of our competitors.
6. Fisher Wallace offers a 60-Day return & 100% refund policy on all devices. Our competitors offer only 30-Day return policies.
7. Over 1000 board certified psychiatrists prescribe the Fisher Wallace Stimulator®, more than any other CES device.
8. Only the Fisher Wallace Stimulator® is being used at Harvard hospitals, such as Massachusetts General Hospital.
Cranial Electrotherapy Stimulation (CES) devices such as the Fisher Wallace Stimulator® are cleared by the FDA for the treatment of insomnia, anxiety, depression and pain.
Transcranial Direct Current Stimulation (tDCS) is not cleared by the FDA for the treatment of depression, anxiety, insomnia or pain. tDCS was FDA approved in 2004 for Iontophoresis, which is a noninvasive method to deliver medicine or other chemicals through the skin with external patches and a small electrical charge. Transcranial Direct Current Stimulation (tDCS) is not typically an at-home treatment modality, and as a result, can be very expensive because it often requires office visits and doctor supervision during treatment sessions. Insurance companies will not reimburse patients for purchasing or using tDCS for “off label” uses such as the treatment of depression.
The Fisher Wallace Stimulator® and ECT both deliver alternating current to the brain for therapeutic effect, but at vastly different doses. The Fisher Wallace Stimulator® provides very gentle stimulation therapy designed for daily home use without doctor supervision - it does not cause a seizure or serious side effects. ECT, while often effective, is performed in a hospital while the patient is under anesthesia and is designed to induce a seizure. ECT often causes memory loss. Following are more differences:
1. ECT delivers 800 – 1000+ mA of electricity, which causes a seizure.
The Fisher Wallace Stimulator® delivers 1 – 4 mA of electricity, which does not cause a seizure. In fact, the Fisher Wallace Stimulator® is recommended for treating substance abuse patients who are prone to seizures.
2. ECT is administered when a patient is under anesthesia.
The Fisher Wallace Stimulator® delivers such a mild current that patients typically wear it while reading a book, on the computer or watching TV. The stimulation from our device is rarely perceived and is not uncomfortable.
3. ECT delivers a large amount of electricity in a single dose.
The Fisher Wallace Stimulator® delivers a gentle amount of electricity on a daily basis.
4. ECT typically costs $30,000 and, while effective initially, its effects wear off.
The Fisher Wallace Stimulator® costs $699 and the effects do not wear off when the device is used on a regular basis.
5. ECT is indicated to treat severe depression.
The Fisher Wallace Stimulator® can be used to treat temporary or situational depression as well as chronic, severe depression. Our device has also been cleared by the FDA for the treatment of anxiety, insomnia and pain.