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How to use
What is the recommended treatment protocol?
To treat depression or anxiety, patients should use the Fisher Wallace Stimulator® twice a day for 20 minutes on Level 2, once after waking up for the day and again before bed. To treat insomnia only, patients should use the device for 20 minutes on Level 2 before bed. It is important to create a consistent routine of daily usage.
If symptoms go into remission (no symptoms), patients may continue using the device to maintain results. There are no withdrawal effects associated with decreasing or stopping use of the device.
The device may be safely used with antidepressants and/or other medications. Do not reduce or stop taking your medication without first speaking to your doctor.
What activities may I do while using the device?
Resting quietly is best during a treatment session, but it’s fine to do other activities such as reading, watching TV, using the computer, or talking on the phone.
How soon will I experience benefit?
Most patients experience benefit in the first 1-4 weeks of daily treatments, but some can see results even faster. The device should be used daily for at least 2 weeks before making a decision to keep it or return it.
May I use the device in combination with medication?
Yes. The device does not negatively interact with any medication.
Should I use the device every day?
It’s recommended that you use the Stimulator® for 20 minutes a day until symptoms go away. When depression, anxiety and/or insomnia symptoms are completely resolved, you may stop using the device. If you feel that your symptoms are significantly reduced but did not go away completely, you may continue to use the device daily. Many people continue using their device after their symptoms go away because they find they can focus and concentrate better, which are additional benefits that the device provides.
Is there anyone who should NOT use the device?
The device should not be used on or near areas of the body, including the head, that contain implanted devices, such as stimulators, stents, or active or inactive implants such as deep brain stimulators and vagus nerve stimulators").
- Do not use this device around the Carotid sinus.
- If you have known or suspected heart disease, you should not use the Stimulator®.
- The device should not be used by persons who have known or suspected trigeminal neuralgia.
- If you are pregnant, you should not use the Stimulator®.
- If you have reacted poorly to the idea of electrical stimulation of any kind, you should not use this device.
- Discontinue use if your skin becomes irritated around either electrode site.
- This device must be used only for the purpose for which a physician or healthcare professional has prescribed or authorized.
- This device must only be used by the person for whom the prescription or authorization has been written.
How it works
How can I tell if the device is working?
If the green indicator light AND at least one yellow light are illuminated, the device is delivering stimulation. If there is no yellow light illuminated, the sponges may not be sufficiently moist, or the batteries may need to be replaced.
What does the stimulation feel like?
Many patients do not feel the stimulation at all, while some may feel a mild tingling at the sponge contact sites.
How does the device help me feel better?
The Fisher Wallace Stimulator® works by gently stimulating your brain to produce certain naturally occurring chemicals that improve mood. One of these chemicals is serotonin, known as the body’s mood regulator. The Stimulator also promotes alpha waves, which have a calming effect on the body. Additionally, the device helps to lower cortisol, your body’s stress hormone. The Stimulator treats insomnia but is not a sedative - instead, the device helps your brain produce a restful state that accelerates sleep onset and enables longer periods of sleep.
How long should I use the device?
Ideally, you should use the device twice a day for 20 minutes until your symptoms go away. If you no longer have symptoms, you can stop using the device and then renew treatment if symptoms return.
Are there side effects?
Less than 1% of patients report a mild, temporary headache or dizziness when using the device.
Although not a side effect, improper use of the device may result in minor skin irritation beneath the electrode sites - this can occur if the sponges are not thoroughly wet before use or if the scalp and/or hair are not clean. Please watch the instructional video and read the instruction manual thoroughly before using the device.
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.
What is the difference between FDA-Cleared and FDA-Approved?
Depending on risk, some medical devices require 510(k) clearance, and some devices require premarket approval. The Fisher Wallace Stimulator is FDA-cleared to treat depression, anxiety and insomnia.
How many people use the device?
How many healthcare professionals have prescribed the Fisher Wallace Stimulator®?
Over 14,000 licensed healthcare providers have prescribed the Fisher Wallace device since 2009.
How many people are using the device?
The Fisher Wallace Stimulator® has been used by over 85,000 patients in the United States.
How long has The Fisher Wallace Stimulator® been on the market?
The device was cleared by the FDA for the treatment of depression, anxiety and insomnia since 1990. The Fisher Wallace Stimulator® has been regulated for use longer than any other wearable neurostimulation device on the market.
Insurance and prescriptions
Is the device an FSA/HSA eligible expense?
Yes, it is eligible for FSA/HSA reimbursement.
Will my insurance cover the cost of the device?
Most insurance plans do not currently cover wearable brain stimulation treatments, but we are working on expanding coverage. For now, the vast majority of our customers purchase the device out-of-pocket, and many leverage their FSA/HSA to do so.
Which insurance providers cover the cost?
Medicaid in Maine (MaineCare) has approved the device. TRICARE For Life also covers the purchase of a Fisher Wallace Stimulator® if reimbursement is first rejected by Medicare. This benefit applies to any veteran -- or immediate family member of a veteran -- who is either (1) retired from the armed services and over 65 or (2) on permanent disability and under 65. Use the Medical Code: E1399 NU and the Provider Number: 1497045215. Reimbursement claims should be submitted directly to TRICARE For Life. A letter of medical necessity from a TRICARE for Life provider is often necessary to obtain reimbursement.
Do I need a prescription from my personal doctor?
We offer a simple, free prescription process that occurs during checkout. You just need to answer a short form (seven questions) and your answers will be confidentially reviewed by a provider licensed in your state via our telehealth partner.
If you prefer to handle the prescription through your doctor, please use this form.
What questions are asked in the online prescription process?
- Do you have any implanted electronic medical devices, such as a pacemaker or deep brain stimulator
- Do you have, or suspect you have, heart disease?
- Have you ever been diagnosed with Trigeminal Neuralgia?
- Are you pregnant?
- Are you experiencing any symptoms of depression or anxiety, or do you have trouble falling asleep or staying asleep?
- Date of birth
How do I pay with Klarna?
Klarna offers customers an option to pay $0 upon purchase, followed by monthly payments. There are two options, 6 monthly payments or 12 monthly payments. You will know if you are approved in seconds, and then can complete your purchase. You will receive an email notification of your purchase from Klarna, and can manage your account at www.klarna.com. The $499 breaks down to $84/month for 6 months interest free.
Is the Fisher Wallace Stimulator® different from other stimulation devices?
How does the Fisher Wallace Stimulator® differ from Transcranial Magnetic Stimulation (TMS)?
The Fisher Wallace Stimulator® has been cleared by the FDA for the treatment of insomnia, anxiety and depression. TMS is cleared by the FDA to treat depression, but not anxiety or insomnia, and is not an at-home treatment modality.
According to the FDA, TMS also poses a risk of seizure. The Fisher Wallace Stimulator® does not cause seizure or any other serious side effects.
How does the Fisher Wallace Stimulator® differ from Transcranial Direct Current Stimulation (tDCS)?
Neurostimulation devices such as the Fisher Wallace Stimulator® are cleared by the FDA for the treatment of insomnia, anxiety and depression.
Transcranial Direct Current Stimulation (tDCS) is not cleared by the FDA for the treatment of depression, anxiety or insomnia. 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.
How does the Fisher Wallace Stimulator® differ from Electroconvulsive Therapy (ECT)?
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 $499 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 and insomnia.
How to assemble
How do I set up the device?
Please view our instructional video for an overview of the process. The device is very simple to use and inexpensive and easy to maintain.
How do I know if I assembled the device correctly?
If the green indicator light AND at least one yellow light are illuminated, the device is delivering stimulation. If there is no yellow light illuminated, make sure that:
- The sponges are thoroughly wet.
- The headband is wrapped tightly around your head.
- You have pushed your hair out of the way of the electrodes.
- The batteries are fresh/fully charged.
NOTE: Battery placement
Batteries must be placed into the battery compartment with correct orientation, as shown in the diagram, for the device to perform.