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Cervella FDA-Cleared Cranial Electrotherapy Stimulator
$0.00

FAQs

 

How do I setup and operate the Cervella device?

Please watch the following video and read your Owner’s Manual completely prior to use.

 

 

General FAQs

  • Q: Do you offer financing?
    • You may take advantage of Affirm or PayPal Credit which offer various financing options (including interest-free ones). You may sign-up for Affirm or PayPal Credit at the Checkout page. You can also pay with Amazon Pay or your HSA or FSA credit card. NOTE: Payment options through Affirm are subject to eligibility, may not be available in all states, and are provided by these lending partners: affirm.com/lenders. CA residents: Loans by Affirm Loan Services, LLC are made or arranged pursuant to a California Finance Lenders Law license.
  • Q: Is Cervella covered by insurance?
    • Insurance coverage varies depending on type of insurance so please inquire with your insurance company. You can try to obtain insurance coverage for Cervella with a Letter of Medical Necessity which you can obtain from your doctor. Effective January 1, 2020, there is a dedicated billing code (HCPCS) for CES devices: "K1002- Cranial electrotherapy stimulation (ces) system, includes all supplies and accessories, any type," which can be used for insurance billing. Several of our customers were able to obtain insurance reimbursement for the device from their insurance companies. Please contact your insurance provider regarding the specific steps to obtain insurance reimbursement. In addition, you can use your Health Savings Account (HSA) or Flexible Spending Account (FSA) to purchase the Cervella medical device or take advantage of the six months same as cash offer (available through PayPal at checkout). Note: We cannot bill your insurance provider, Medicare or Medicaid directly for Cervella so you would have to purchase the device first and then seek reimbursement.
  • Q: Do I need a prescription or Medical Device Authorization and who can I get it from?
    • A: Yes, Cervella you need to obtain a Medical Device Authorization (MDA) from a licensed healthcare provider. We offer you two options for obtaining the Medical Device Authorization for your Cervella device: OPTION 1: Contact your licensed healthcare provider (e.g. your doctor, therapist) and obtain the Medical Device Authorization (MDA). For your convenience, the BUY page has a downloadable form, but your provider is free to use his/her form. You can then attach the completed form during checkout or have the provider e-mail or fax it to us directly. OPTION 2: If you do not have a healthcare provider, you may complete a short suitability questionnaire during check-out which will be shared, via a HIPAA-compliant process, with an independent, licensed healthcare provider for review and approval. Once the order and review are complete, we will ship you the device along with a copy of the approved MDA. If, for whatever reason, you are not found to be a suitable candidate for Cervella, you will be issued a full refund immediately. We reserve the right for the independent healthcare provider to contact you via e-mail or phone for any additional information. There is no extra cost to you for this service.
  • Q: If Cervella does not work for me, can I return it?
    • A: Yes, We offer a 30-day Money Back return policy, subject to a 15% restocking fee. Please visit the Terms and Conditions page for details (https://cervella.us/terms-and-conditions).

Medical FAQs

  • Q: Is Cervella approved by the FDA?
    • A: The FDA approved Cervella ("cleared" in FDA-speak) for treatment of anxiety and insomnia. You can read our FDA approval letter by looking us up at in the FDA database (https://www.accessdata.fda.gov/scrIpts/cdrh/cfdocs/cfpmn/pmn.cfm) and referencing our 510(k) number: K182311. When considering purchasing a Cranial Electrotherapy Stimulator (or any medical device for that matter), ensure that the device has received official FDA clearance/approval which requires documentation, testing, verification, and compliance activities by the medical device manufacturer. Several of the CES devices available on the Internet (especially on places like eBay) are sold by individuals or businesses that have never tested the device or obtained FDA approval so you are taking a risk of using an untested (and illegally marketed) device. Furthermore, verify that the business you are purchasing a medical device from is a FDA-registered medical device manufacturer that complies with the safety and quality standards mandated by the FDA. You can verify our Establishment Registration number: 3015491424 by checking the FDA database following this link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/TextSearch.cfm
  • Q: How soon will I start feeling better?
    • A: Most patients start feeling the positive effects of cranial electrotherapy stimulation within the first couple of weeks. Note that results vary and are dependent on your condition. Always consult your healthcare provider before starting Cervella and follow the treatment plan as directed. Anxiety is often reduced after a single treatment but may reoccur so consistent treatment sessions are recommended. Many patients suffering from anxiety find it useful to use Cervella at the onset of anxiety or before a high stress situation. Insomnia, especially if comorbid with anxiety, is often reduced after a single treatment but, like depression, consistent treatment sessions are recommended even when you are feeling better. When conditions improve, please use Cervella at reduced intervals or on an as-need basis as instructed by your healthcare provider.
  • Q: Who should not use Cervella?
    • A: There are no known contraindications for use of the Cranial Electrotherapy Stimulator. However, there are conditions where the use of a CES device has not been tested. Consequently, Cervella should not be used by patients with implanted medical devices such as pacemakers, implanted defibrillators, or medical devices implanted in the head or neck. Safety of stimulation has not been established during pregnancy. The device should not be used for people with irritated or broken skin around the ears (especially mastoid) which is the area of the electrode contact with the skin. Patients wearing hearing aids will have to remove the hearing aids prior to use of the headphones. Epilepsy patients should not be using the device without clinical supervision. Do not operate vehicles or dangerous equipment during treatment and within several hours post-treatment. Always consult your healthcare provider before using Cervella.
  • Q: What should I do if I experience headache, dizziness, nausea, or other adverse effects?
    • A: First, reduce the intensity level during treatment. Treatment sessions at current intensity levels higher than necessary may cause dizziness and nausea that can last several hours to a few days. Furthermore, it has been clinically validated that stronger current than a light, comfortable tingling sensation do not provide better clinical outcomes. In short, stronger stimulation current is not better. If you continue experiencing adverse effects or if you experience paradoxical reactions such as increased anxiety or continued insomnia, consult your healthcare provider immediately.
  • Q: Can I use Cervella together with medication?
    • A: Generally, yes, but always consult your healthcare professional for specific instructions based on your individual health condition.
  • Q: What is the optimal treatment duration and how often should I use the device?
    • A: The optimal and default treatment duration is 30 minutes. Treatments in excess of 1 hour are typically not necessary and treatments shorter than 20 minutes may not be effective.
  • Q: What is the best time to use Cervella?
    • A: For treatment of insomnia, the best time to use Cervella is about 3 hours prior to bedtime. For anxiety and depression treatment, Cervella can be used anytime or immediately prior to a potentially stressful or anxiety-inducing event. Note, some patients respond feeling very alert and energized after the treatment so for those patients it is not recommended that the device is used immediately before as it may cause difficulty in falling asleep.
  • Q: I have been using Cervella for a few days but I cannot yet tell whether it is working for my condition.
    • A: Unlike pharmaceuticals, which often seem to have some effect within a few days, CES therapy is a slower and gradual process, especially in more acute cases. Some patients feel the benefits of the treatment after only few treatment sessions by noticing improved sleep patterns and reduced anxiety (especially if used during an anxiety attack). For others, it takes a few weeks of daily treatments to see a marked improvement. If you don't respond immediately, please give it a bit more time. Remember, it is important that the device is used daily for full 30 minutes until conditions improve. Lastly, you can find additional answers to FAQs by following this link and at the bottom of Patient Info and Clinical Info pages.

Operation FAQs

  • Q: Can I listen to music and use the noise cancelling feature during treatment?
    • A: Absolutely. You can pair the headset to your smart device and use it as a wireless Bluetooth stereo headset with or without the ANC (Active Noise Cancellation) feature. Your headset can be paired with the same device that runs the Cervella app or with a different device (e.g. your computer).
  • Q: Can I use my smart device for both Cervella treatment and to stream audio to the headset?
    • A: Absolutely. Please remember, however, that you will establish two (2) independent Bluetooth connections: the first connection will be between the Cervella device and the Cervella App on your smart device, and the second connection will be used to stream audio from your smart device to the Cervella headphones. Note: avoid connecting additional Bluetooth devices to your smart device in order to ensure uninterrupted audio streaming experience.
  • Q: Which is the best frequency to use?
    • A: The default and most widely used and studied frequency for cranial electrotherapy stimulation is 100Hz. If the default frequency is not effective, please try 0.5Hz or 1.5Hz. In clinical research, the 100Hz seems to be a very good (effective) frequency (it is also one of the most widely studied) so that is why we use it as default.
  • Q: What should be the optimal treatment intensity level?
    • A: The optimal treatment intensity level is when you feel a slight tingling sensation due to current flow, but the sensation is never uncomfortable or painful. It has been clinically demonstrated that higher current levels do not result in better or faster clinical outcomes so only use the current level that is comfortable. Remember, it is much more important that you use the device for full 30 minutes during each session vs. using Cervella for a shorter duration at a higher setting.
  • Q: How do I know that my Cervella device is charging properly and holding charge?
    • A: When you charge your Cervella device, the Cervella LED should blink RED and turn solid GREEN when charge is completed. If you were to plug the Cervella into charger again after full charge, you will see the LED blinking RED again making you think the device is not holding charge. However, this is done on purpose in order to extend the lifespan of the battery inside the Cervella device. You see, the Li-Ion batteries do not like to be charged to 100% so we purposely do not "top off" the battery charge so that we can extend the battery number of charge cycles. That is also why when you go to the Pairing menu in the Cervella app after full charge you can often see the Cervella charge level to be 99% instead 100%. Your device is charging and operating exactly as intended.
  • Q: How do I know that the current is flowing and the Cervella device is operating properly during treatment?
    • A: There are two indicators. First, the LED on the Cervella box will be blinking BLUE. Second, the counter on the Cervella app will count down treatment time. If the LED is solid blue or the counter is stopped, you do not have a good contact between the gold electrodes of the headset and your mastoid area or you do not have the device connected properly. HINT: you can test the operation of the Cervella system by starting the treatment and just touching the two ear cushions together. You should see the LED blinking blue and timer counting down and stop as soon as you separate the ear cushions indicating a break in the connection. As always, please resist increasing current intensity level as stronger does result in faster or better clinical outcomes. Always use your Cervella at the lowest setting where the tingling sensation is just barely perceptible. Use small a small amount of gel. You can see the proper way to apply the gel by watching the Cervella set-up and operation video.

Clinician's FAQs

  • Q: How does Cervella work?
    • A: Cranial Electrotherapy Stimulators transmit small pulses of electric current across patient’s brain via a pair of conductive electrodes placed on patient’s forehead, mastoid or ear lobes. CES devices have been in existence for several decades and are cleared by the FDA for treatment of insomnia and anxiety. They exhibit good efficacy (especially for treatment of anxiety and insomnia) and have no significant contraindications. They present a very good alternative to drug therapies especially for patients that either exhibit low efficacy with drug-based therapies or experience significant side-effects with the drugs (usually SSRIs). During a treatment session, which typically lasts 30 minutes, patients suffering from anxiety and insomnia will experience reduction of anxiety immediately post-treatment and improved sleep patterns (insomnia reduction). Longer-term use has been clinically-validated to have a positive effect on reducing patient’s depressive mood.
  • Q: Is Cervella FDA-approved?
    • A: Yes, the FDA approved (cleared in the FDA-speak) the Cervella for treatment of Anxiety and Insomnia. Our FDA 510(k) clearance number is: K182311.
  • Q: Can Cervella be used in conjunction with drug-based therapies or cognitive based therapies?
    • A: Absolutely. Cervella is an excellent adjunct device and it does not interfere with either drug-based therapies or CBTs. Many patients love using Cranial Electrotherapy Stimulator in stressful or anxiety-inducing situations as anxiety-reduction can be experienced after just a few minutes of use.
  • Q: What are the potential side-effects for Cervella?
    • A: Cervella, like all CES devices, uses electric current transferred through patient skin. In order to avoid potential skin irritation, it is important that the patient keeps the skin clean and uses the conductive gel at the skin/electrode interface. Fortunately, if a patient forgets to clean his or her skin prior to use or forgets to apply the conductive gel, patient will experience a mild stinging sensation which will prompt him or her to apply conductive gel, reduce treatment intensity level, or ensure that the skin contact area is clean. Some patients may experience dizziness and light-headedness during or after treatment. This condition usually self-resolves. If the condition persists, ask the patient to lower the stimulation current.
  • Q: Who should not use Cervella?
    • A: There are no known contraindications for use of the Cranial Electrotherapy Stimulator. However, there are conditions where the use of a CES device has not been tested. Consequently, Cervella should not be used by patients with implanted medical devices such as pacemakers, implanted defibrillators, or medical devices implanted in the head or neck. Safety of stimulation has not been established during pregnancy. The device should not be used for people with irritated or broken skin around the ears (especially mastoid) which is the area of the electrode contact with the skin. Patients wearing hearing aids will have to remove the hearing aids prior to use of the headphones.
  • Q: What is the recommended treatment protocol for the Cervella?
    • A: The optimal and default treatment duration is daily treatment of 30 minutes for two weeks. Treatments in excess of 1 hour are typically not necessary and treatments shorter than 20 minutes may not be effective. Patient should experience reduction or anxiety and insomnia after the two weeks of daily treatment. Once the condition improves and stabilities, patients can go on a reduced treatment schedule and/or use the device on demand (e.g. before anticipated stressful event or during an acute anxiety attack).
  • Q: What is the best time to use Cervella?
    • A: For treatment of insomnia, the best time to use Cervella is about 3 hours prior to bedtime. For anxiety treatment, Cervella can be used anytime or immediately prior to a potentially stressful or anxiety-inducing event. It is not recommended, however, that Cervella is used immediately prior to bedtime as it may cause difficulty in falling asleep.