FAQ’s

PHYSICIAN FAQS

WHAT IS THE TREATMENT PLAN FOR STIVAX?
Based on clinical research the ideal standard of care is three (3) Stivax devices per patient. One device cycle is to be worn for 14 days, off for 7 days, then then another device reapplied. We suggest the patient come in between days 4-7 to check up on the patient’s progress, and for the Stivax device to be adjusted appropriately.

HOW OFTEN DOES THE DEVICE TURN ON AND OFF?
The device cycles on and off on its own at a 40 minute on 20 minute off interval. The device will be blinking during the 40 minute on cycle, and will not be blinking during the 20 minute off cycle.

WHAT ARE THE CONTRAINDICATIONS FOR PLACING A STIVAX DEVICE?
Pregnancy, cardiac pacemakers, hemophilia. Psoriasis vulgaris or infection in area of the percutaneous implantation of electrodes. Blood Thinners as well, but only due to the small prick of the lead wire.

WHY ARE BLOOD THINNERS A CONTRAINDICATION? WHAT ABOUT ASPIRIN, FOR EXAMPLE?
Since the Stivax electrodes need to be percutaneously implanted in the ear, there may be some minor bleeding. The same concern would be for injecting the patient with a B-12 shot – so the bleeding stops quickly.

WOULD “HEARING AIDS” BE A CONTRAINDICATION?
No. If the patient has only one hearing aid, for ease of use, the Stivax device may be placed in the opposite ear. If they have one in each ear this is still not an issue. The battery of the Stivax will not interfere or cause any issue with the battery of the hearing aide.

HOW MANY DEVICES CAN BE PLACED PER PATIENT?
The protocol is min 3 devices. Some may 1-2 additional, as per recommended by the doctor.

IS THE DEVICE PROGRAMMABLE?
Yes, the factory setting is set at a level 6 when initially turned on. The unit can be increased as high as level 16, or as low as level 1, by using the tuning key found In the device blister pack.

HOW DO I PROGRAM THE DEVICE?
To increase, slide the tuning key from the dark circle to the open circle and back, this will increase the device by 1. To decrease, slide the tuning key from the open circle to the dark circle and back.

WHERE ON THE PATIENT DO I PLACE THE STIMULATOR DEVICE?
The stimulator pack is to be placed on the trapezius muscle, above or below the clavicle.

IS THE DEVICE WATER RESISTANT?
Yes, however it is suggested to not submerge the device for long periods of time, as the adhesive will come off. Hot tubs, swimming pools, steam showers and water parks are not advised during treatment.

WHAT IS THE SHELF-LIFE (EXPIRY DATE) OF A STIVAX DEVICE?
2 years from date of manufacture, when the battery was tested at 100%. This label is on the back of each device box.

PATIENT FAQS

WHAT KIND OF PAIN DOES STIVAX REDUCE?
The Stivax PENS stimulator reduces pain regardless of the cause of the pain.

HOW DOES NEUROSTIMULATION WORK?
The device uses two small electrodes to stimulate nerves in the ear with a very low voltage electrical current. The small electrical current stimulates skin nerves in the ear which connect to the vagus nerve in the body. The vagus nerve affects pain signals that pass through the spinal cord going to the brain. The device causes the vagus nerve to turn down the pain signals going to the brain by affecting natural levels of pain modifying chemicals in the spinal cord and base of the brain.

HOW MUCH REDUCTION IN PAIN SHOULD BE EXPECTED?
In randomized controlled studies, a majority of patients with chronic pain described a 50% reduction in pain after the first device period, and further reductions in pain with the additional devices. Many patients who relied on pain medication could stop using their medicine for pain.

HOW LONG DOES IT TAKE TO GET TREATMENT?
Each treatment begins with a consultation and evaluation of suitability. A typical treatment program would be a minimum of 3 complete rounds of treatment, using 1 dispsoable Stivax device during each treatment. Each device works for 14 days. Each treatment cycle must be followed by 7 days off the device. The full course of treatment would last approximately 60 days. Patients wear the device day and night. They can shower with it, and go about their usual activities. After 14 days of wearing the device, patients return to their doctor for device removal – as its battery will be depleted.

HOW LONG DOES THE PAIN RELIEVING EFFECT LAST?
Patients have reported that the reduction in pain is typically long-term, and rarely have been any cases where a person needs to come back for another treatment for the same injury or pain. If a new injury occurs, the person may need additional treatment for that problem.

DOES NEUROSTIMULATION HURT?
Aside from the minor effect associated with applying the device (application and wearing) and the presence of the device for the duration of the treatment, there’s no pain associated with neurostimulation. In very few cases people have experienced some discomfort near the application site, and this is easily eliminated by adjusting the output of the device.

ARE THERE ANY SIDE EFFECTS?
There are no direct side effects from the Stivax device or treatment. Wearing the device requires minimal adustments in daily routines for people, and can be safely worn in the shower.

WHAT OTHER PROBLEMS CAN BE HELPED BY NEUROSTIMULATION?
The device is effective for the treatment of peripheral arterial disease. It has been shown to improve oxygen delivery to the skin and muscles in people suffering from poor circulation. Neurostimulation has relieved pain from migraines, neuralgias, neuropathies, and injury. It has helped in the treatment of addiction recovery and depression. Some patients have seen improvements in non-painful conditions such as vertigo or chronic dizziness.

DISCLAIMER:  Providers should consult their own billing and reimbursement sources for appropriate billing codes and current rates applicable to them. It is our understanding that Medicare and some commercial insurance companies are not covering electro-acupuncture or auricular vagus nerve stimulation devices such as Stivax at this time.