Frequently Asked Questions

The Vivally System is an FDA-cleared wearable neuromodulation device that treats overactive bladder (OAB) symptoms including urge urinary incontinence and urinary urgency. It uses closed-loop transcutaneous tibial nerve stimulation (TTNS) and is worn at home for just 30 minutes, 3 times per week.

Vivally delivers personalized electrical stimulation to the tibial nerve through the skin. Its proprietary closed-loop technology continuously senses your EMG (muscle response) and automatically adjusts therapeutic output in real time, optimizing treatment for your individual needs.

Yes. The Vivally System received FDA 510(k) clearance for the treatment of urge urinary incontinence and urinary urgency. It is the first and only wearable device with true physiologic closed-loop neuromodulation for OAB.

Closed-loop neuromodulation means the device continuously monitors your body's physiologic response (EMG signals) and automatically adjusts stimulation intensity in real time. Unlike open-loop devices that deliver a fixed output, Vivally adapts to your movement and individual physiology.

Each Vivally therapy session lasts 30 minutes. The recommended protocol is 3 sessions per week. You can complete sessions while doing everyday activities like watching TV, reading, or folding laundry.

No. Most patients describe the sensation as a gentle tingling or tapping. The Vivally System is non-invasive—there are no needles, no implants, and no surgery required.

Clinical results vary by patient. In the published multicenter FREEOAB study, patients showed statistically significant improvements in OAB symptoms. Your healthcare provider can discuss expected timelines based on your individual condition.

Yes. The Vivally System's closed-loop technology automatically adjusts stimulation as you move, keeping you in the optimal therapeutic range. You can walk around your home, do light activities, or sit comfortably during your session.

Yes, the Vivally System requires a prescription from a licensed healthcare provider (MD or NP). Take the self-assessment on our website and bring your results to your next appointment to discuss whether Vivally is right for you.

Overactive bladder is a condition characterized by a sudden, intense urge to urinate that is difficult to control, often accompanied by urge urinary incontinence (involuntary urine leakage) and urinary urgency. It affects millions of adults and can significantly impact quality of life.

Vivally is designed for adults diagnosed with overactive bladder symptoms including urge urinary incontinence and urinary urgency. It is a good option for patients seeking a non-invasive, drug-free, at-home alternative to medications or in-office procedures. Consult your healthcare provider to determine eligibility.

Coverage varies by insurance plan. Avation Medical's customer care team can help you understand your coverage options. Contact customercare@avation.com or call 888.972.5694 for assistance.

Two multicenter clinical studies support the Vivally System. The FreeOAB study (96 patients, FDA 510(k) K220454) showed 63.8% of patients had significant reduction in incontinence or void symptoms (p=0.007), with benefits sustained at 1 year and zero device-related serious adverse events. The ReduceOAB sham-controlled study (125 patients, 1:1 randomized) demonstrated 83.6% response rate (p=0.0031), with 49.1% of patients returning to normal in one or more symptoms.

In the ReduceOAB study, patients in the active arm experienced daily symptom improvements after 12 weeks of 3.73 fewer voids, 2.61 fewer leaks, and 3.76 fewer urgency episodes. In the FreeOAB study, improvements were 2.84 fewer voids, 1.91 fewer leaks, and 3.09 fewer urgency episodes daily. Quality of life improvements exceeded 200% of the minimally clinically important difference.

In the ReduceOAB sham-controlled study, 98.9% of patients reported satisfaction with the Vivally System, 98.9% found it easy to use, 100% said it was easy to fit into their daily routine, and 95.6% said they were likely to continue using Vivally to treat their OAB.

The Vivally System is non-invasive and was well-tolerated in clinical studies. In the FreeOAB study, zero device-related serious adverse events were reported. As with any medical device, discuss potential risks and benefits with your healthcare provider.

The Vivally System costs approximately $4,995 for a 3-year treatment period, plus $343 for gel cushions. This compares favorably to other OAB treatments: medications ($17,000), BOTOX ($6,500–$12,500), PTNS ($5,445–$13,995), sacral/tibial implants (over $23,000), and catheters ($12,405–$22,995) over the same period.

Payment options include commercial insurance payors, Medicare Advantage, and self-pay. Currently Medicare does not cover Vivally. For insurance cases, Avation manages all claims, billing, and appeals. For self-pay, Avation ships Vivally directly to the patient within 24 hours.

Yes. Vivally offers a 30-day return and refund option, extended to 90 days for self-pay patients. Self-pay patients also receive a 1-year disposable supply included.

Your healthcare provider submits a 1-page Rx form along with chart notes (most payors request documentation of two drug failures, behavioral therapy, and a bladder diary). You will also need to complete a patient agreement, PRIA agreement, and provide a copy of your insurance card. All documents are submitted to Avation at avation.com/prescriber-kit.

Potential CPT codes for the Vivally System include 99203 for the initial office visit and 98980 for Remote Therapeutic Monitoring (monthly).