POTENTIAL RISKS AND COMPLICATIONS
The Vitality Smartcable
™
is very low risk when used in accordance with the instructions for use. No
serious adverse events have been reported with its predecessor device or in the scientific literature. If
you experience any side effects from device use stop treatment immediately. If in doubt, contact your
healthcare provider.
A 2018 systematic review analyzed 1322 participants (across 51 studies) who received transcutaneous
neuromodulation at the ear. The review found that only 2.6% of participants discontinued use due to
side effects, where the most common side effect reported was skin irritation at the stimulation site
which typically ceased shortly after use. The following side effects were reported in this review:
Tingling/pain/redness/itching at the site of electrode placement during long term application (16.7%)
Lightheadedness/dizziness (1.4%) Fatigue (0.5%) Shortness of breath (0.4%) Voice alteration/hoarseness
(0.3%) Abnormal heart rhythm (0.3%) if in doubt contact your doctor. NOTE: this review analyzed
studies using multiple different neuromodulation methodologies so the results cannot be extrapolated
to the Vitality Smartcable and are included only as reference information.
