VeRelief uses low level electrical stimulation waveforms to activate the auricular branch of the vagus nerve and great auricular nerves in the ear area. Over the past decade, studies consist of stimulating this branch of the vagus nerve for 20 minutes to up to 4 hours at a time.
We recommend using VeRelief for up to 10 minutes in one session, but you can safely use it for hours on a daily basis with no safety risks, as long as you don't have one of the listed contraindications and you are aware of the risks and precautions.
Auricular Vagus Nerve Stimulation Safety
This technology has been around for decades and has an extremely high safety profile. Below is a summary of the safety of electrical nerve stimulation, auricular vagus nerve stimulation, and the VeRelief device.
The summaries below apply to auricular vagus nerve stimulation ONLY. They do not apply to cervical vagus nerve stimulation, which is done on the front side of the neck. Cervical vagus nerve stimulation will have a different safety profile and different level of risk based on your underlying conditions.
General Safety of Transcutaneous Electrical Nerve Stimulation
- Using low level electrical nerve stimulation devices for up to 60-minutes per day has been demonstrated to be safe with no serious adverse events in over 18,000 sessions.
- Includes healthy subjects, neurological, and psychiatric patients.
- Most common side effects, while rare, include headache or fatigue following stimulation, and prickling and burning sensations during treatment at higher intensity settings above 2mA.
- Brain damage occurs at 6.3 A/m2. VeRelief has output 10 times less than the level when brain damage would occur.
General Safety of Auricular Vagus Nerve Stimulation
- Auricular vagus nerve stimulation is safe and feasible for various clinical interventions.
- In multiple studies with over 6,000 participants, there was no difference in risk of experiencing a side effect between active treatment and placebo (fake) treatment with up to 60 minutes of use.
- The incidence of side effects was 12.84/100,000 person-minutes-days of stimulation. I think this means that for every 100,000 people that use taVNS for at least 60 seconds, 12.84 people will experience a side effect, or 0.01%.
- 81% of studies used left side only, 12% used both sides, and 7% used right side only.
- No difference in the risk of developing ear pain, dizziness, headache, and skin redness compared to placebo (fake) stimulation.
General Safety of taVNS
- In 2018, a safety study demonstrated that in over 1,300 patients, taVNS was safe and well tolerated. Most common side effects included skin irritation or uncomfortable tingliness (18%) and headache (3.6%).
Auricular vs. Cervical Vagus Nerve Stim Safety
- Heart related side effects such as bradycardia and asystole occur in approximately 1 per 1,000 cases of those who stimulate cardiac (cervical) branches of the vagus nerve.
- “Stimulating the auricular vagus nerve avoides the possibility of directly and asymmetrically stimulating cardiac motor efferent fibers, which could result in unfavorable cardiac events. The taVNS combines advantagsous qualities including non-invasiveness, cost, easiness, and efficacy to make it an appealing intervention for neuropsychiatric illnesses.”
The Safety of the VeRelief Auricular Vagus Nerve Stimulator
VeRelief has an extremely high safety profile and was built according to the specifications of typical devices used in past independent research. However, the usability has been significantly improved.
Learn more about the Hoolest-sponsored studies at https://hoolest.com/pages/research.
If you have any additional questions, contact support at support@hoolest.com.