Identified risk Mitigation measures
Ineffective
treatment
Clinical Performance Testing. Nonclinical (bench)
performance testing. Characterization and verification of
technical parameters. Labeling.
Skin irritation Biocompatibility testing. Labeling.
Headaches Clinical performance testing. Labeling.
Dizziness Clinical performance testing. Labeling.
Electrical
shocks and
burns
Electrical safety and EMC testing. Software verification,
validation, and hazard analysis.
- Brown et al. mention that CES: "uses a weak electrical current, given to the ears or scalp. CES
is reported to reduce anxiety during withdrawal from drugs, but most clinicians are likely to
have difficulty referring to therapists experienced in this technique, and treatments are not
reimbursable by [most] insurance."^4 Through electrodes placed on the earlobes, the maxilla-
occipital junction, mastoid processes or temples, a current of up to four milliamps is passed
through the cranium, treating anxiety, depression and insomnia with minimal risk.
- The FDA proposes that CES remain a Class III device for depression and other uses.
- The general and psychotropic mechanisms are unknown. According to Mischoulon, CES may
affect endorphins, neurotransmitters and neuro-hormones; regulation of body energy flow;
the limbic system, reticular activating system, and hypothalamus; the vascular system, brain
neural firing patterns and default network connectivity; circadian regulation; and the
adaptogenic function (assisting the body to battle effects of chronic stress): “All these
