Safety and Regulations
The devices have been tested for electrical safety and rendered safe. It consumes and generates less energy than most consumer electronic devices, and the energy cannot be felt by a normal person. They are compliant with the European CE requirements for safety. However, they have NOT been evaluated by any regulatory body, including the FDA and Health Canada. The company does not make any claim for long-term cures although the evidence shows that regular use may improve the user’s quality of life. All evidence have been based on actual available data with these devices and/or published evidence based on other tests based on similar parameters and scientific bases.
The most common reason one would not choose an oral route and would instead elect to use nasal or buccal routes is due to delays in onset of oral medications and due to gastric acid destruction and first pass metabolism of drug resulting in very low levels available to the blood stream. Failure to utilize the nose brain path also occurs with oral (and buccal) medications - resulting in much slower drug delivery to the brain. Interestingly, oral medications are also commonly refused by 30% of pediatric patients making them completely ineffective in this situation. Buccal medications also require a cooperative patient who will retain the medication within their buccal and sublingual mucosal areas and not swallow or spit it out. In fact, even when buccal medications are administered to volunteers in research settings, only about 56% remains in the oral cavity for absorption. Even nasal drug delivery can have problems depending on the delivery method. Yuen et al report that in % of pediatric patients they were unable to dispense drops into the nose due to resistance to this delivery technique. While nasal delivery is possible the majority of the time, to overcome these delivery issues a number of device have been developed that enhance delivery - these are discussed in the delivery techniques section of this web site.