Electrical safety assessment of a prototype device for electromagnetic stimulation of the ear in patients with tinnitus

Abstract

<b><br>Aim:</b> The aim of the study was to evaluate the results of electrical safety results of a prototype electromagnetic ear stimulation device in patients with tinnitus.</br> <b><br>Material and methods:</b> The electrical safety tests of the prototype device for electro- and magnetostimulation of the hearing organ were carried out at the Center for Attestation and Certification Tests in Gliwice. The tests concerned selected parameters including the PN-EN standard.</br> <b><br>Results:</b> Safety studies of the prototype electrical stimulation device for the ear in patients with tinnitus were necessary to perform the planned further preclinical studies. Obtained results regarding: identification and labeling of the device; protection against electric shock; checking protective earthing, functional earthing and potential equalization; checking the leakage current and auxiliary currents of the patient; checking the distances through the solid insulation and the use of thin insulating spacers; checking the electrical strength of the device insulation; checking protection against mechanical hazards of the device; checking the risk associated with surfaces, corners and edges, and checking the protection against excessive temperatures and other threats comply with the standard PN-EN.</br> <b><br>Conclusions:</b> No risk to the patient and medical staff. Tests of protection against mechanical hazards of the device have shown that the only movable part whose contact with the patient could cause an unacceptable risk is the fan installed inside the housing.</br>