Specific Absorption Rate and Current Densities in the Human Eye and Head Induced by the Telemetry Link of an Epiretinal Prosthesis

The fields induced in the human head by the wireless telemetry used for Second Sight Medical Product, Inc.´s epiretinal prosthesis system are characterized for compliance testing with international safety standards using a three-dimensional (3-D) finite-difference time-domain (FDTD) code in D-H formulation. The specific system under consideration utilizes an inductive link with a primary coil mounted on the subject´s eyeglasses and a secondary coil that is strapped on the eye, over the sclera. The specific absorption rate (SAR) and the current density have been obtained computationally for different relative positions of the primary and secondary coils to account for the relative misalignment of the two due to the movement of the eye with the implant. For a peak normalized current of 0.62 A in the primary coil at 10 MHz, the highest peak 1-g SAR was found to be 0.45 W/Kg, and the maximum root mean square (rms) current density averaged over a 1-cm² area was found to be 16.05 A/m², both of which are within the limits imposed by IEEE and ICNIRP safety standards. Simulations between 2 and 20 MHz indicated that the induced electric field values scale well with frequency, thus providing guidelines for the determination of the final frequency and input power requirements of operation for the telemetry system to meet safety standards.