Testing a method for quantifying the output of implantable middle ear hearing devices.

This report describes tests of a standard practice for quantifying the performance of implantable middle ear hearing devices (also known as implantable hearing aids). The standard and these tests were initiated by the Food and Drug Administration of the United States Government. The tests involved measurements on two hearing devices, one commercially available and the other home built, that were implanted into ears removed from human cadavers. The tests were conducted to investigate the utility of the practice and its outcome measures: the equivalent ear canal sound pressure transfer function that relates electrically driven middle ear velocities to the equivalent sound pressure needed to produce those velocities, and the maximum effective ear canal sound pressure. The practice calls for measurements in cadaveric ears in order to account for the varied anatomy and function of different human middle ears.