Abstract

Laser Doppler vibrometric (LDV) measurements on human temporal bones represent the standard method for predicting the performance of active middle ear implants (AMEI) and are used as preclinical tests in the development, approval process, and indication expansion of AMEI. The quality of the coupling of the floating mass transducer to the mobile structures of the middle ear is decisive for the performance of the implant and patients' hearing perception. The cochlea can be stimulated via the oval window (forward stimulation) or the round window (reverse stimulation). For forward stimulation, the ASTM standard F2504-05 defines amethod to ensure physiologically normal properties of the temporal bones used in the experiments. For reverse stimulation, which depends even more critically on the quality of the temporal bone, acomparable standard method is lacking. Appropriate preparation and storage of the human petrous bone as well as suitable LDV test setups with respect to calibration and reproducibility of measuring positions and angles provide results that allow acomparison of different types of coupling and also correlate well with clinical data.

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