Implantable hearing device performance measured by laser Doppler interferometry.

Recent application of the Doppler principle laser interferometry to audiology, acoustics and otology has facilitated the development of implantable hearing devices (IHDs). During the design and testing of two different electromagnetic middle ear implants for sensorineural hearing loss, we used single-point laser Doppler interferometry (LDI). A commercially available interferometer, internally calibrated and validated against a National Institute for Standards and Technology (NIST) standard, was used with both mechanical fixtures and fresh temporal bones to evaluate implant mass, shape and orientation, attachment, electromagnetic coupling and acoustic properties. At both Hough Ear Institute and Symphonix Devices, Inc., we have shown that high fidelity and amplitudes can be recorded in vitro over a frequency range of 500 Hz to 10 kHz. These data can provide greater assurance of safety and efficacy to regulatory agencies before entering clinical trials. We propose that LDI be considered as an international standard for accurate, consistent comparison of performances of all IHDs during development. Furthermore, the future availability of human IHD data will allow for the extrapolation of a mechanical bench model of the middle ear transfer function for use in quality control during manufacturing and diagnosis of failure in IHDs.