The Effect of Simulated Mastoid Obliteration on the Mechanical Output of Electromagnetic Transducers.

Background: The electromagnetic transducers of implantable middle ear hearing devices or direct acoustic cochlear implants (DACIs) are intended for implantation in an air-filled middle ear cavity. When implanted in an obliterated radical mastoid cavity, they would be surrounded by fatty tissue of unknown elastic properties, potentially attenuating the mechanical output. Here, the elastic properties of this tissue were determined experimentally and the vibrational output of commonly used electromagnetic transducers in an obliterated radical mastoid cavity was investigated in vitro using a newly developed method. Methods: The Young's moduli of human fatty tissue samples (3-mm diameter), taken fresh from the abdomen or from the radical mastoid cavity during revision surgeries, were determined by indentation tests. Two phantom materials having Young's moduli similar to and higher than (worst case scenario) the tissue were identified. The displacement output of a DACI, a middle ear transducer (MET) and a floating mass transducer (FMT), was measured when embedded in the phantom materials in a model radical cavity and compared with the output of the nonembedded transducers. Results: The here-determined Young's moduli of fresh human abdominal fatty tissue were comparable to the moduli of human breast fat tissue. When embedded in the phantom materials, the displacement output amplitude at 0.1 to 10 kHz of the DACI and MET was attenuated by maximally 5 dB. The attenuation of the output of the FMT was also minor at 0.5 to 10 kHz, but significantly reduced by up to 35 dB at lower frequencies. Conclusion: Using the method developed here, the Young's moduli of small soft tissue samples could be estimated and the effect of obliteration on the mechanical output of electromagnetic transducers was investigated in vitro. Our results demonstrate that the decrease in vibrational output of the DACI and MET in obliterated mastoid cavities is expected to be minor, having no major impact on clinical indication. Although no major attenuation of vibrational output of the FMT was found for frequencies >0.5 kHz, for implantations in patients the attenuation at frequencies

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