Abstract
A miniature, hermetically sealed implant was development and manufactured in several clinical and technical iteration steps based on the prototype of an implantable piezo-electric hearing-aid transducer described in Part 1 of the work presented here. The transducer is made of pure titanium (medical grade 2, ASTM F67) and designed to be implanted into the mastoid cavity. Transfer of mechanical oscillations to an ossicle in the middle ear is effected by a fixed directly coupling rod of pure titanium or via suitable coupling elements. The transducer is highly tuned with a resonance frequency in the range of 7-10 kHz, depending on the dynamic mass load. Below this resonance and down to low frequencies, the frequency response of elongation is smooth with a very small ripple of less than +/- 1 dB. Unlike the prototype, an increase in vibration amplitude of around 10 dB was achieved for a comparable power consumption. Vibration amplitude at low and middle frequencies is about 60 nm with a transducer voltage of 1 V, corresponding to an equivalent sound-pressure level of around 100 dB SPL at up to 1 kHz. At higher frequencies of up to 10 kHz, the output level increases to beyond 130 dB SPL. Nonlinear distortions at maximum volume (1 V) ...Continue Reading
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