Local therapy is practiced for middle and inner ear diseases but is usually restricted to cases of ear drum perforation or repeated invasive intratympanic drug application. Perfusion of drugs on the round window or through the scalae of animals using a pump system suggests that the chronic local drug treatment might also be feasible in humans. However, drug delivery systems that are currently on the market involve repeated reimplantation if they are to be used for long-term drug supply. A bone-anchored, totally implantable micro-drug delivery system (MDS) for patient-controlled drug supply has been developed [Lehner et al., 1997]. In this study, we show the first successful long-term in vivo test of the MDS micro-pump in rats. The process of implantation and first functional tests will be described. The biomaterial used to manufacture the delivery system did not cause any inflammation reaction in any of the 9 animals successfully implanted. After activation of the micro-pump, the drug reservoir and port was found to be fluid-tight. Bolus applications of tetrodotoxin (TTX) to the round window induced a transient decrease of evoked brainstem responses. In 2 animals which carried the MDS for more than 8 months the proper functioning of the pumping device was examined in a 2–3 week interval over a 3 month period. The MDS can be autoclaved even after long-term implantation and can then be reused for subsequent implantations. Designed for life-long implantation in humans, the demonstration of an effective long-term drug supply to the inner ear using the MDS provides an encouraging first step towards future long-term drug treatment of the inner ear in humans.
Recently, an implantable hearing aid for rehabilitation of sensorineural hearing loss has been developed. One component of the device is the microphone for implantation into the posterior canal wall. The membrane of the microphone can be covered by skin, cartilage, or fascia, avoiding reduction in sound transmission at the same time. In the study presented here, the microphone was implanted into 50 cadaver specimens of human temporal bone. Localization of the microphone was determined by the anatomical situation of the facial nerve. The microphone and the piezoelectric transducer could be implanted in 78% of the temporal bones after total mastoidectomy. In the final version of the microphone, the size was 4.5 mm and total weight 400 mg.
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