No abstract

This paper reports initial results for the CLARION® Multi-Strategy™ Cochlear Implant, presently under investigational study in Europe. A magnetless implantable cochlear stimulator (ICS) with an ear-mold-supported headpiece was designed in response to an increasing demand for a magnetic resonance imaging (MRI)-compatible cochlear implant. Surgical technique, accompanying magnetless headpiece, and MRI compatibility were evaluated in 11 deaf patients (ages 6 to 62 years) who were implanted with a magnetless Clarion implant. Because of the headset mechanics, the ICS was implanted closer behind the ear than a magnet-containing ICS. The ICS-MRI compatibility was investigated with 1.5-and 0.3-T MRI. Results showed that the surgery was relatively safe and easy to learn. The headset was stable and reliable. The MRI compatibility tests indicate that the ICS poses no contraindication for patients needing MRI. Overall, the results suggest that the Clarion magnetless cochlear implant is relatively safe and easy to implant, is MRI-compatible, and functions well with the ear-mold-supported headpiece.

The objective of this study was to develop a method of cement microapplication using glass-ionomeric cement. The results of an experimental study to design a microapplication method of glass-ionomeric cement (Ionocem^®) are presented. Typical middle ear implant materials, as well as human temporal bones and middle ear ossicles, were used to test the efficiency of this application method. Two different versions of Ionocem^®, low and normal viscosity, were tested under different temperatures and with several application tools. Sufficient processing time could be achieved by cooling the cement down to 4°C. A subcutaneous insulin syringe with a milled-off tip proved to be cost-effective, efficient and versatile. Using this instrument, durable and secure cementation between the parts tested could be achieved. This method may be of significant importance in otologic research and microsurgical routine. In part 2, experimental animal results will follow, as the method portrayed was used to secure parts of a totally implantable middle ear hearing device.