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T Santogrossi

Publications and source records attributed to T Santogrossi.

3 recordsLinked to original sources

Clinical results of the CLARION magnetless cochlear implant.

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.

Adult↗

Magnetic resonance imaging compatibility testing of the Clarion 1.2 cochlear implant.

OBJECTIVE: This study aimed to investigate the compatibility of the Clarion 1.2 magnet-containing cochlear implant with a 1.5-tesla (T) and 0.3-T magnetic resonance imager. BACKGROUND: Cochlear implants restore functional hearing to patients with sensorineural deafness. With the rapidly increasing number of patients with cochlear implants, there is a need to investigate the implant's magnetic resonance imaging (MRI) compatibility. METHODS: The authors tested the potential torque and force on the metallic components of the implant, heating of the implant and surrounding tissue, unintentional output, implant damage, and image distortion. Tests were performed in both a 1.5-T and 0.3-T MRI. RESULTS: The torque experienced by the implant in the 1.5-T MRI (0.19 nm) was large enough that it could potentially cause implant movement in some patients. An acceptable amount of torque (0.04 nm) was found in the 0.3-T MRI. Image distortion occurred in the area directly around the implant with a radius of up to 60 mm in the 1.5-T MRI and 100 mm in the 0.3-T MRI. In both MRI units, there was no detectable temperature increase or unintentional output. There was no implant damage except that with worst-case conditions, the internal magnet was demagnetized by 78.5% with the 1.5-T unit and 3.36% with the 0.3-T unit. CONCLUSIONS: The authors recommend patients with cochlear implants avoid imaging in a 1.5-T MRI. The results suggest that the 0.3-T MRI poses little or no risks to patients with cochlear implants.

Cochlear Implantation↗