The present multicentric clinical study involves 19 centres, 16 of them in German-speaking countries, 1 British, 1 Polish and 1 Hungarian. 60 postlingually deafened adults with a mean age of 47.5 years (20–70) and a mean duration of deafness of 5.3 years (0.5–20) have been evaluated with the MED-EL COMBI 40 cochlear implant which implements a high-rate continuous-interleaved-sampling strategy with 8 channels. Safety and effectiveness data have been collected. Speech perception tests include a 16-consonant, an 8-vowel, a sentence and a monosyllabic-word test in all languages and a 2-digit figure test in all languages but English. Test intervals are 1,3,6 months and 1 year after first fitting. 41 of the 60 postlingually deafened adult study patients have completed their 6-month evaluation. While their pre-operative monosyllabic-word score was 0%, their mean monosyllabic-word score 6 months after first fitting was 48% (8–90) with a median of 50%. The mean sentence understanding was 84% (24–100) with a median of 90%. The respective values for the 1-year evaluations with 25 patients are a mean of 50% (5–85), with a median of 60%, for the monosyllables and a mean of 89% (30–100), with a median of 97%, for the sentences.
In vitro experiments were performed to determine the compatibility of a cochlear implant at 0.2- and 1.5-T magnetic resonance (MR) imaging. Except for the torque at 1.5 T, all electromagnetic interferences remained within acceptable limits. MR imaging should be performed only if there is a strong medical indication, by following appropriate safety procedures. MR imaging at 0.2 T should be safe; at 1.5 T, however, the relative risks will have to be assessed.
Dimensions of the scala tympani were measured at eight different places of 1 3/4 turns of the cochlea, beginning at the round window. Height and width of the scala tympani do not decrease continuously but show enlargements in some places. The diameter of two types of cochlear implants were compared with the mean heights of the scala tympani. The data provide an anatomical basis for the development of cochlear prosthesis, which could be inserted for a longer distance as accomplished hitherto.
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