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.
With the clip prosthesis, it seems possible to further improve defective middle ear function, which would allow the patient to regain social hearing after middle ear reconstruction. The reliability of the fastening is an innovation. Revision operations showed a stable prosthesis-stapes complex in the middle of a recurring cholesteatoma and the prosthesis could always be easily pulled from the stapedial suprastructure.
In order to get a better insight into the function of the human middle ear it is necessary to simulate its dynamic behaviour by means of the finite-element method. Three-dimensional measurements of the surfaces of the tympanic membrane and of the auditory ossicles malleus, incus and stapes are carried out and geometrical models are created. On the basis of these data, finite-element models are constructed and the dynamic behaviour of the combinations tympanic membrane with malleus in its elastic suspensions and stapes with annular ligament is simulated. Natural frequencies and mode shapes are computed by modal analysis. These investigations showed that the ossicles can be treated as rigid bodies only in a restricted frequency range from 0 to 3.5 kHz.
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