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.
The trial shows, that we can well use the German-APHAB for quality control in hearing aid fitting done in an ENT-office. Patients fitted in a German ENT-office score the same as patients fitted by US-audiologists. We will continue using the APHAB forms, analyse the scoring and use it for technical adjustments to increase the coaching for negative scoring patients.
A study was conducted to compare the new MED-EL TEMPO+ ear-level speech processor with the CIS PRO+ body-worn processor in the COMBI 40/COMBI 40+ implant system. Speech tests were performed in 46 experienced subjects in two test sessions approximately 4 weeks apart. Subjects were switched over from the CIS PRO+ to the TEMPO+ in the first session and used only the TEMPO+ in the time between the two sessions. Speech tests included monosyllabic word tests and sentence tests via the telephone. An adaptive noise method was used to adjust each subject’s scores to approximately 50%. Additionally, subjects had to complete a questionnaire based on their 4 weeks of experience with the TEMPO+. The speech test results showed a statistically significant improvement in the monosyllabic word scores with the TEMPO+. In addition, in the second session, subjects showed a significant improvement when using the telephone with the TEMPO+, indicating some learning in this task. In the questionnaire, the vast majority of subjects found that the TEMPO+ allows equal or better speech understanding and rated the sound quality of the TEMPO+ higher. All these objective and subjective results indicate the superiority of the TEMPO+ and are mainly attributed to a new coding strategy called CIS+ and its implementation in the TEMPO+. In other words, based on the results of this study, it appears that after switching over from the CIS PRO+ to the TEMPO+, subjects are able to maintain or even improve their own speech understanding capability.
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