Evaluation of Performance with the COMBI 40 Cochlear Implant in Adults: A Multicentric Clinical Study

TLDR

The study enrolled 60 postlingually deafened adults across 19 centers, evaluating the MED‑EL COMBI 40 cochlear implant—an 8‑channel high‑rate continuous‑interleaved‑sampling device—using a battery of speech perception tests (consonants, vowels, sentences, monosyllables, and 2‑digit figures) at 1, 3, 6 months and 1 year post‑fitting. At 6 months, 41 patients achieved a mean monosyllabic-word score of 48% (range 8–90) and a mean sentence score of 84% (range 24–100), while at 1 year, 25 patients reached mean monosyllabic and sentence scores of 50% (5–85) and 89% (30–100), respectively, indicating significant safety and effectiveness of the COMBI 40 implant.

Abstract

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.