Evaluation of performance with the COMBI40 cochlear implant in adults: a multicentric clinical study.
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 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.
Helms
J
J
Department of Otorhinolaryngology, University of Würzburg, Germany.
Müller
J
J
Schön
F
F
Moser
L
L
Arnold
W
W
Janssen
T
T
Ramsden
R
R
von Ilberg
C
C
Kiefer
J
J
Pfennigdorf
T
T
Gstöttner
W
W
Baumgartner
W
W
Ehrenberger
K
K
Skarzynski
H
H
Ribari
O
O
Thumfart
W
W
Stephan
K
K
Mann
W
W
Heinemann
M
M
Zorowka
P
P
Lippert
K L
KL
Zenner
H P
HP
Bohndord
M
M
Hüttenbrink
K
K
Hochmair-Desoyer
I
I
D000328:Adult; D000368:Aged; D003054:Cochlear Implants / Q000009:adverse effects; D003638:Deafness / Q000628:therapy; D005060:Europe; D005069:Evaluation Studies as Topic; D005260:Female; D005500:Follow-Up Studies; D005858:Germany; D006309:Hearing; D006801:Humans; D007802:Language; D008297:Male; D008875:Middle Aged; D010700:Phonetics; D011183:Postoperative Complications; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012449:Safety; D013067:Speech Perception