Multichannel auditory brainstem implant: US clinical trial results.
Since 1994, a US Food and Drug Administration clinical trial evaluated the multichannel auditory brainstem implant (ABI) on 92 subjects with neurofibromatosis type 2 (NF2). The trial has shown that 85 per cent of patients receive auditory sensations. A small number of patients demonstrate a clinically significant degree of open-set sentence recognition in the sound-alone condition; however, when the ABI is combined with lip-reading cues, 93 per cent of patients demonstrate improved sentence understanding at three to six months. In addition, the majority of recipients report daily use of their devices, and satisfaction with the decision to receive the ABI.
Ebinger
K
K
Clinical Studies Department, Cochlear Corporation, USA.
Otto
S
S
Arcaroli
J
J
Staller
S
S
Arndt
P
P
D000293:Adolescent; D000328:Adult; D000368:Aged; D001933:Brain Stem / Q000601:surgery*; D002648:Child; D012048:Correction of Hearing Impairment; D005260:Female; D006313:Hearing Loss, Central / Q000150:complications / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016518:Neurofibromatosis 2 / Q000150:complications / Q000601:surgery*; D019919:Prosthesis Implantation / Q000379:methods*; D011601:Psychophysics; D013067:Speech Perception