title: Development and evaluation of the Nurotron 26-electrode cochlear implant system.
abstract: Although the cochlear implant has been widely acknowledged as the most successful neural prosthesis, only a fraction of hearing-impaired people who can potentially benefit from a cochlear implant have actually received one due to its limited awareness, accessibility, and affordability. To help overcome these limitations, a 26-electrode cochlear implant has been developed to receive China's Food and Drug Administration (CFDA) approval in 2011 and Conformité Européenne (CE) Marking in 2012. The present article describes design philosophy, system specification, and technical verification of the Nurotron device, which includes advanced digital signal processing and 4 current sources with multiple amplitude resolutions that not only are compatible with perceptual capability but also allow interleaved or simultaneous stimulation. The article also presents 3-year longitudinal evaluation data from 60 human subjects who have received the Nurotron device. The objective measures show that electrode impedance decreased within the first month of device use, but was stable until a slight increase at the end of two years. The subjective loudness measures show that electric stimulation threshold was stable while the maximal comfort level increased over the 3 years. Mandarin sentence recognition increased from the pre-surgical 0%-correct score to a plateau of about 80% correct with 6-month use of the device. Both indirect and direct comparisons indicate indistinguishable performance differences between the Nurotron system and other commercially available devices. The present 26-electrode cochlear implant has already helped to lower the price of cochlear implantation in China and will likely contribute to increased cochlear implant access and success in the rest of the world. This article is part of a Special Issue entitled <Lasker Award>.
authors.affiliation: Center for Hearing Research, University of California, Irvine, CA 92697, USA. Electronic address: fzeng@uci.edu.
authors.forename: Fan-Gang
authors.initials: FG
authors.lastname: Zeng
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, University of California, San Francisco, CA 94143, USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Rebscher
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, University of California, Los Angeles, CA 90095, USA.
authors.forename: Qian-Jie
authors.initials: QJ
authors.lastname: Fu
authors.affiliation: Nurotron Biotechnology Inc., Hangzhou, Zhejiang 310011, China.
authors.forename: Hongbin
authors.initials: H
authors.lastname: Chen
authors.affiliation: Nurotron Biotechnology Inc., Hangzhou, Zhejiang 310011, China.
authors.forename: Xiaoan
authors.initials: X
authors.lastname: Sun
authors.affiliation: Nurotron Biotechnology Inc., Hangzhou, Zhejiang 310011, China.
authors.forename: Li
authors.initials: L
authors.lastname: Yin
authors.affiliation: Nurotron Biotechnology Inc., Hangzhou, Zhejiang 310011, China.
authors.forename: Lichuan
authors.initials: L
authors.lastname: Ping
authors.affiliation: Shanghai Acoustics Laboratory, Institute of Acoustics, Chinese Academy of Sciences, Shanghai 200032, China.
authors.forename: Haihong
authors.initials: H
authors.lastname: Feng
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, Chinese PLA General Hospital, Beijing 100853, China.
authors.forename: Shiming
authors.initials: S
authors.lastname: Yang
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, Beijing Tongren Hospital of Capital Medical University, Beijing 100730, China.
authors.forename: Shusheng
authors.initials: S
authors.lastname: Gong
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Second Affiliated Hospital of Zhejiang University, Hangzhou 310000, China.
authors.forename: Beibei
authors.initials: B
authors.lastname: Yang
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China.
authors.forename: Hou-Yong
authors.initials: HY
authors.lastname: Kang
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Eye and ENT Hospital of Fudan University, Shanghai 200031, China.
authors.forename: Na
authors.initials: N
authors.lastname: Gao
authors.affiliation: Department of Otolaryngology - Head and Neck Surgery, The Eye and ENT Hospital of Fudan University, Shanghai 200031, China. Electronic address: chifanglu@yahoo.com.cn.
authors.forename: Fanglu
authors.initials: F
authors.lastname: Chi
mesh_terms: D000161:Acoustic Stimulation; D000162:Acoustics; D000293:Adolescent; D000328:Adult; D001302:Audiometry, Speech; D001306:Auditory Pathways / Q000503:physiopathology; D001307:Auditory Perception; D001309:Auditory Threshold; D002648:Child; D002681:China; D019929:Cochlear Implantation / Q000295:instrumentation*; D003054:Cochlear Implants; D004558:Electric Stimulation; D005260:Female; D006801:Humans; D008144:Loudness Perception; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D019986:Persons with Hearing Disabilities / Q000523:psychology / Q000534:rehabilitation*; D011474:Prosthesis Design; D020127:Recovery of Function; D012815:Signal Processing, Computer-Assisted; D013018:Sound Spectrography; D013067:Speech Perception; D055815:Young Adult