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Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes
Journal article   Open access   Peer reviewed

Multicenter clinical trial of the Nucleus Hybrid S8 cochlear implant: Final outcomes

Bruce J Gantz, Camille Dunn, Jacob Oleson, Marlan Hansen, Aaron Parkinson and Christopher Turner
The Laryngoscope, Vol.126(4), pp.962-973
04/2016
DOI: 10.1002/lary.25572
PMCID: PMC4803613
PMID: 26756395
url
https://doi.org/10.1002/lary.25572View
Published (Version of record) Open Access

Abstract

The concept of expanding electrical speech processing to those with more residual acoustic hearing with a less-invasive shorter cochlear implant (CI) has been ongoing since 1999. A multicenter study of the Nucleus Hybrid S8 CI took place between 2002 and 2011. This report describes the final outcomes of this clinical trial. Multicenter, longitudinal, single-subject design. Eighty-seven subjects received a Nucleus Hybrid S8 CI in their poorer ear. Speech perception in quiet (Consonant-Nucleus-Consonant [CNC] words) and in noise (Bamford-Kowal-Bench Sentences-In-Noise [BKB-SIN]) were collected pre- and postoperatively at 3, 6, and 12 months. Subjective questionnaire data using the Abbreviated Profile for Hearing Aid Benefit (APHAB) were also collected. Some level of hearing preservation was accomplished in 98% subjects, with 90% maintaining a functional low-frequency pure-tone average (LFPTA) at initial activation. By 12 months, five subjects had total hearing loss, and 80% of subjects maintained functional hearing. CNC words demonstrated that 82.5% and 87.5% of subjects had significant improvements in the hybrid and combined conditions, respectively. The majority had improvements with BKB-SIN. Results also indicated that as long as subjects maintained at least a severe LFPTA, there was significant improvement in speech understanding. Furthermore, all subjects reported positive improvements in hearing in three of the four subscales of the APHAB. The concept of hybrid speech processing has significant advantages for subjects with residual low-frequency hearing. In this study, the Nucleus Hybrid S8 provided improved word understanding in quiet and noise. Additionally, there appears to be stability of the residual hearing after initial activation of the device. 2c.
Prospective Studies United States Humans Middle Aged Male Treatment Outcome Speech Perception - physiology Iowa Cochlear Implantation - methods Aged, 80 and over Adult Female Surveys and Questionnaires Aged Cochlear Implants Hearing Loss, Sensorineural - surgery Longitudinal Studies Hearing Tests United States Food and Drug Administration

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