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Multicenter Study
. 2016 Jan;126(1):175-81.
doi: 10.1002/lary.25451. Epub 2015 Jul 7.

United States multicenter clinical trial of the cochlear nucleus hybrid implant system

J Thomas Roland Jr  1 , Bruce J Gantz  2 , Susan B Waltzman  1 , Aaron J Parkinson  3 ; Multicenter Clinical Trial Group
Collaborators, Affiliations
Multicenter Study

United States multicenter clinical trial of the cochlear nucleus hybrid implant system

J Thomas Roland Jr et al. Laryngoscope. 2016 Jan.

Erratum in

  • Erratum.
    [No authors listed] [No authors listed] Laryngoscope. 2021 Oct;131(10):2398. doi: 10.1002/lary.29822. Laryngoscope. 2021. PMID: 34514589 Free PMC article. No abstract available.

Abstract

Objectives/hypothesis: To evaluate the safety and efficacy of acoustic and electric sound processing for individuals with significant residual low-frequency hearing and severe-to-profound high-frequency sensorineural hearing loss.

Study design: Prospective, single-arm repeated measures, single-subject design.

Methods: Fifty individuals, ≥ 18 years old, with low-frequency hearing and severe high-frequency loss were implanted with the Cochlear Nucleus Hybrid L24 implant at 10 investigational sites. Preoperatively, subjects demonstrated consonant-nucleus-consonant word scores of 10% through 60% in the ear to be implanted. Subjects were assessed prospectively, preoperatively, and postoperatively on coprimary endpoints of consonant-nucleus-consonant words, AzBio sentences in noise, and self-assessment measures.

Results: Significant mean improvements were observed for coprimary endpoints: consonant-nucleus-consonant words (35.8 percentage points) and AzBio sentences in noise (32.0 percentage points), both at P < 0.001. Ninety-six percent of subjects performed equal or better on speech in quiet and 90% in noise. Eighty-two percent of subjects showed improved performance on speech in quiet and 74% in noise. Self-assessments were positive, corroborating speech perception results.

Conclusion: The Nucleus Hybrid System provides significant improvements in speech intelligibility in quiet and noise for individuals with severe high-frequency loss and some low-frequency hearing. This device expands indications to hearing-impaired individuals who perform poorly with amplification due to bilateral high-frequency hearing loss and who previously were not implant candidates.

Keywords: Cochlear implant; bimodal stimulation; electric-acoustic stimulation; hearing in noise; hearing preservation; hybrid cochlear implant.

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Figures

Figure 1
Figure 1
Image of implanted receiver stimulator and the processor for the Nucleus Hybrid Implant System.
Figure 2
Figure 2
(a) CNC word scores for subjects with < 10, 10–20, 20–30, and > 30 dB of hearing loss at 6 months post‐cochelar implant activation. The number of subjects in each category of hearing loss is shown. (b) AzBio +5 dB signal‐to‐noise ratio scores for subjects with < 10, 10–20, 20–30, and > 30 dB of hearing loss at 6 months post‐cochlear implant activation. The number of subjects in each category of hearing loss is shown. Abbreviations: CNC = consonant‐nucleus‐consonant; SNR = signal‐to‐noise ratio. [Color figure can be viewed in the online issue, which is available at www.laryngoscope.com.]
Figure 3
Figure 3
(a) The CNC word scores for subjects in each category of low‐frequency hearing loss. The number of subjects in each category of low‐frequency hearing loss is shown. (b) The AzBio +5 dB signal to noise ratio scores for subjects in each category of lowfrequency hearing loss. The number of subjects in each category of low‐frequency hearing loss is shown. Abbreviations: CNC=consonant‐nucleus‐consonant; SNR = signal‐to‐noise ratio. [Color figure can be viewed in the online issue, which is available at www.laryngoscope.com.]
See this image and copyright information in PMC

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