United States Multicenter Clinical Trial of the Cochlear™ Nucleus® Hybrid™ Implant System

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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.

Roland, J. T., Gantz, B. J., Waltzman, S. B., Parkinson, A. J. and The Multicenter Clinical Trial Group (2015), United States multicenter clinical trial of the cochlear nucleus hybrid implant system. The Laryngoscope. doi: 10.1002/lary.25451

Cochlear Americas is the sponsor of this multicenter US clinical trial on electric-acoustic stimulation. J.T.R. and B.J.G. are active members of the Cochlear Americas and Advanced Bionics Advisory Boards. The authors have no other funding, financial relationships, or conflicts of interest to disclose.

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