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

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. LEVEL OF EVIDENCE: 2b. Laryngoscope, 126:175–181, 2016