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