N/A
Completed N=45
Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System
Source: ClinicalTrials.gov NCT01072409 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: CNC Monosyllabic Word Performance - Treated Ear — 56.8 percent correct
Summary
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CNC Monosyllabic Word Performance - Treated Ear |
56.8 | — |
Eligibility Criteria
Inclusion Criteria
- Eighteen years of age or older at the time of the study.
- Postlinguistic onset of bilateral severe-to-profound sensorineural hearing loss
- Bilateral severe-to-profound hearing loss that meets current cochlear implant criteria (<50% open-set sentence recognition in quiet scores in the ear to be implanted and <60% in the best-aided condition)
- English spoken as the primary language.
- Willingness to participate in and to comply with all requirements of the study
- Subject may receive bilateral simultaneous cochlear implants.
Exclusion Criteria
- Previous cochlear implant experience
- Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Normal hearing in one or both ears.
- Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
- Active middle-ear infection.
- Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.
Data sourced from ClinicalTrials.gov (NCT01072409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.