N/A N=45 Treatment

Clinical Evaluation of the Nucleus 5 Cochlear Implant (CI) System

Hearing Loss

Bottom Line

View on ClinicalTrials.gov: NCT01072409 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: CNC Monosyllabic Word Performance - Treated Ear — 56.8 percent correct

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nucleus 5 Cochlear implant (Device); Cochlear implantation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cochlear
Primary completion: Nov 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY CNC Monosyllabic Word Performance - Treated Ear	56.8	—

Summary

To evaluate the performance of the Nucleus 5 Cochlear Implant System.

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.

View full record on ClinicalTrials.gov →

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.