NCT01072409CompletedNot Applicable
Clinical Evaluation of the Nucleus 5 Cochlear Implant System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cochlear
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- CNC Monosyllabic Word Performance - Treated Ear
Study Overview
Brief Summary
To evaluate the performance of the Nucleus 5 Cochlear Implant System.
Detailed Description
Performance outcomes of newly implanted adult recipients using the Nucleus 5 Cochlear Implant System.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
CNC Monosyllabic Word Performance - Treated Ear
Time Frame: 12 months
CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Completed
Not Applicable
Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in AdultsHearing Loss, SensorineuralNCT03007472Cochlear96
Completed
Not Applicable
CI532 - Early Experience StudySensorineural Hearing Loss, BilateralNCT02755935Cochlear24
Terminated
Not Applicable
Implantation With the Nucleus CI532 Cochlear Implant in AdultsHearing LossNCT02677220Cochlear1
Completed
Not Applicable
Clinical Evaluation of a Cochlear Implant SystemSensorineural Hearing LossNCT03467399Cochlear46
Completed
Not Applicable
Clinical Investigation of the Nucleus® CI532 Cochlear ImplantHearing LossNCT02392403Cochlear45