N/A
N=24
CI532 - Early Experience Study
Sensorineural Hearing Loss, Bilateral
Bottom Line
View on ClinicalTrials.gov: NCT02755935 ↗Enrolled (actual)
24
Serious AEs
8.3%
Results posted
Feb 2018
Primary outcome: Primary: Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear — 53.5 percent correct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cochlear Nucleus CI532 (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear |
53.5 | — |
| PRIMARY Speech Understanding (% Correct) on AzBio Sentences in Noise in the Implanted Ear |
25.3 | — |
Summary
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
Eligibility Criteria
Inclusion Criteria
- Medical and audiological candidate for a CI532 cochlear implant per commercially approved, age appropriate, FDA indications
- Post-linguistically deafened
- Ability to complete age appropriate testing
Exclusion Criteria
- Previous cochlear implantation in the ear to be implanted
- Pre-linguistically deafened (onset of hearing loss at less than two years of age)
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
- Diagnosis of retro-cochlear pathology
- Diagnosis of auditory neuropathy
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
- Unwillingness or inability to comply with all investigational requirements
- Additional cognitive handicaps that would prevent participation on all study requirements
Data sourced from ClinicalTrials.gov (NCT02755935). 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.