N/A N=96 Treatment

Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults

Hearing Loss, Sensorineural

Bottom Line

View on ClinicalTrials.gov: NCT03007472 ↗

Enrolled (actual)

Serious AEs

16.7%

Results posted

Dec 2020

Primary outcome: Primary: Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone — 14.6; 60.9 percentage of correct words

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CI532 (Device); Nucleus 7 (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Cochlear
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Pre- to 6 Months Post-implantation Speech Recognition in Quiet in the Implanted Ear Alone	14.6; 60.9	—
SECONDARY Evaluation of Change in Pre and Post Implantation Speech Recognition in Noise Scores in the Implanted Ear Alone	14.8; 42.7	—
SECONDARY Change in Pre and Post Implantation Score on the Health Utility Index-3 (HUI3)	0.46; 0.64	—

Summary

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Eligibility Criteria

Inclusion Criteria

Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
Bilateral moderate sloping to profound hearing loss
Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
Proficient in English
Ability to complete testing -

Exclusion Criteria

Previous cochlear implantation
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
Duration of severe to profound hearing loss greater than 20 years
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, medical or social handicaps that would prevent completion of all study requirements-

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03007472). 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.