Brief Title
CI532 - Early Experience Study
Official Title
Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
Brief Summary
To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.
Detailed Description
To compare speech perception and audiometric outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array at 3 months postactivation with their best preoperative hearing status.
Study Type
Interventional
Primary Outcome
Speech Understanding (% Correct) on AzBio Sentences in Quiet in the Implanted Ear
Condition
Sensorineural Hearing Loss, Bilateral
Intervention
Cochlear Nucleus CI532
Study Arms / Comparison Groups
Implanted
Description: Subjects who meet the specified inclusion criteria and are implanted with the CI532 cochlear implant
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
24
Start Date
May 2016
Completion Date
September 2017
Primary Completion Date
June 2017
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
Gender
All
Ages
12 Months - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02755935
Organization ID
CAM5660
Responsible Party
Sponsor
Study Sponsor
Cochlear
Study Sponsor
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Verification Date
January 2018