CI532 – Early Experience Study

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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

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02755935

Organization ID

CAM5660


Responsible Party

Sponsor

Study Sponsor

Cochlear


Study Sponsor

, , 


Verification Date

January 2018