CI532 - Early Experience Study

Cochlear

Status

Completed

Conditions

Sensorineural Hearing Loss, Bilateral

Treatments

Device: Cochlear Nucleus CI532

Study type

Interventional

Funder types

Industry

Identifiers

NCT02755935

CAM5660

Details and patient eligibility

About

To evaluate performance outcomes in patients implanted with the Cochlear Nucleus CI532 electrode array.

Full 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.

Enrollment

24 patients

Sex

All

Ages

12+ months old

Volunteers

Accepts Healthy Volunteers

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