Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults



Status:Active, not recruiting
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:4/17/2018
Start Date:December 2016
End Date:July 2019

Use our guide to learn which trials are right for you!

Clinical Evaluation of the Cochlear Nucleus(R) CI532 Cochlear Implant in Adults

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

Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound
processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant
location. Speech perception testing as well as subjective questionnaires will be administered
over 12 months.

Inclusion Criteria:

1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing
loss.

2. 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.

3. Bilateral moderate sloping to profound hearing loss

4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit
using the standardized NAL fitting method

5. Proficient in English

6. Ability to complete testing -

Exclusion Criteria:

1. Previous cochlear implantation

2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)

3. Ossification or any other cochlear anomaly that might prevent complete insertion of
the electrode array

4. Duration of severe to profound hearing loss greater than 20 years

5. Diagnosis of retro-cochlear pathology

6. Diagnosis of auditory neuropathy

7. 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

8. Unwillingness or inability to comply with all investigational requirements

9. Additional cognitive, medical or social handicaps that would prevent completion of all
study requirements-
We found this trial at
13
sites
Chesterfield, Missouri 63017
?
mi
from
Chesterfield, MO
Click here to add this to my saved trials
101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Dallas, Texas 75230
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Englewood, Colorado 80113
?
mi
from
Englewood, CO
Click here to add this to my saved trials
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
?
mi
from
New York, NY
Click here to add this to my saved trials
11500 Portland Avenue
Oklahoma City, Oklahoma 73120
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas 78240
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Spokane, Washington 99201
?
mi
from
Spokane, WA
Click here to add this to my saved trials