Implantation With the Nucleus CI532 Cochlear Implant in Adults



Status:Terminated
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:3/14/2019
Start Date:May 11, 2016
End Date:August 23, 2017

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Trial Summary
Trial Overview
Inclusion Criteria
The aim of this study is to investigate the clinical benefit for patients implanted with the
Nucleus® CI532 cochlear implant.

The Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into
the cochlea through a straightening sheath.


Inclusion Criteria:

- Meet current cochlear implant criteria at the implanting center

- 18 years or older with bilateral sensorineural hearing loss

- Limited benefit from appropriate binaural hearing aids

- Moderate to profound hearing loss in the low frequencies and profound hearing loss in
the mid to high frequencies

- Preoperative unaided threshold between 40 and 65 dB HL, inclusively, at 250 Hertz (Hz)
and 500 Hz in the ear to be implanted

- Fluent speaker in the language used to assess clinical performance

Exclusion Criteria:

- Evidence of hearing loss prior to age 5

- Sensorineural severe to profound hearing loss greater than 20 years at and above
2000Hz

- Simultaneous bilateral implantation prior to the study

- Medical or psychological conditions that contraindicate undergoing general anesthesia
or surgery

- Cochlear anomaly that might prevent complete insertion of the electrode array

- Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve, or
central auditory pathway

- Active middle ear infection

- Tympanic membrane perforation

- Unrealistic expectations

- Unwillingness or inability co comply with all investigational requirements

- Patients with existing cerebral shunts or drains

- Recurrent episodes of bacterial meningitis
We found this trial at
1
site
NYU Medical Center
New York, New York 10016
?
mi
from
New York, NY
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