Implantation With the Nucleus CI532 Cochlear Implant in Adults

Stopped early · Not applicable

Conditions studied: Hearing Loss

In brief

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.

Key facts

Study ID

NCT02677220

Run by

Cochlear

People needed

1

Starts

2016-05-11

Expected to finish

2017-08-23

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• NYU Medical Center — New York, New York, United States

Full record on ClinicalTrials.gov

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