This trial is active, not recruiting.

Condition hearing loss
Treatment ci532 cochlear implant
Sponsor Cochlear
Collaborator New York University School of Medicine
Start date May 2016
End date November 2017
Trial size 1 participant
Trial identifier NCT02677220, CAM5631, NCT02560987


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Subjects to be implanted with the CI532 cochlear implant in one ear
ci532 cochlear implant

Primary Outcomes

AzBio Sentence Recognition in Noise
time frame: 6 months post-activation

Secondary Outcomes

Glasgow Benefit Inventory
time frame: 6 months post-activation
Speech, Spatial, and Qualities of Hearing Scale
time frame: 6 months post-activation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Implantation With the Nucleus CI532 Cochlear Implant in Adults
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Cochlear.