Implantation With the Nucleus CI532 Cochlear Implant in Adults

NCT ID: NCT02677220

Last Updated: 2019-03-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-11
• Study Completion Date: 2017-08-23

Brief Summary

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgical

Subjects to be implanted with the CI532 cochlear implant in one ear

Group Type: EXPERIMENTAL

CI532 cochlear implant

Intervention Type: DEVICE

Interventions

CI532 cochlear implant

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: collaborator

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

NYU Medical Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

CAM5631

Identifier Type: -

Identifier Source: org_study_id

NCT02560987

Identifier Type: -

Identifier Source: nct_alias