Implantation With the Nucleus CI532 Cochlear Implant in Adults

Cochlear

Status

Terminated

Conditions

Hearing Loss

Treatments

Device: CI532 cochlear implant

Study type

Interventional

Funder types

Other

Industry

Identifiers

CAM5631

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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