Clinical Evaluation of the Cochlear Nucleus CI532 Cochlear Implant in Adults (SME)

Cochlear

Status: Completed

Conditions: Hearing Loss, Sensorineural

Treatments: Device: CI532; Device: Nucleus 7

Study type: Interventional

Funder types: Industry

Identifiers

NCT03007472

CLTD5685

Details and patient eligibility

About

The purpose of this study is to gather long-term data on the FDA approved CI532 cochlear implant, and CP1000 (Nucleus 7) sound processor

Full description

Appropriate candidates will receive a CI532 cochlear implant and be fit with the CP1000 sound processor. Imaging will be completed pre-op, intra-op, and post-op to assess implant location. Speech perception testing as well as subjective questionnaires will be administered over 12 months.

Enrollment: 96 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults 18 years or older who have a bilateral postlinguistic sensorineural hearing loss.
2. Limited benefit from amplification as defined by test scores of 40% correct or less in the ear to be implanted and 50% or less in the contralateral ear on a recorded monosyllabic word test I. Consistent with the Minimum Speech Test Battery (2011), it is required that all subjects be evaluated at 60 dBA presentation level.
3. Bilateral moderate sloping to profound hearing loss
4. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method
5. Proficient in English
6. Ability to complete testing -

Exclusion criteria

1. Previous cochlear implantation
2. Pre-linguistically deafened (onset of hearing loss at less than two years of age)
3. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
4. Duration of severe to profound hearing loss greater than 20 years
5. Diagnosis of retro-cochlear pathology
6. Diagnosis of auditory neuropathy
7. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
8. Unwillingness or inability to comply with all investigational requirements
9. Additional cognitive, medical or social handicaps that would prevent completion of all study requirements-

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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96 participants in 1 patient group

CI532/N7 study group

Experimental group

Description:

All subjects will receive a CI532 cochlear implant (intervention) and be fit with the CP1000 sound processor

Treatment:

Device: Nucleus 7

Device: CI532