Hybrid L24 New Enrollment Post Approval Study
Purpose
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
Condition
- High Frequency Sensorineural Hearing Loss
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Ear to Be Implanted: - Normal to moderate hearing loss in the low frequencies with severe to profound mid to high frequency hearing loss in the ear to be implanted - CNC word recognition of 10-60% in the ear to be implanted Contralateral Ear: - Moderately severe to profound mid to high frequency hearing loss in the contralateral ear - CNC word recognition equal to or better than that in the ear to be implanted but not more than 80% correct
Exclusion Criteria
- not proficient in English - unwilling and/or unable to comply with the test protocol - deafness due to lesions of the acoustic nerve or central auditory pathway. - active middle-ear disease, with or without tympanic membrane perforation. - absence of cochlear development. - duration of severe to profound hearing loss of 30 years or greater
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Nucleus Hybrid L24 Implant |
Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. |
|
More Details
- Status
- Completed
- Sponsor
- Cochlear