Nucleus Hybrid L24 Implant System: New Enrollment Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Cochlear
- Enrollment
- 52
- Locations
- 19
- Primary Endpoint
- Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device
Study Overview
Brief Summary
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Nucleus Hybrid L24 Implant
Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.
Intervention: Nucleus Hybrid L24 Implant (Device)
Outcomes
Primary Outcomes
Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device
Time Frame: From pre-operatively through 3 years post-activation of the device
The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in CD format. For this study, two lists will be administered in quiet at a level equal to 60 dBA in the sound field and recorded as a total number of words correct, which will be expressed as a percentage correct for this study. The CNC word test has a score range of 0-100% with higher values indicating better scores.
Number of Device or Procedure Related Adverse Events
Time Frame: Up to 5 years post-activation of the device
Secondary Outcomes
- Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition(Pre-operatively, up to 3 years post-activation of the device)