Hybrid L24 New Enrollment Post Approval Study

Not Applicable

Completed

Brief Summary: This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nucleus Hybrid L24 Implant	Nucleus Hybrid L24 Implant	Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.

Primary Outcome Measures

Name	Time	Method
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	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	Up to 5 years post-activation of the device

Secondary Outcome Measures

Name	Time	Method
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition	Pre-operatively, up to 3 years post-activation of the device	The AzBio Sentence Tests consists of 15 lists of 20 sentences each. AzBio sentences are spoken by different talkers in a conversational style with limited contextual cues that the listener can use to predict or 'fill in' unintelligible words. Each list includes 5 sentences from 4 different male and female speakers. Each word in the sentence counts toward the overall score and the resulting score is presented in percent correct. The AzBio sentence test has a score range of 0-100% with higher values indicating better scores.

Locations (19): Rocky Mountain Ear Center
🇺🇸
Englewood, Colorado, United States
Greater Baltimore Medical Center
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Baltimore, Maryland, United States
Pittsburgh Ear Associates
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Pittsburgh, Pennsylvania, United States
University of Colorado Hospitals
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Aurora, Colorado, United States
Arizona Ear Center
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Phoenix, Arizona, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
Michigan Ear Institute
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Farmington Hills, Michigan, United States
Lahey Hospital and Medical Center
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Burlington, Massachusetts, United States
University of Miami
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Miami, Florida, United States
Denver Ear Associates
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Englewood, Colorado, United States
Kaiser Permanente South Sacramento
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Sacramento, California, United States
NorthShore University Health System
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Northbrook, Illinois, United States
University of Iowa
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Iowa City, Iowa, United States
University of Michigan
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Ann Arbor, Michigan, United States
Midwest Ear Institute
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Kansas City, Missouri, United States
Ohio Ear Institute
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Westerville, Ohio, United States
The University of Cincinnati
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Cincinnati, Ohio, United States
Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States
Ear Institute of Texas
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San Antonio, Texas, United States