Hybrid L24 New Enrollment Post Approval Study

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

Official Title
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Nucleus Hybrid L24 Implant System: New Enrollment Study

Conditions
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High Frequency Sensorineural Hearing Loss

Intervention / Treatment
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* Device: Nucleus Hybrid L24 Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nucleus Hybrid L24 Implant<br>Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant. | Device: Nucleus Hybrid L24 Implant<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | From pre-operatively through 3 years post-activation of the device | 
| Number of Device or Procedure Related Adverse Events |  | Up to 5 years post-activation of the device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition | 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. | Pre-operatively, up to 3 years post-activation of the device |