Hybrid L24 New Enrollment Post Approval Study

Not Applicable

Completed

• Conditions: High Frequency Sensorineural Hearing Loss

• Registration Number: NCT02379819
• Lead Sponsor: Cochlear

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-29
• Study Start: 2015-02
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Primary Completion: 2022-04-14
• Study Completion: 2022-04-14
• Status Verified: 2023-02
• Results First Submitted: 2023-02-07
• Results First Submitted QC: 2023-03-10
• Last Update Submitted: 2023-03-10
• Results First Posted: 2023-03-13
• Last Update Posted: 2023-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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.

Trial Locations

Locations (19)

Arizona Ear Center; 🇺🇸 Phoenix, Arizona, United States

Kaiser Permanente South Sacramento; 🇺🇸 Sacramento, California, United States

University of Colorado Hospitals; 🇺🇸 Aurora, Colorado, United States

Denver Ear Associates; 🇺🇸 Englewood, Colorado, United States

Rocky Mountain Ear Center; 🇺🇸 Englewood, Colorado, United States

University of Miami; 🇺🇸 Miami, Florida, United States

NorthShore University Health System; 🇺🇸 Northbrook, Illinois, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Greater Baltimore Medical Center; 🇺🇸 Baltimore, Maryland, United States

Lahey Hospital and Medical Center; 🇺🇸 Burlington, Massachusetts, United States

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