Nucleus Hybrid L24 Extended Duration Post Approval Study

Hearing Loss Clinical Trial

— HED  

Official title:

The Nucleus Hybrid L24 Implant System: Extended Duration Post Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379273
• Other study ID #: CAM-5563-HYB-PMA
• Status: Completed
• Phase: N/A
• Start date: January 14, 2015
• Est. completion date: March 18, 2019

Study information

• Verified date: October 2021
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This post approval study evaluates the long term safety and efficacy of the Nucleus Hybrid L24 Implant System in a group of already implanted recipients.

Description:

The Hybrid L24 Implant System (P130016) was the subject of a pivotal clinical trial (IDE G070191) from 2007 through 2012. Data on the 50 subjects enrolled in the study, in support of safety and efficacy of the device, was submitted in June 2013 as part of Premarket Approval (PMA) #130016. As a condition of approval, March 20, 2014, a Post-Approval Study was designed to monitor the long-term (5 years postactivation for each subject) safety and effectiveness of the device in this existing cohort of implanted subjects was designed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 18, 2019
• Est. primary completion date: March 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recipients who were implanted with the Hybrid L24 as part of the original pivotal IDE study

Exclusion Criteria:

• Recipients who withdrew or were terminated from the L24 pivotal IDE study

• Recipients who were re-implanted and no longer have a Nucleus Hybrid L24 implant

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Nucleus Hybrid L24 Implant
Subjects have already been implanted with the Nucleus Hybrid L24 implant.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Cochlear	Hearts for Hearing, Mayo Clinic, Midwest Ear Institute, NYU Langone Health, Ohio State University, The Center for Hearing and Balance Disorders, University of Cincinnati, University of Iowa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet: Percentage of Total Words Correctly Recognized.	The CNC Words test consists of 10 recorded lists of 50 monosyllabic words in compact disk format. For this study, two lists were administered in quiet at a level equal to 60 dBA (decibels A-weighted) in the sound field and scored as total number of words correct, which will be expressed as a percentage correct. Minimum score is 0/100 words or 0% (worse), maximum score is 100/100 or 100% (best possible).	5 years postactivation.
Primary	AzBio (Arizona Biomedical Institute) Sentence Recognition in Noise: Percentage of Total Words Correctly Recognized.	The AzBio Sentence Test 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 towards the overall score. Minimum score is 0 out the total number of words in a given list (varies list to list, with an average length of 141 words) words or 0% (worse), maximum score is all words correctly repeated or 100% (best possible).	5 years postactivation.