Completed

NCT Number: NCT02379819

Hybrid L24 New Enrollment Post Approval Study

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

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Key information

Conditions

High Frequency Sensorineural Hearing Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Ear Center, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nucleus Hybrid L24 Implant

Device

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Nucleus Hybrid L24 Implant System: New Enrollment Study

Acronym: HNE

Important dates

Study start: 2015
Primary completion: 2022
Study completion: 2022
First posted: Mar 5, 2015
Registry last updated: Mar 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.