Hybrid L24 New Enrollment Post Approval Study

Cochlear52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

High Frequency Sensorineural Hearing Loss

Interventions

Nucleus Hybrid L24 ImplantDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Arizona Ear Center

Phoenix, Arizona, United States

Kaiser Permanente South Sacramento

Sacramento, California, United States

Outcomes

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

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.

Time frame: From pre-operatively through 3 years post-activation of the device

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

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.

Time frame: Pre-operatively, up to 3 years post-activation of the device

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.