High Frequency Sensorineural Hearing Loss Clinical Trial
— HNEOfficial title:
Nucleus Hybrid L24 Implant System: New Enrollment Study
| Verified date | February 2023 |
| Source | Cochlear |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | April 14, 2022 |
| Est. primary completion date | April 14, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | University of Colorado Hospitals | Aurora | Colorado |
| United States | Greater Baltimore Medical Center | Baltimore | Maryland |
| United States | Lahey Hospital and Medical Center | Burlington | Massachusetts |
| United States | The University of Cincinnati | Cincinnati | Ohio |
| United States | Denver Ear Associates | Englewood | Colorado |
| United States | Rocky Mountain Ear Center | Englewood | Colorado |
| United States | Michigan Ear Institute | Farmington Hills | Michigan |
| United States | University of Iowa | Iowa City | Iowa |
| United States | Midwest Ear Institute | Kansas City | Missouri |
| United States | University of Miami | Miami | Florida |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | NorthShore University Health System | Northbrook | Illinois |
| United States | Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Arizona Ear Center | Phoenix | Arizona |
| United States | Pittsburgh Ear Associates | Pittsburgh | Pennsylvania |
| United States | Kaiser Permanente South Sacramento | Sacramento | California |
| United States | Ear Institute of Texas | San Antonio | Texas |
| United States | Ohio Ear Institute | Westerville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Cochlear |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Number of Device or Procedure Related Adverse Events | Up to 5 years post-activation of the device | ||
| Secondary | 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 |