Clinical trial NCT02379819: Hybrid L24 New Enrollment Post Approval Study
Official title: Nucleus Hybrid L24 Implant System: New Enrollment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Frequency Sensorineural Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2015-03-05
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: From pre-operatively through 3 years post-activation of the device
measure: Number of Device or Procedure Related Adverse Events
timeFrame: Up to 5 years post-activation of the device
Secondary outcomes:
measure: Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition
timeFrame: Pre-operatively, up to 3 years post-activation of the device
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Ear Center
state: Arizona
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento
state: California
city: Aurora
country: United States
facility: University of Colorado Hospitals
state: Colorado
city: Englewood
country: United States
facility: Denver Ear Associates
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Ear Center
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Northbrook
country: United States
facility: NorthShore University Health System
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: Greater Baltimore Medical Center
state: Maryland
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Ear Institute
state: Michigan
city: Kansas City
country: United States
facility: Midwest Ear Institute
state: Missouri
city: Cincinnati
country: United States
facility: The University of Cincinnati
state: Ohio
city: Westerville
country: United States
facility: Ohio Ear Institute
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pittsburgh Ear Associates
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: San Antonio
country: United States
facility: Ear Institute of Texas
state: Texas
Study officials:
affiliation: Greater Baltimore Medical Center
name: Brian Kaplan, MD
role: PRINCIPAL_INVESTIGATOR
References: