Hybrid L24 New Enrollment Post Approval Study

Nucleus Hybrid L24 Implant System: New Enrollment Study

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

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