Hybrid L24 New Enrollment Post Approval Study (HNE)

Cochlear

Status: Completed

Conditions: High Frequency Sensorineural Hearing Loss

Treatments: Device: Nucleus Hybrid L24 Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT02379819

CAM-5573-HYB-PMA

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Nucleus Hybrid L24 Implant

Experimental group

Description:

Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.

Treatment:

Device: Nucleus Hybrid L24 Implant