Overview

This trial is active, not recruiting.

Condition sensorineural hearing loss
Treatment nucleus hybrid l24
Sponsor Cochlear
Start date April 2008
End date June 2012
Trial size 50 participants
Trial identifier NCT00678899, CORP5180

Summary

The purpose of this study is to evaluate the safety and efficacy associated with the provision of acoustic and electric sound processing to individuals who demonstrate significant residual low-frequency hearing and profound high-frequency (above 1500 Hz) sensorineural hearing loss. Delivery of acoustic-electric stimulation will be provided by the Nucleus Hybrid L24 cochlear implant system.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Implantation with the Nucleus Hybrid L24 Cochlear Implant
nucleus hybrid l24
Implantation with Nucleus Hybrid L24 cochlear implant

Primary Outcomes

Measure
Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY)
time frame: 6 Months Postactivation
AzBio Sentence Score in Noise - Treated Ear (Co-Primary)
time frame: 6 Months Postactivation

Secondary Outcomes

Measure
Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear
time frame: 6 Months Postactivation
AzBio Sentence Score-Treated Ear
time frame: 6 Months Postactivation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Eighteen years of age or older at the time of implantation. 2. Severe to profound (a threshold average of 2000, 3000, & 4000 Hz > 75dB HL) sensorineural hearing loss for frequencies > 1500 Hz. Low-frequency thresholds up to and including 500 Hz should be no poorer than 60 dB HL. 3. Consonant Nucleus Consonant (CNC) monosyllabic word recognition score (mean of two lists) between 10% and 60%, inclusive (i.e., 10% <= score <= 60%), in the ear to be implanted. 4. CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%. 5. English spoken as a primary language. Exclusion Criteria: 1. Duration of severe-to-profound hearing loss greater than 30 years. 2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). 3. Medical or psychological conditions that contraindicate undergoing surgery. 4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array. 5. Conductive overlay of 15 dB or greater at two or more frequencies, in the range 250 to 1000 Hz. 6. Hearing loss of neural or central origin. 7. Diagnosis of Auditory Neuropathy. 8. Active middle-ear infection. 9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices. 10. Unwillingness or inability of the candidate to comply with all investigational requirements. 11. Additional handicaps that would prevent or restrict participation in the audiological evaluations.

Additional Information

Official title Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant
Principal investigator John T Roland, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Cochlear.