Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System

Launched by COCHLEAR · May 14, 2008

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• 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.