N/A
N=50
Evaluation of the Nucleus Hybrid™ L24 Cochlear Implant System
Sensorineural Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT00678899 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcome: Primary: Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) — 65.4 percentage of words correct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nucleus Hybrid L24 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Consonant Nucleus Consonant (CNC) Monosyllabic Word Score-Treated Ear (CO-PRIMARY) |
65.4 | — |
| PRIMARY AzBio Sentence Score in Noise - Treated Ear (Co-Primary) |
49.2 | — |
| SECONDARY Consonant Nucleus Consonant (CNC) Monosyllabic Words - Treated Ear |
96 | — |
| SECONDARY AzBio Sentence Score-Treated Ear |
89.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Eighteen years of age or older at the time of implantation.
- 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.
- 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.
- CNC word recognition score in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%.
- English spoken as a primary language.
Exclusion Criteria
- Duration of severe-to-profound hearing loss greater than 30 years.
- Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
- Medical or psychological conditions that contraindicate undergoing surgery.
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- Conductive overlay of 15 dB or greater at two or more frequencies, in the range 250 to 1000 Hz.
- Hearing loss of neural or central origin.
- Diagnosis of Auditory Neuropathy.
- Active middle-ear infection.
- 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.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations.
Data sourced from ClinicalTrials.gov (NCT00678899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.