N/A
Completed N=52
Hybrid L24 New Enrollment Post Approval Study
High Frequency Sensorineural Hearing Loss
Source: ClinicalTrials.gov NCT02379819 ↗
Enrolled (actual)
52
Serious AEs
1.9%
Results posted
Mar 2023
Primary outcomePrimary: Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device — 31.3; 35.2; 35.8; 35.3 percentage of correct words
Summary
This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Consonant-Nucleus-Consonant (CNC) Word Recognition in Quiet for the Two Listening Conditions: Implant Ear Alone and When Using Both Ears Together From Pre-operatively Through 3 Years Post-activation of the Device |
31.3; 35.2; 35.8; 35.3; 36.8; 26.8 | — |
| PRIMARY Number of Device or Procedure Related Adverse Events |
98; 1 | — |
| SECONDARY Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition |
18; 24.4; 21.5; 23.7; 17.8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02379819). 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. Informational only — not medical advice.