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Hearing Implant

Nucleus Hybrid L24 Implant for High-Frequency Hearing Loss (HNE Trial)

N/A
Waitlist Available
Led By Brian Kaplan, MD
Research Sponsored by Cochlear
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-activation of the device
Awards & highlights

HNE Trial Summary

This trial found that the Nucleus Hybrid L24 Implant was safe and effective in newly implanted adults over a period of 3 years.

Eligible Conditions
  • High-Frequency Hearing Loss

HNE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-activation of the device
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post-activation of the device for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Number of Device or Procedure Related Adverse Events
Secondary outcome measures
Change in AzBio Sentence Recognition in Noise in the Best Unilateral Condition

HNE Trial Design

1Treatment groups
Experimental Treatment
Group I: Nucleus Hybrid L24 ImplantExperimental Treatment1 Intervention
Adults age 18 and over who meet FDA criteria for unilateral implantation with the Nucleus Hybrid L24 Implant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nucleus Hybrid L24 Implant
2015
N/A
~90

Find a Location

Who is running the clinical trial?

CochlearLead Sponsor
89 Previous Clinical Trials
5,979 Total Patients Enrolled
Brian Kaplan, MDPrincipal InvestigatorGreater Baltimore Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Hybrid L24 New Enrollment Post Approval Study
2015. "Hybrid L24 New Enrollment Post Approval Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02379819.
~5 spots leftby Apr 2025
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