The Nucleus® Hybrid™ L24 Implant System New Enrollment Study
Posted Date: Nov 2, 2021
- Investigator: Ravi Samy
- Type of Study: Device
The purpose of the Nucleus Hybrid L24 Implant System: New Enrollment Study is to gather long term safety and effectiveness data on the approved device. This real world experience may allow further learning about sub-groups of patients, evaluate training programs, and further explore the type and frequency of adverse events in a long term format.
The Nucleus Hybrid L24 Implant System Is Indicated For Unilateral Use In Patients Aged 18 Years And Older Who Have Residual Low Frequency Hearing Sensitivity And Severe To Profound Highfrequency Sensorineural Hearing Loss, And Who Obtain Limited Benefit From Appropriately Fit Bilateral Hearing Aids. ? Typical Pre-Operative Hearing Of Candidates Ranges From Normal To Moderate Hearing Loss In The Low Frequencies (Thresholds No Poorer Than 60Db Hl Up To And Including 500 Hz), With Severe To Profound Mid- To High-Frequency Hearing Loss (Threshold Average Of 2000, 3000, And 4000 Hz = 75Db Hl), And Moderately Severe To Profound Mid- To High Frequency Hearing Loss (Threshold Average Of 2000, 3000, And 4000 Hz = 60Db Hl) In The Contralateral Ear. ? The Cnc Word Recognition Score Will Be Between 10% And 60% Inclusively, In The Ear To Be Implanted In The Pre-Operative Aided Condition And In The Contralateral Ear Will Be Equal To Or Better Than That Of The Ear To Be Implanted But Not More Than 80% Correct. ? Prospective Candidates Should Go Through A Suitable Hearing Aid Trial, Unless Already Appropriately Fitted With Hearing Aids.
Cochlear Implant, Hearing Loss, Nucleus Hybrid L24
For More Information:
Lisa Wenstrup, Aud