Hybrid L24 New Enrollment Post Approval Study

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    100
  • sponsor
    Cochlear
Updated on 3 March 2021

Summary

This study evaluates the long term safety and effectiveness of the Nucleus Hybrid L24 Implant in a group of newly implanted adults.

Details
Condition High Frequency Sensorineural Hearing Loss
Treatment Nucleus Hybrid L24 Implant
Clinical Study IdentifierNCT02379819
SponsorCochlear
Last Modified on3 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have High Frequency Sensorineural Hearing Loss?
Do you have any of these conditions: Do you have High Frequency Sensorineural Hearing Loss??
Do you have any of these conditions: Do you have High Frequency Sensorineural Hearing Loss??
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

non-native English speaker
unwilling to comply with the test protocol
unrealistic expectations regarding the intervention
duration of sever to profound hearing loss of 30 years or greater
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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