CompletedNot Applicable

Hybrid L24 New Enrollment Post Approval Study

United States52 participantsStarted 2015-02

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From pre-operatively through 3 years post-activation of the device

Number of Device or Procedure Related Adverse Events

Timeframe: Up to 5 years post-activation of the device

Trial details

NCT IDNCT02379819

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-14

Results submitted2023-02-07

View on ClinicalTrials.gov More High Frequency Sensorineural Hearing Loss trials