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 range18 Years

SexALL

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

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