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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameNUCLEUS HYBRID L24 IMPLANT SYSTEM
Classification Namehybrid cochlear implant
ApplicantCOCHLEAR AMERICAS
PMA NumberP130016
Date Received06/03/2013
Decision Date03/20/2014
Product Code
PGQ[ Registered Establishments with PGQ ]
Docket Number 14M-0327
Notice Date 04/10/2014
Advisory Committee Ear Nose & Throat
Clinical Trials NCT00678899
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the nucleus® hybrid l24 cochlear implant system. The nucleus® hybrid l24 cochlear implant system is intended to provide electric stimulation to the mid-to-high frequency region of the cochlea and acoustic amplification to the low frequency regions, for patients with residual low frequency hearing sensitivity. The system is indicated for unilateral use in patients aged 18 years and older who have residual low-frequency hearing sensitivity and severe to profound high frequency sensorineural hearing loss, and who obtain limited benefit from appropriately fit bilateral hearing aids. Typical preoperative hearing of candidates ranges from normal to moderate hearing loss in the low frequencies (thresholds no poorer than 60 db 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 >=75 db hl) in the ear to be implanted, and moderately severe to profound mid to high frequency hearing loss (threshold average of 2000, 3000, and 4000 hz >=60 db 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 preoperative 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 fit with hearing aids.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S006 
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