NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM
FDA premarket approval P130016 · decided 2014-03-20
Approval details
- PMA number
- P130016
- Trade name
- NUCLEUS HYBRID L24 COCHLEAR IMPLANT SYSTEM
- Generic name
- Cochlear implant with combined electrical stimulation and acoustic amplification
- Applicant
- Cochlear Americas
- Date received
- 2013-06-03
- Decision date
- 2014-03-20
- Days to decision
- 290 days
- Decision code
- APPR
- Product code
- PGQ
- Advisory committee
- Ear, Nose, Throat
- Expedited review
- Yes
- Location
- Lone Tree, CO
- 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 RESIDUALLOW-FREQUENCY HEARING SENSITIVITY AND SEVERE TO PROFOUND HIGH FREQUENCY SENSORIN
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