Implant, Cochlear
Basic Information
- Device Name
- Implant, Cochlear
- Trade Name
- NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM
- PMA Number
- P840024
- Supplement Number
- S060
- Device Class
- FDA Class 3
- Product Code
- MCM
- Generic Name
- Implant, cochlear
- Medical Specialty
- Unknown
- Advisory Committee
- Ear, Nose, Throat
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 26, 1996
- Date Received
- November 24, 1995
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL TO MAKE THE FOLLOWING CHANGES TO THE SPECTRA 22 SPEECH PROCESSOR:1)THE PRINTED CIRCUIT BOARD WILL BE REDESIGNED FROM A MULTI-LAYER BOARD CONFIGURATION TO A SINGLE-LAYER BOARD CONFIGURATION. 2)AN AUDIO MIXING FUNCTION, CALLED THE AUTOSWITCHING AUDIO CIRCUIT, WILL BE INCLUDED. 3) THE CLOCK OSCILLATOR FREQUENCY WILL BE CHANGED FROM A NOMINAL 5 MHZ TO 5.011 MHZ. 4)COMPONENTS WILL BE ADDED TO GIVE FURTHER PROTECTION FROM ELECTROSTATIC DISCHARGE (ESD). 5)THE EAR-LEVEL MICROPHONE POWER SUPPLY WILL BE CHANGED TO A COSTANT CURRENT SOURCE. 6)THE EXTERNAL INPUT SOCKET WILL BE REPLACED WITH AMORE ROBUST TYPE. 7)THE PATIENT SWITCH POSITIONS WILL BE CHANGED TO PUT THE "NORMAL" SENSITIVITY SELECTION FIRST. 8)A LONGER-LIFE BATTERY WILL BE PROVIDED. 9)A RESISTOR WILL BE INSERTED IN SERIES TO PROTECT THE BACK-UP BATTERY FROM EXCESSIVE CURRENT. 10)THERE WILL BE A VERSION OF THE SPECTRA 22 SPEECH PROCESSOR WHICH PROVIDES INCREASED TRANSMITTER POWER. 11)SOME MANUFACTURING TEST PARAMETERS WILL BE SLIGHTLY MODIFIED. 12)FOUR TESTS WILL BE ADDED DURING THE MANUFACTURING PROCESS. 13)THE USER INSTRUCTION MANUAL WILL BE REVISED
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MCM | Implant, Cochlear | FDA class 3 | Unknown |