| Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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| Device | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT |
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| Generic Name | Implant, cochlear |
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| Applicant | Cochlear Americas
10350 Park Meadows Drive
Lone Tree, CO 80124 |
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| PMA Number | P890027 |
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| Supplement Number | S029 |
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| Date Received | 11/24/1995 |
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| Decision Date | 03/26/1996 |
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| Product Code |
MCM |
| Advisory Committee |
Ear Nose & Throat |
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| Supplement Type | Normal 180 Day Track |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR 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 CONSTANT 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 DURIG THE MANUFACTURING PROCESS. 13) THE USER INSTRUCITON MANUAL WILL BE REVISED |
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