PMA P840024S077

Device: AUDALLION BEAMFORMER
Applicant: Cochlear Americas
PMA number: P840024
Supplement: S077
Product code: MCM
Decision date: 1998-09-25
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejction of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the Audallion, enabling the device to be more user friendly.

Current openFDA PMA Record#

Device: AUDALLION BEAMFORMER
Applicant: Cochlear Americas
PMA number: P840024
Supplement: S077
Product code: MCM
Generic name: Implant, cochlear
Decision date: 1998-09-25
Decision code: APPR
Date received: 1998-09-21
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval of four minor design changes to the Audallion Beamformer Noise Reduction System: 1)switch on/off circuit improvements 2) replacement of the LC filter with an RC filter 3) battery spring design change 4) a minor software change pertaining to the volume default. With reference to item 1), the resistor value change would improve the switch on/off of the Audiallion regarding item 2), the RC filter will improve the rejction of the overall RF interference. For item 3), changing the battery spring design will ensure the proper battery contact position, reducing the likelihood of battery discharge. Item 4) pertains to a software change that will retain the user's volume setting whenever s/he cycles through the available procesor settings on the Audallion, enabling the device to be more user friendly.