PMA P960058S049

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S049
Product code: MCM
Decision date: 2006-08-17
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A MODIFICATION TO THE SOUNDWAVE PROFESSIONAL SUITE SOFTWARE (SOUNDWAVE VERSION 1.4) WHICH IMPLEMENTS AN OPTIONAL FEATURE, KNOWN AS FIDELITY 120, AND ADDS SUPPORT FOR THE AURIA HARMONY SOUND PROCESSOR. THE SOFTWARE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE VERSION 1.4 AND IS INDICATED FOR ADULT PATIENTS AND PEDIATRIC PATIENTS AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS. HOWEVER, THE OPTIONAL SOFTWARE CAPABILITY KNOWN AS FIDELITY 120 (SPEECH ENCODING STRATEGY) IS LIMITED FOR USE IN ADULTS WITH 1) POST-LINGUAL ONSET OF SEVERE OR PROFOUND HEARING LOSS, 2) A MINIMUM OF THREE-MONTHS EXPERIENCE WITH STANDARD HIRES, AND 3) WHO HAVE THE COGNITIVE ABILITY TO CHOOSE THE SOUND PROCESSING OPTIONS.

Current openFDA PMA Record#

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S049
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2006-08-17
Decision code: APPR
Date received: 2005-12-12
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A MODIFICATION TO THE SOUNDWAVE PROFESSIONAL SUITE SOFTWARE (SOUNDWAVE VERSION 1.4) WHICH IMPLEMENTS AN OPTIONAL FEATURE, KNOWN AS FIDELITY 120, AND ADDS SUPPORT FOR THE AURIA HARMONY SOUND PROCESSOR. THE SOFTWARE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOUNDWAVE PROFESSIONAL SUITE VERSION 1.4 AND IS INDICATED FOR ADULT PATIENTS AND PEDIATRIC PATIENTS AGED 12-MONTHS THROUGH 17 YEARS, 11-MONTHS. HOWEVER, THE OPTIONAL SOFTWARE CAPABILITY KNOWN AS FIDELITY 120 (SPEECH ENCODING STRATEGY) IS LIMITED FOR USE IN ADULTS WITH 1) POST-LINGUAL ONSET OF SEVERE OR PROFOUND HEARING LOSS, 2) A MINIMUM OF THREE-MONTHS EXPERIENCE WITH STANDARD HIRES, AND 3) WHO HAVE THE COGNITIVE ABILITY TO CHOOSE THE SOUND PROCESSING OPTIONS.