PMA P960058S094

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S094
Product code: MCM
Decision date: 2012-04-02
Classification: Implant, Cochlear
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A NEW ACCESSORY, CALLED T -COMM, FOR ADVANCED BIONICS BODY-WORN SOUND PROCESSORS. THIS ACCESSORY ALLOWS THE USE OF THE CURRENTLY-APPROVED T-MIC TO BE USED WITH THE BODY-WORN SOUND PROCESSORS. THE T-COMM ALSO INCORPORATES A TELECOIL. A SWITCH ALLOWS THE USER TO SELECT BETWEEN T-MIC, TELECOIL, OR A 50/50 MIX OF THE TWO INPUTS.

Current openFDA PMA Record#

Device: HARMONY HIRESOLUTION BIONIC EAR SYSTEM
Applicant: Advanced Bionics
PMA number: P960058
Supplement: S094
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2012-04-02
Decision code: APPR
Date received: 2011-11-02
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW ACCESSORY, CALLED T -COMM, FOR ADVANCED BIONICS BODY-WORN SOUND PROCESSORS. THIS ACCESSORY ALLOWS THE USE OF THE CURRENTLY-APPROVED T-MIC TO BE USED WITH THE BODY-WORN SOUND PROCESSORS. THE T-COMM ALSO INCORPORATES A TELECOIL. A SWITCH ALLOWS THE USER TO SELECT BETWEEN T-MIC, TELECOIL, OR A 50/50 MIX OF THE TWO INPUTS.