PMA P940022

Device: CALRION CII BIONIC EAR SYSTEM (ADULT)
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S027
Product code: MCM
Decision date: 2002-11-06
Generic name: Implant, cochlear
Approval order statement: APPROVAL FOR A REVISION TO THE PACKAGE INSERT (DOCUMENT NUMBER 9196252-001) THAT MODIFIED THE PERCENTAGE OF PATIENTS WHO PREFERRED HIGH RESOLUTION SOUND PROCESSING TO CONVENTIONAL SOUND PROCESSING. THIS MODIFICATION IS BASED ON UPDATED DATA RECEIVED FROM PATIENTS AT THE 12-MONTH FOLLOW-UP VISIT WHICH SHOWED THAT THREE OF THE FIVE PATIENTS WHO ORIGINALLY PREFERRED THEIR CONVENTIONAL STRATEGY AT THE THREE-MONTH EXPERIMENTAL STRATEGY VISIT SWITCHED THEIR PREFERENCE TO HIRES. THUS, 48 OF 50 PATIENTS (96%) ULTIMATELY PREFERRED HIRES.

Current openFDA PMA Record#

Device: CALRION CII BIONIC EAR SYSTEM (ADULT)
Applicant: Advanced Bionics Corp.
PMA number: P940022
Supplement: S027
Product code: MCM
Generic name: Implant, cochlear
Decision date: 2002-11-06
Decision code: APPR
Date received: 2002-10-25
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A REVISION TO THE PACKAGE INSERT (DOCUMENT NUMBER 9196252-001) THAT MODIFIED THE PERCENTAGE OF PATIENTS WHO PREFERRED HIGH RESOLUTION SOUND PROCESSING TO CONVENTIONAL SOUND PROCESSING. THIS MODIFICATION IS BASED ON UPDATED DATA RECEIVED FROM PATIENTS AT THE 12-MONTH FOLLOW-UP VISIT WHICH SHOWED THAT THREE OF THE FIVE PATIENTS WHO ORIGINALLY PREFERRED THEIR CONVENTIONAL STRATEGY AT THE THREE-MONTH EXPERIMENTAL STRATEGY VISIT SWITCHED THEIR PREFERENCE TO HIRES. THUS, 48 OF 50 PATIENTS (96%) ULTIMATELY PREFERRED HIRES.