2016 Mid-Year Cochlear Implant Reliability Report 2016 Mid ... · company that performs a comprehensive failure analysis on every device explanted and in the Failure Analysis Report

2016 Mid-Year Cochlear Implant Reliability Report

Advanced Bionics AGLaubisrütistrasse 28, 8712 Stäfa, Switzerland

T: +41.58.928.78.00F: +41.58.928.78.90

[email protected]

Advanced Bionics LLC28515 Westinghouse Place

Valencia, CA 91355, United StatesT: +1.877.829.0026T: +1.661.362.1400F: +1.661.362.1500

[email protected]

A Sonova brand

For information on additional AB locations, please visitAdvancedBionics.com/contact


A Sonova brand


Your Life. Our Commitment.™

Our Mission

At Advanced Bionics we are dedicated to improving lives by developing technologies and services that help our

recipients achieve their full potential.

Our commitment to putting patients first and providing the best possible hearing performance remains at the

forefront of all that we do.

The trust patients place in us inspires us to act with integrity and transparency as we strive for excellence each

and every day in all that we do.

The Industry’s Most Transparent Reporting

As part of our commitment to providing clear and accurate information, Advanced Bionics reports all

device failures in adherence to the global standard as defined by ISO 5841-2:20141 and the principles

outlined in the European & Global Consensus on Cochlear Implant Failures and Explantations2.

Even though all manufacturers adhere to these standards, other manufacturers may report using different

definitions of what constitutes a device failure, and therefore not include the same types of information in

their reliability statistics.

Additionally, AB provides data for different iterations of implants in a series both “pre” and “post” modification,

while other manufacturers may only present their data “post” modification, leaving out important information

for the earlier, pre-modification version.

Advanced Bionics is committed to providing patients and professionals with the most complete reports, in an

easy-to-interpret format, with data presented clearly and transparently.

2


Important Tips for Reading the Graphs in this Report

80.00%

82.00%

84.00%

86.00%

88.00%

90.00%

92.00%

94.00%

96.00%

98.00%

100.00%

CSR

YEARS

Adults

Combined

Children

Adults

Combined

Children

99.94%

1

99.88%

99.82%

99.92%

2

99.73%

99.56%

99.90%

3

99.57%

99.29%

99.84%

4

99.41%

99.03%

99.78%

5

99.23%

98.72%

99.68%

6

99.09%

98.55%

99.66%

7

99.02%

98.41%

99.64%

8

98.88%

98.13%

99.57%

9

98.82%

98.08%

99.42%

10

98.53%

99.20%

11

98.42%

97.63%

HiRes 90K™ Vendor A Post Mod CSR

Graph title shows the implant name and any additional identifying

information.

CSR values are plotted with a marker for each year. Adults, children, and the combined data are plotted separately.

The black bars on each data point are confidence intervals.

These are displayed to indicate the accuracy of

statistical calculations.

What does CSR mean?Cumulative survival rate (CSR) shows

the percentage of implants that are still functional after the time in years indicated

in the table and on the graph.You may also see this described as Cumulative Survival Percentage.

Detailed CSR percentages are shown for each year in the

table. Results are broken up into adults, children, and shown

as a combined total.

3


Reporting Principle Advanced Bionics Commitment

Report all device failures in adherence to the global standard as defined by ISO 5841-2:20141. þ

Report to the seven principles of best practice reporting as outlined in the European & Global Consensus on Cochlear Implant Failures and Explantations2.

þ

AB provides this for you while others may not

Sample size and time period are specified for each reported implant.

þ


AB reports on specific device information (for example, HiRes 90K Vendor A and Vendor B devices) and will continue to do so.

þ


Reports show separate data for adults and children.

þ


95% confidence intervals are clearly and visually indicated for every graph.

þ


All failures are counted that occur any time after wound closure. þ

Actual CSR values3 presented for all implants, all generations, no computer-generated modeling data are used.

þ


Know the Truth, Understand the TransparencyAt Advanced Bionics we strive to not only provide reliable implants, but we also provide clear, complete reporting, and respond to any issues that may arise quickly, with transparency, and with the patient’s best interest in mind.

4


Know AB, Know the Difference

We strongly believe that hearing healthcare professionals,

recipients, and cochlear implant candidates should be aware

of the important differences in reporting, as the consensus

statement can allow for variability between manufacturers. CSR

can only be effectively used to compare implants when data

is provided by all manufacturers following the same reporting

principles.

In addition to providing complete CSR data, AB is the only

company that performs a comprehensive failure analysis on

every device explanted and in the Failure Analysis Report

provided to the center clearly indicate the root cause of the

failure and whether the device is counted against the CSR.

Have Questions? Need More Information? Contact Us.

AB steadfastly supports hearing healthcare professionals in their evaluation of clinical benefit provided by a device.

Company representatives remain readily available for questions, troubleshooting assistance, and device testing for

both recipients and professionals. Contact AB by calling 866.844.4327, emailing [email protected], or visiting

AdvancedBionics.com.

.

Jessica Parekh, AB Recipient

Reliability is important.

When choosing a cochlear implant you want to make sure that your device is reliable and will stand

up to your active lifestyle. At AB, reliability is the priority in everything

we do. At two years the HiRes 90K™ Advantage implant has a

99.79% CSR.

At AB our consistent innovation and cutting-edge technology

reinforces our commitment to you.

Choose AB and we promise to grow with you, providing new technology,

industry-leading advancements, and continued reliability and

transparency.

5


Introducing the New HiRes™ Ultra Cochlear Implant

The HiRes Ultra is our latest implant based on the advanced sound processing circuitry found in the HiRes 90K™

Advantage cochlear implant, now featured in a thin and discreet implant package with greater MRI compatibility.

We will begin reporting on this device once we have a sufficiently large implanted population.

6


Previous-Generation Implant Data

Scott Moulton, AB Recipient

7


HiRes 90K™ Advantage Implantthe industry’s most reliable implant

The HiRes 90K™ Advantage implant features the most advanced sound processing circuitry in the world. The sophisticated

design of all implants in the HiRes 90K family provides unsurpassed programming flexibility, nearly unlimited ways to

deliver sound, and full upgradeability for access to tomorrow’s innovations without surgery.

HiRes 90K Advantage Implant Reliability

The HiRes 90K implant from Advanced Bionics remains the most durable in

the industry. The data below indicates the real-world reliability from HiRes 90K

recipients across the globe.

Adults Children Combined

9,792 8,715 19,150*

Number of registered HiRes 90K Advantage implants as of July 1, 2016

Date of first commercial introduction: 2012This is AB’s latest implant4

99.79% reliable at

2 years

92.00%

91.00%

90.00%

93.00%

94.00%

95.00%

96.00%

97.00%

98.00%

99.00%

100.00%

CSR

AdultsCombinedChildren

99.93%1

99.84%99.73%

99.91%3

99.65%99.30%

99.91%2

99.79%99.63%

HiRes 90K™ Advantage CSR %

YEARS

Adults

Combined

Children

8


Dedicated to putting patients first, AB’s rigorous and responsive Quality Assurance System is designed to protect recipients

by ensuring exceptionally high product reliability, swiftly identifying any potential issue, and by employing appropriate

corrective actions. AB has consistently demonstrated an unparalleled commitment to recipients by taking firm and

decisive action when issues have arisen.

HiRes 90K Implant Reliability

The HiRes 90K™ implant is the most durable device on the market

when it comes to impact trauma. This means you or your child

can partake in sports and activities with the confidence that your

implant will stand up to the challenge of your active lifestyle.


25,277 30,087 56,583*

Number of registered HiRes 90K (Vendor A Post Mod) implants as of July 1, 2016

Last year of distribution4: Still available in select markets

Our stringent quality system allows AB to react quickly and with the recipient’s best interest in mind.

80.00%

82.00%

84.00%

86.00%

88.00%

90.00%

92.00%

94.00%

96.00%

98.00%

100.00%

CSR

YEARS

Adults

Combined

Children

Adults

Combined

Children

99.94%

1

99.88%

99.82%

99.92%

2

99.73%

99.56%

99.90%

3

99.57%

99.29%

99.84%

4

99.41%

99.03%

99.78%

5

99.23%

98.72%

99.68%

6

99.09%

98.55%

99.66%

7

99.02%

98.41%

99.64%

8

98.88%

98.13%

99.57%

9

98.82%

98.08%

99.42%

10

98.53%

99.20%

11

98.42%

97.63%

HiRes 90K™ Vendor A Post Mod CSR

9


Superior Quality System

Dedicated to putting patients first, AB’s rigorous and responsive Quality Assurance

System is designed to protect recipients by ensuring exceptionally high product reliability,

swiftly identifying any potential issue, and by employing appropriate corrective actions.

AB has consistently demonstrated an unparalleled commitment to recipients

by taking firm and decisive action when issues have arisen. As a result of this

incomparable commitment to recipients and a superior quality system, AB instituted

a voluntary recall in November 2010 after becoming aware of a rare issue with

the HiRes 90K cochlear implant. AB initiated the recall with only two devices out of

28,000 confirmed to have this issue. AB continues to track this data and out of more

than 50,000 implants, there are still only two confirmed instances of this issue.


26,720 31,177 59,135*

Number of registered HiRes 90K (Vendor A All) implants as of July 1, 2016

Last year of distribution4: Still available in select markets

HiRes 90K Vendor A – All CSR %

Hristo Prodanov

80.00%

82.00%

84.00%

86.00%

88.00%

90.00%

92.00%

94.00%

96.00%

98.00%

100.00%

CSR

HiRes 90K™ Vendor A - All CSR %

YEARS

Adults

Combined

Children


99.92%1

99.86%99.81%

99.88%2

99.70%99.54%

99.84%3

99.53%99.26%

99.74%4

99.33%98.97%

99.67%5

99.14%98.64%

99.54%6

98.97%98.43%

99.51%7

98.87%98.24%

99.40%8

98.63%97.86%

99.20%9

98.44%97.68%

98.99%10

98.16%97.30%

98.61%11

97.81%97.04%

98.35%12

97.35%96.28%

10


HiRes 90K Vendor A Pre Mod CSR %


1,443 1,090 2,552*

Number of registered HiRes 90K (Vendor A Pre Mod) implants as of July 1, 2016

Last year of distribution4: 2010

Advanced Bionics provides industry-leading implants

that are built to last, providing recipients with a robust solution

for hearing in any environment, anywhere.

Siobhan Davis, AB Recipient

80.00%

82.00%

84.00%

86.00%

88.00%

90.00%

92.00%

94.00%

96.00%

98.00%

100.00%

CSR

HiRes 90K™ Vendor A Pre Mod CSR

YEARS

AdultsCombined

Children

99.58%1

99.53%

99.45%

99.23%2

99.09%

98.88%

99.02%3

98.77%

98.41%

98.45%4

98.16%

97.75%

98.31%5

97.84%

97.18%

97.95%6

97.39%

96.60%

97.81%7

97.06%

96.02%

97.23%8

96.28%

94.95%

96.58%9

95.62%

94.27%

96.29%10

95.33%

93.98%

95.85%11

94.87%

93.58%

95.58%12

94.41%

92.83%

Adults

Combined

Children

11



2,199 1,837 4,066*

Number of registered HiRes 90K (Vendor B) implants as of July 1, 2016


Putting Recipients First: Implant Voluntarily Recalled in 2006

HiRes 90K Vendor B CSR %

Edward Freeman, AB Recipient

50.00%

40.00%

60.00%

70.00%

80.00%

90.00%

100.00%

CSR

HiRes 90K™ CSR % Vendor B

YEARS


97.83%1

97.78%97.69%

91.66%2

91.39%90.99%

87.03%3

85.80%84.27%

82.82%4

81.11%78.92%

79.65%5

77.69%75.16%

77.29%6

74.91%71.82%

74.31%7

71.89%68.71%

72.27%8

69.63%66.19%

70.74%9

67.75%63.85%

69.25%10

66.13%62.05%

68.27%11

65.23%61.24%

67.32%12

64.40%60.55%

Adults

Combined

Children

12


80.00%

85.00%

90.00%

95.00%

100.00%

CSR

Clarion CII CSR %

YEARS

Adults (CII)Combined (CII)Children (CII)

99.77%1

99.37%99.61%

99.70%2

98.84%99.35%

99.60%3

98.15%99.01%

99.53%4

97.80%98.83%

99.49%5

97.45%98.67%

99.42%6

96.95%98.43%

99.39%7

96.75%98.33%

99.32%8

96.39%98.14%

99.25%9

95.99%97.94%

99.22%10

95.88%97.87%

99.11%11

95.78%97.77 %

99.11%12

95.68%97.73 %

99.08%13

95.62%97.69 %

99.08%14

95.34%97.58 %

99.08%15

95.34%97.58 %

Adults (CII)

Children (CII)

Combined (CII)

Clarion Family of Implants Reliability


2,987 2,079 5,107*

Number of registered CII implants - July 1, 2016


Advanced Bionics recipients continue to benefit from the reliability and durability of the Clarion™ Series of implants.

The CII implant represents the culmination of several generations of improvements to the ceramic injection molding

technology used in the C1.2 implants.

Did you know?

AB uses actual CSR values to provide the most accurate reporting. Other manufacturers may use a computer model instead

to report failures. Kerun Bindra, AB Recipient

13



4,289 4,132 8,476*

Number of registered C1.2 implants - July 1, 2016


Clarion 1.2 (C1.2) Implant Reliability

Scott Moulton, AB Recipient

70.00%

75.00%

80.00%

85.00%

90.00%

95.00%

100.00%

105.00%

CSR

65.00%

60.00%

Clarion C1.2 CSR %

YEARS

99.81%1

99.00%99.42%

99.55%2

97.84%98.72%

98.82%3

95.89%97.40%

97.75%4

93.61%95.75%

96.55%5

91.43%94.09%

95.66%6

89.20%92.55%

94.76%7

87.70%91.37%

93.67%8

85.86%89.93%

93.01%9

84.66%89.02%

92.23%10

83.18%87.90%

91.47%11

82.24%87.06%

90.92%12

81.57%86.46%

90.52%13

80.92%85.94%

90.11%14

80.49%85.53%

89.82%15

79.21%84.79%

89.51%16

78.41%84.26%

89.11%17

78.02%83.87%

88.84%18

77.28%83.39%

88.35%19

76.97%82.98%

88.15%20

76.97%82.88%

Adults (C1.2)Combined (C1.2)Children (C1.2)

Adults (C1.2)

Children (C1.2)

Combined (C1.2)

14


Clarion 1.0 (C1.0) Implant Reliability


315 50 369*

Number of registered C1.0 implants - July 1, 2016


As the number of children implanted with the C1.0 is well below a level required for statistical analysis, the data will

be included with the adult data and presented as a combined CSR but not presented separately. The confidence

intervals has also been set to 90% as the implanted population is low.

Hear Your Bestwith AB

AB is the companythat recipients and

professionals can trustfor the best possible

hearing performance.Emma Johnson, AB Recipient

60.00%

75.00%

70.00%

65.00%

80.00%

85.00%

90.00%

95.00%

100.00%

105.00%

CSR

Clarion C1.0 CSR %

YEARS

Adults (C1.0)

Combined (C1.0)

Adults (C1.0)Combined (C1.0)

97.78%1

98.10%97.46%

2

96.75%96.18%

3

95.66%95.54%

4

95.11%94.26%

5

94.02%93.30%

6

92.93%93.30%

7

92.93%92.66%

8

92.38%91.69%

9

91.56%91.37%

10

91.28%90.39%

11

90.45%90.39%

12

90.17%90.39%

13

89.60%89.73%

14

89.04%89.07%

15

88.48%88.40%

16

87.91%88.07%

17

87.35%88.07%

18

87.35%88.07%

19

87.35%88.07%

20

87.05%87.72%

21

86.75%

15


The innovation DNA of AB and Phonak have

combined to deliver performance technologies

that will change the way you hear.

To learn more about the unique advantages

of hearing with Advanced Bionics,

call 866.844.4327 (HEAR),

email [email protected],

or visit AdvancedBionics.com.

028-M797-02 RevB

©2016 Advanced Bionics AG and affiliates. All rights reserved.

Advanced Bionics AGLaubisrütistrasse 28, 8712 Stäfa, Switzerland

T: +41.58.928.78.00F: +41.58.928.78.90

[email protected]

Advanced Bionics LLC28515 Westinghouse Place

Valencia, CA 91355, United StatesT: +1.877.829.0026T: +1.661.362.1400F: +1.661.362.1500

[email protected]

A Sonova brand

For information on additional AB locations, please visitAdvancedBionics.com/contact

The Power of Two Working Together as One

*Implants registered without DOB information are included in Combined data but cannot be classified as Adult or Child. Implant data also includes those implants implanted during clinical trials.

1. ISO 5841-2 (2014) Implants for surgery — cardiac pacemakers. International Organization for Standardization (ISO), Geneva, Switzerland.

2. European Consensus Statement on Cochlear Implant Failures and Explantations. (2005) Otology and Neurotology, 26(6):1097-1099.

3. All CSR data contained in this report is valid as of July 1, 2016.

4. Dates provided are those for major markets covered by FDA and TÜV regulation. HiRes™ Ultra and HiRes 90K™ Advantage implants, may be pending approval in a small subset of additional regions.

The AB recipients, their family members, and friends featured in this report have not been compensated for the use of their image in this material.

Documents

2016 Mid-Year Cochlear Implant Reliability Report 2016 Mid ... · company that performs a comprehensive failure analysis on every device explanted and in the Failure Analysis Report