7. Hard failure vs. soft failure
CI24M after strong impact
Hard failure
• A device requires explantation due to design weakness,
manufacturing fault, external impact or electrode failure
with loss of clinical benefit.
Soft failure
• Deviation from the specification with no loss of clinical
benefit. Resolved via programming.
8. The Cochlear Reporting Standard
•“Any explantation which is assessed to be required because of loss of
clinical benefit due to the device not meeting its specifications.”
• Outright Device failures e.g. IC
• Failure due to external impact
• Failure due to fatigue caused by placement error
• Failure of array resulting in loss of clinical benefit
Cochlear implant manufacturers are not obliged by any
international certification standards to report failures
caused by external agents, such as impact to the head.
However, Cochlear believes that since the implant is in
a part of the body that is vulnerable to impact,
especially for children, there is an ethical responsibility
to report all failures resulting from impact with an
external agent
9. Cumulative Survival Percentage (CPS):
What does it mean?
100
• CSP shows the percentage of devices 80
which have functioned at a given length 60
of time after implantation. 40
20
• Ensures that clinicians can confidently 0
1 2 3 4
counsel patients on the risk of technical
failure in real-life circumstances.
• Cochlear exceeds the requirements of
ISO 5841/2
13. Selection criteria FDA – Broadening Indications
Development of candidate selection criteria United States (Nucleus Implant Systems)
Adults Children
1985 FDA approval for implantation of candidates aged
18 years and older
postlingually deafened
profound bilateral sensorineuronal deafness
no benefit from hearing aid
1990 FDA approval for implantation of candidates aged
2 years and older
profound bilateral sensorineuronal deafness
little or no benefit from hearing aid
candidate and family must be well motivated and possess
realistic expectations
1995 Include pre-and perilinguistically deafened adults
Limited benefit from hearing aids defined as 30%
or less in best aided condition on tape recorded
tests of open-set sentences
1998 Limited benefit from hearing aids defined as 40% 18 months and older
or less in best aided condition on tape recorded 3-6 months hearing aid trial
tests of open-set sentences <20% score on MLNT or LNT test
2000 Limited benefit from hearing aids defined as 60% 12 months and older
or less in best aided condition on tape recorded 3-6 months hearing aid trial
tests of open-set sentences Lack of progress in development of
auditory skills or <30% score on MLNT or LNT test,
depending on age
15. Cost effectiveness
CI before CI between CI after
age 4 ages 4 and 6 age 6
100000
Poor
value
80000 for
money
73 yrs 73 yrs 73 yrs
Cost (€)
60000
15 yrs 15 yrs 15 yrs
40000
Good
20000 value
for
money
0
0 1 2 3 4 5 60 1 2 3 4 5 6 0 1 2 3 4 5 6
QALYs gained
20. Auditory-Verbal Philosophy
Auditory-Verbal International, Inc. Position Statement
• The Auditory-Verbal philosophy is a logical and critical set of
guiding principles. These principles outline the essential
requirements needed to realize the expectation that young children
who are deaf or hard of hearing can be educated to use even
minimal amounts of amplified residual hearing.
Use of amplified residual hearing in turn permits children
who are deaf or hard of hearing to learn to listen, process
verbal language, and to speak.
21. Auditory-Verbal Principles 1 – 5
1. Early detection and diagnosis
2. Aggressive audiological management
3. Appropriate amplification technology to achieve
maximum benefits of learning through listening
4. Favourable auditory learning environments for the
acquisition of spoken language including individualized
therapy
5. Integrating listening into the child’s entire being so
listening becomes a way of life
22. Auditory-Verbal Principles 6 – 10
6. Ongoing assessment, evaluation and prognosis of the
development of audition, speech, language and cognition
7. Integration and mainstreaming of the children who are
deaf or hard of hearing into regular education classes to
fullest extent possible
8. Active participation of parents in order to improve
spoken communication between the child and family
members
9. Affirmation of parents as primary models in helping the
child learn to listen to his or her own voice, the voice of
others and the sounds of the environment
10. Integration of speech, language, audition and cognition
in response to the psychological, social and
educational needs of the child and family
