Hard failure vs. soft failure CI24M after strong impactHard 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.
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
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
Cumulative Survival Percentage,CI24R November 2003
Cumulative Survival Percentage,CI24M November 2003
Selection criteria FDA – Broadening Indications Development of candidate selection criteria United States (Nucleus Implant Systems) Adults Children1985 FDA approval for implantation of candidates aged 18 years and older postlingually deafened profound bilateral sensorineuronal deafness no benefit from hearing aid1990 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 expectations1995 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 sentences1998 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 test2000 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
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 yrsCost (€) 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
Auditory-Verbal PhilosophyAuditory-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.
Auditory-Verbal Principles 1 – 51. Early detection and diagnosis2. Aggressive audiological management3. Appropriate amplification technology to achieve maximum benefits of learning through listening4. Favourable auditory learning environments for the acquisition of spoken language including individualized therapy5. Integrating listening into the child’s entire being so listening becomes a way of life
Auditory-Verbal Principles 6 – 106. Ongoing assessment, evaluation and prognosis of the development of audition, speech, language and cognition7. Integration and mainstreaming of the children who are deaf or hard of hearing into regular education classes to fullest extent possible8. Active participation of parents in order to improve spoken communication between the child and family members9. 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 environment10. Integration of speech, language, audition and cognition in response to the psychological, social and educational needs of the child and family