For evaluating the different middle ear implant systems against each other, the MEI implantation branch of the model was cloned and the Markov states were named according to the respective devices. Individuals with mild-to-severe sensorineural hearing loss enter the model after candidacy assessment and then follow the VSB or MAXUM implantation arm of the model depending on the clinical decision. The new Markov model was populated using data from the literature. Table 33 Base case model assumptions – Assumption Comment Individuals who remain unaided are at constant risk It is unknown whether repeated treatment of experiencing a recurring pathology in the same decreases the chance of an outer ear ear. pathology to reoccur. Conservative treatment of recurring pathologies, The succesful erradication of an outer ear whether succesful or not, does not alter the quality condition may positivtely affect QOL, however of life of individuals receiving no intervention. minimum, as the pathology may reoccur. Studies demonstrate patients to stop using their device after various complications. Individuals who are successfully aided do not Unsatisfactory benefit due to decreased gain or cease to use their device. hearing loss can also be categorized as an adverse event. Surgical revision provides a full resolution of This reflects general clinical practice. adverse events. Re-implantation with a new implant ocurrs in the same ear from which a failed device is explanted This reflects general clinical practice. from. The rate of device failure and reimplantation does Differences in design and surgical application not vary significantly between partially implantable of partially implantable MEI is not large. MEI. Individuals that do not experience a device Individuals wear their device for at least six months failure try out their device for a few months before potentially deciding to stop using their before making a decision to stop using their device. device. All-cause mortality in the hearing impaired Hearing loss or implantation with a partially population is equal to that in the general population. implantable MEI does not impact mortality. D.3.3 Time horizon and outcomes used in the economic evaluation The time horizon for the economic models was 10 years. This is shorter than the time horizon proposed in the Decision Analytic Protocol; however, it is long enough for
For evaluating the different middle ear implant systems against each other, the MEI implantation branch of the model was cloned and the Markov states were named according to the respective devices. Individuals with mild-to-severe sensorineural hearing loss enter the model after candidacy assessment and then follow the VSB or MAXUM implantation arm of the model depending on the clinical decision. The new Markov model was populated using data from the literature. Table 33 – Base case model assumptions Assumption Comment Individuals who remain unaided are at constant risk of experiencing a recurring pathology in the same ear. It is unknown whether repeated treatment decreases the chance of an outer ear pathology to reoccur. Conservative treatment of recurring pathologies, whether succesful or not, does not alter the quality of life of individuals receiving no intervention. The succesful erradication of an outer ear condition may positivtely affect QOL, however minimum, as the pathology may reoccur. Individuals who are successfully aided do not cease to use their device. Studies demonstrate patients to stop using their device after various complications. Unsatisfactory benefit due to decreased gain or hearing loss can also be categorized as an adverse event. Surgical revision provides a full resolution of adverse events. This reflects general clinical practice. Re-implantation with a new implant ocurrs in the same ear from which a failed device is explanted from. This reflects general clinical practice. The rate of device failure and reimplantation does not vary significantly between partially implantable MEI. Differences in design and surgical application of partially implantable MEI is not large. Individuals wear their device for at least six months before potentially deciding to stop using their device. Individuals that do not experience a device failure try out their device for a few months before making a decision to stop using their device. All-cause mortality in the hearing impaired population is equal to that in the general population. Hearing loss or implantation with a partially implantable MEI does not impact mortality. D.3.3 Time horizon and outcomes used in the economic evaluation The time horizon for the economic models was 10 years. This is shorter than the time horizon proposed in the Decision Analytic Protocol; however, it is long enough for
1365.1-SubmissionBasedAssessmentReport.docx