DevicePMAs@therightstef:P960058_S000 JSON TXT

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PMA_MER

Age_blah

{"project":"Age_blah","denotations":[{"id":"T1","span":{"begin":265,"end":273},"obj":"age_category"},{"id":"T2","span":{"begin":126,"end":134},"obj":"age_category"},{"id":"T3","span":{"begin":275,"end":276},"obj":"age_start"},{"id":"T4","span":{"begin":285,"end":287},"obj":"age_end"},{"id":"T5","span":{"begin":288,"end":293},"obj":"age_end_unit"},{"id":"T6","span":{"begin":275,"end":293},"obj":"age_range"},{"id":"T7","span":{"begin":372,"end":374},"obj":"age_end"},{"id":"T8","span":{"begin":375,"end":381},"obj":"age_end_unit"}],"text":"Approval for the clarion multi-strategy cochlear implant. The device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. Clarion is indicated for the following: 1)children, 2 through 17 years of age. If x-rays demonstrate evidence of ossification, children as young as 18 months may be implanted; 2)profound, bilateral sensorineural deafness; 3)undergone or be willing to undergo a hearing aid trail with appropriately fitted hearing aids; 4)lack of benefit from appropriately fitting hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones such as a child's inconsistent response to his/her name in quiet or to environmental sounds (meaningful auditory integration scale). In older children, lack of aided benefit is defined as scoring 0% on open-set word recognition (phonetically balanced kindergarten test - word list) administered with monitored live-voice (70 db spl). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development."}

PMA_age_indications

{"project":"PMA_age_indications","denotations":[{"id":"T12","span":{"begin":126,"end":134},"obj":"age_category"},{"id":"T5","span":{"begin":265,"end":273},"obj":"age_category"},{"id":"T9","span":{"begin":275,"end":276},"obj":"age_start"},{"id":"T7","span":{"begin":275,"end":293},"obj":"age_range"},{"id":"T8","span":{"begin":285,"end":287},"obj":"age_end"},{"id":"T17","span":{"begin":288,"end":293},"obj":"age_end_unit"},{"id":"T13","span":{"begin":351,"end":359},"obj":"age_category"},{"id":"T10","span":{"begin":372,"end":374},"obj":"age_start"},{"id":"T11","span":{"begin":375,"end":381},"obj":"age_start_unit"},{"id":"T14","span":{"begin":614,"end":622},"obj":"age_category"},{"id":"T15","span":{"begin":859,"end":867},"obj":"age_category"},{"id":"T16","span":{"begin":1075,"end":1083},"obj":"age_category"}],"text":"Approval for the clarion multi-strategy cochlear implant. The device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. Clarion is indicated for the following: 1)children, 2 through 17 years of age. If x-rays demonstrate evidence of ossification, children as young as 18 months may be implanted; 2)profound, bilateral sensorineural deafness; 3)undergone or be willing to undergo a hearing aid trail with appropriately fitted hearing aids; 4)lack of benefit from appropriately fitting hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones such as a child's inconsistent response to his/her name in quiet or to environmental sounds (meaningful auditory integration scale). In older children, lack of aided benefit is defined as scoring 0% on open-set word recognition (phonetically balanced kindergarten test - word list) administered with monitored live-voice (70 db spl). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development."}

updated_tagging_age_PMA_annotations

{"project":"updated_tagging_age_PMA_annotations","denotations":[{"id":"T10","span":{"begin":372,"end":374},"obj":"age_start"},{"id":"T11","span":{"begin":375,"end":381},"obj":"age_start_unit"},{"id":"T12","span":{"begin":126,"end":134},"obj":"age_category"},{"id":"T13","span":{"begin":351,"end":359},"obj":"age_category"},{"id":"T14","span":{"begin":614,"end":622},"obj":"age_category"},{"id":"T15","span":{"begin":859,"end":867},"obj":"age_category"},{"id":"T16","span":{"begin":1075,"end":1083},"obj":"age_category"},{"id":"T17","span":{"begin":288,"end":293},"obj":"age_end_unit"},{"id":"T5","span":{"begin":265,"end":273},"obj":"age_category"},{"id":"T7","span":{"begin":275,"end":293},"obj":"age_range"},{"id":"T8","span":{"begin":285,"end":287},"obj":"age_end"},{"id":"T9","span":{"begin":275,"end":276},"obj":"age_start"}],"text":"Approval for the clarion multi-strategy cochlear implant. The device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. Clarion is indicated for the following: 1)children, 2 through 17 years of age. If x-rays demonstrate evidence of ossification, children as young as 18 months may be implanted; 2)profound, bilateral sensorineural deafness; 3)undergone or be willing to undergo a hearing aid trail with appropriately fitted hearing aids; 4)lack of benefit from appropriately fitting hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones such as a child's inconsistent response to his/her name in quiet or to environmental sounds (meaningful auditory integration scale). In older children, lack of aided benefit is defined as scoring 0% on open-set word recognition (phonetically balanced kindergarten test - word list) administered with monitored live-voice (70 db spl). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development."}

consensus_PMA_Age_Indications

{"project":"consensus_PMA_Age_Indications","denotations":[{"id":"T10","span":{"begin":372,"end":374},"obj":"age_start"},{"id":"T11","span":{"begin":375,"end":381},"obj":"age_start_unit"},{"id":"T12","span":{"begin":126,"end":134},"obj":"age_category"},{"id":"T13","span":{"begin":351,"end":359},"obj":"age_category"},{"id":"T14","span":{"begin":614,"end":622},"obj":"age_category"},{"id":"T15","span":{"begin":859,"end":867},"obj":"age_category"},{"id":"T16","span":{"begin":1075,"end":1083},"obj":"age_category"},{"id":"T17","span":{"begin":288,"end":293},"obj":"age_end_unit"},{"id":"T5","span":{"begin":265,"end":273},"obj":"age_category"},{"id":"T7","span":{"begin":275,"end":293},"obj":"age_range"},{"id":"T8","span":{"begin":285,"end":287},"obj":"age_end"},{"id":"T9","span":{"begin":275,"end":276},"obj":"age_start"}],"text":"Approval for the clarion multi-strategy cochlear implant. The device is intended to restore a level of auditory sensation to children with profound sensorineural deafness via electrical stimulation of the auditory nerve. Clarion is indicated for the following: 1)children, 2 through 17 years of age. If x-rays demonstrate evidence of ossification, children as young as 18 months may be implanted; 2)profound, bilateral sensorineural deafness; 3)undergone or be willing to undergo a hearing aid trail with appropriately fitted hearing aids; 4)lack of benefit from appropriately fitting hearing aids. In younger children, lack of benefit with hearing aids is defined as failure to attain basic auditory milestones such as a child's inconsistent response to his/her name in quiet or to environmental sounds (meaningful auditory integration scale). In older children, lack of aided benefit is defined as scoring 0% on open-set word recognition (phonetically balanced kindergarten test - word list) administered with monitored live-voice (70 db spl). Both younger and older children should demonstrate only minimal ability on age appropriate open-set sentence measures and a plateau in auditory development."}