Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025
Early Failure Risk and Long-Term Outcomes of Advanced Bionics Electrode Devices Post-Recall.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Liu Kalena, O'Brien Lauren, Campbell Dan, Chiffer Rebecca, Willcox Thomas, Hunter Jacob B
Аннотация
OBJECTIVE: To characterize the timing and likelihood of electrode failure in Advanced Bionics (AB) cochlear implants and assess long-term trends following the 2020 recall of HiRes Ultra and Ultra 3D models.
STUDY DESIGN: Retrospective cohort study.
SETTING: Single tertiary academic medical center.
METHODS: We conducted a retrospective chart review of patients who received AB HiRes Ultra or Ultra 3D cochlear AB implants between January 2014 and February 2020. Patients who experienced device failure requiring revision surgery were identified. Demographics, implant date, failure status, and time to failure were recorded. Kaplan-Meier survival analysis was used to model cumulative failure risk over time.
RESULTS: A total of 140 AB implants were placed, with 24 (17.1%) device failures identified. The median time to failure was 3.6 years (range: 0.39-6.0 years). Median follow-up was 5.2 years (range: 0.1-10.7 years). There was no significant association between failure and gender, age, race/ethnicity, or laterality. Kaplan-Meier analysis demonstrated that 95% of failures occurred within the first 5.9 years, and the failure rate decreased to 2.1% per year after 5 years.
CONCLUSION: AB cochlear implant failures primarily occur within the first 5 years postimplantation, with significantly reduced risk beyond this period. These findings support long-term device stability and can inform patient counseling, expectations, and follow-up protocols.
STUDY DESIGN: Retrospective cohort study.
SETTING: Single tertiary academic medical center.
METHODS: We conducted a retrospective chart review of patients who received AB HiRes Ultra or Ultra 3D cochlear AB implants between January 2014 and February 2020. Patients who experienced device failure requiring revision surgery were identified. Demographics, implant date, failure status, and time to failure were recorded. Kaplan-Meier survival analysis was used to model cumulative failure risk over time.
RESULTS: A total of 140 AB implants were placed, with 24 (17.1%) device failures identified. The median time to failure was 3.6 years (range: 0.39-6.0 years). Median follow-up was 5.2 years (range: 0.1-10.7 years). There was no significant association between failure and gender, age, race/ethnicity, or laterality. Kaplan-Meier analysis demonstrated that 95% of failures occurred within the first 5.9 years, and the failure rate decreased to 2.1% per year after 5 years.
CONCLUSION: AB cochlear implant failures primarily occur within the first 5 years postimplantation, with significantly reduced risk beyond this period. These findings support long-term device stability and can inform patient counseling, expectations, and follow-up protocols.