International journal of audiology · 2025
Audiological outcomes of the Cochlear Osia 2 bone conduction system implanted under expanded indications in a pediatric population.
СтатьяМногоцентровое исследованиеКлиническое исследованиеНазвание и аннотация: Перевод в очереди
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Tejani Viral D, Stevens Shawn, Meyer Abby, Bartoshuk Megan, Berry Stephanie, Aubuchon Page, Cismas Marine, Doolittle Shannon, Drob Jennifer, Flores Nancy, Hill Lindsay M, Levy Erin M, Litton Hannah, Maher Rebecca, Marchegiani Amanda, Mauro Laurie, Moyer Catherine, Novak Jessica L S, Purdy Julie, Tribble Melissa, Murray Gail
Аннотация
OBJECTIVE: Evaluate the audiological outcomes of the Cochlear Osia® 2 Bone Conduction System implanted in children ages 5-11 years old.
DESIGN: A pivotal, prospective, open-label, multicentre clinical trial to expand access to the Osia 2 system to children ages 5-11 years old.
STUDY SAMPLE: Children aged 5-11 years old who presented with either (1) a conductive or mixed hearing loss where the pure tone average bone conduction threshold (measured at 500, 1000, 2000, and 3000 Hz) was ≤ 55 dB HL or (2) single-sided deafness where the ear to be implanted had a profound sensorineural hearing loss and the pure tone average air conduction threshold (measured at 500, 1000, 2000, and 3000 Hz) in the contralateral ear was ≤ 20 dB HL.
RESULTS: Significant improvements were seen for objective word recognition measures (CNC, BKB-SIN) and subjective measures (SSQ questionnaire). Average device daily wear time was 10 hours, based on parental reports. Improvements were comparable to those shown with previous bone conduction technology in adults and older children.
CONCLUSIONS: The Osia 2 Bone Conduction System provides significant improvements in audiological outcomes in children ages 5-11 years. Data from this trial led to FDA cleared age expansion in April 2024.
DESIGN: A pivotal, prospective, open-label, multicentre clinical trial to expand access to the Osia 2 system to children ages 5-11 years old.
STUDY SAMPLE: Children aged 5-11 years old who presented with either (1) a conductive or mixed hearing loss where the pure tone average bone conduction threshold (measured at 500, 1000, 2000, and 3000 Hz) was ≤ 55 dB HL or (2) single-sided deafness where the ear to be implanted had a profound sensorineural hearing loss and the pure tone average air conduction threshold (measured at 500, 1000, 2000, and 3000 Hz) in the contralateral ear was ≤ 20 dB HL.
RESULTS: Significant improvements were seen for objective word recognition measures (CNC, BKB-SIN) and subjective measures (SSQ questionnaire). Average device daily wear time was 10 hours, based on parental reports. Improvements were comparable to those shown with previous bone conduction technology in adults and older children.
CONCLUSIONS: The Osia 2 Bone Conduction System provides significant improvements in audiological outcomes in children ages 5-11 years. Data from this trial led to FDA cleared age expansion in April 2024.
Предметные рубрики MeSH
HumansChildBone ConductionChild, PreschoolProspective StudiesHearing Loss, ConductiveMaleFemaleTreatment OutcomeHearing Loss, Mixed Conductive-SensorineuralCochlear ImplantsAuditory ThresholdSpeech PerceptionCochlear ImplantationAudiometry, Pure-ToneAuditory AcuityProsthesis DesignHearing Loss, Unilateral