Journal article
Audiological outcomes of the Cochlear Osia 2 bone conduction system implanted under expanded indications in a pediatric population
International journal of audiology
09/04/2025
DOI: 10.1080/14992027.2025.2550530
PMID: 40906592
Abstract
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.
Details
- Title: Subtitle
- Audiological outcomes of the Cochlear Osia 2 bone conduction system implanted under expanded indications in a pediatric population
- Creators
- Viral D Tejani - University Hospitals of ClevelandShawn Stevens - Barrow Neurological InstituteAbby Meyer - Children's MinnesotaMegan Bartoshuk - Lucile Packard Children's HospitalStephanie Berry - Texas Children's HospitalPage Aubuchon - Rady Children's Hospital-San DiegoMarine Cismas - Barrow Neurological InstituteShannon Doolittle - Rady Children's Hospital-San DiegoJennifer Drob - Texas Children's HospitalNancy Flores - Barrow Neurological InstituteLindsay M Hill - Children's MinnesotaErin M Levy - Rady Children's Hospital-San DiegoHannah Litton - Rady Children's Hospital-San DiegoRebecca Maher - Children's MinnesotaAmanda Marchegiani - Children's Hospital of PhiladelphiaLaurie Mauro - Children's Hospital of PhiladelphiaCatherine Moyer - Rady Children's Hospital-San DiegoJessica L S Novak - Children's MinnesotaJulie Purdy - Rady Children's Hospital-San DiegoMelissa Tribble - Lucile Packard Children's HospitalGail Murray - Case Western Reserve University
- Resource Type
- Journal article
- Publication Details
- International journal of audiology
- DOI
- 10.1080/14992027.2025.2550530
- PMID
- 40906592
- NLM abbreviation
- Int J Audiol
- ISSN
- 1708-8186
- eISSN
- 1708-8186
- Publisher
- Taylor & Francis
- Language
- English
- Electronic publication date
- 09/04/2025
- Academic Unit
- Otolaryngology
- Record Identifier
- 9984958604402771
Metrics
12 Record Views