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Audiological outcomes of the Cochlear Osia 2 bone conduction system implanted under expanded indications in a
Viral D Tejani1,2, Shawn Stevens3, Abby Meyer4
1Otolaryngology-Head and Neck Surgery, ENT Institute, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.
Insights
The Cochlear Osia® 2 Bone Conduction System significantly improved hearing in children aged 5-11. This pediatric hearing solution demonstrated comparable results to previous bone conduction technologies, leading to FDA clearance.
Area of Science:
- Audiology
- Biomedical Engineering
- Pediatric Otolaryngology
Background:
- Conductive, mixed, or single-sided deafness in children requires effective hearing solutions.
- Bone conduction systems offer an alternative for individuals with specific hearing loss types.
- Expanding access to advanced hearing technology for younger pediatric populations is crucial.
Purpose of the Study:
- To evaluate the audiological outcomes of the Cochlear Osia® 2 Bone Conduction System in children aged 5-11 years.
- To assess the safety and efficacy of the Osia 2 system in a pediatric cohort.
- To support the age expansion of the Osia 2 system for younger children.
Main Methods:
- A prospective, open-label, multicentre clinical trial.
- Inclusion criteria: children aged 5-11 with conductive/mixed hearing loss (BC threshold ≤ 55 dB HL) or single-sided deafness.
- Evaluation of objective (CNC, BKB-SIN) and subjective (SSQ) audiological measures.
Main Results:
- Significant improvements observed in objective word recognition (CNC, BKB-SIN) and subjective hearing measures (SSQ).
- Average daily device wear time reported as 10 hours by parents.
- Audiological outcomes were comparable to previous bone conduction technologies in adults and older children.
Conclusions:
- The Cochlear Osia® 2 Bone Conduction System demonstrates significant audiological benefits for children aged 5-11.
- The study data contributed to the FDA's clearance for expanded use in this younger age group in April 2024.
- The Osia 2 system represents an effective audiological intervention for pediatric hearing loss.
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.
