NCT07156461

Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients

A Pivotal, Interventional, Prospective, Multi-centre Clinical Investigation of Hearing Outcomes With the Osia 3 Sound Processor Compared to the Osia 2 Sound Processor in Adult Osia Implant Recipients With Mixed Hearing Loss, Conductive Hearing Loss or Single-Sided Deafness

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional study is to evaluate the clinical performance and sound quality of the Osia 3 Sound Processor and to demonstrate its superiority compared with the Osia 2 Sound Processor in adults with mixed hearing loss, conductive hearing loss, or single-sided deafness. The main questions this study aims to answer are: * Do the findings confirm the clinical performance of the Osia 3 Sound Processor? * Is the Osia 3 Sound Processor superior compared to the Osia 2 Sound Processor? Participants will: * Undergo speech performance testing in both quiet and noisy environments * Provide ratings for a self-reported questionnaire

Conditions

• Hearing Loss, Mixed
• Hearing Loss, Conductive
• Single-Sided Deafness
• Bone Conduction

Interventions

Type	Name	Description
DEVICE	Cochlear™ Osia® System (Osia® 2)	Consists of Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, and Osia Fitting Software 2.
DEVICE	Cochlear™ Osia® System (Osia® 3)	Consists of Osia 3 Sound Processor, Osia 3 Sound Processor Magnets, Osia 3 Charger, and Osia Fitting Software 3.

Timeline

• Start date: 2025-09-09
• Primary completion: 2025-11-24
• Completion: 2025-11-24
• First posted: 2025-09-05
• Last updated: 2026-01-08

Locations

3 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study