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

NCT07156461 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2026-01-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • PRS Specialist · Cochlear Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-09
Primary Completion
2025-11-24
Completion
2025-11-24
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156461 on ClinicalTrials.gov