MedTrace Logo

Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients

NCT07130136 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-11

No results posted yet for this study

Summary

The goal of this interventional study is to confirm the safety and performance of the latest generation Osia System and to examine its benefits compared to the Baha Connect System in adults with mixed or conductive hearing loss who have a pre-existing Baha implant and Abutment (BIA300) and are transitioning to the Osia System.

The main questions this study aims to answer are:

* Is the safety and performance of the Osia System confirmed by study findings?
* What are the benefits of the Osia System compared to the Baha Connect System?

Participants will:

* Undergo speech performance testing in both quiet and noisy environments
* Provide ratings for various questionnaires

Conditions

  • Bone Conduction
  • Hearing Loss, Conductive
  • Hearing Loss, Mixed

Interventions

DEVICE

Cochlear™ Osia® System

The Osia System consists of the OSI300 Implant, Osia 2 Sound Processor, Osia 2 Sound Processor Magnets, Osia 2 Sound Processor Magnet Tool, Osia Fitting Software 2 (OFS 2), and Osia Smart App.

DEVICE

Cochlear™ Baha® System

The Baha Connect System consists of the BIA300 (BI300 Implant and BA300 Abutment), Baha 7 Sound Processor, and Baha Fitting Software 7 (BFS 7).

Sponsors & Collaborators

  • TFS HealthScience

    collaborator UNKNOWN

  • Cochlear

    lead INDUSTRY

Principal Investigators

  • PRS Specialist · Cochlear Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-11-30
Completion
2028-12-31

Countries

  • United Kingdom

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 NCT07130136 on ClinicalTrials.gov