Not yet recruitingNAINTERVENTIONAL

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

This study aims to understand how safe and effective a newer hearing device, the Osia System, is for adults. Participants in this study already have an older device called the Baha Connect System. Researchers want to see if switching to the Osia System helps people with certain types of hearing loss hear better. They will compare how well people hear speech in both quiet and noisy places after using the new device. Participants will also answer questions about their experiences. The main goal is to confirm the new system's benefits and how it compares to the older one.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Cochlear

Enrolment target

Start

01 Jul 2026

Estimated completion

01 Dec 2028

Bone Conduction Hearing Loss, Conductive Hearing Loss, Mixed

What is this study about?

This research study is looking into a new type of hearing device called the Osia System. It's designed for people who have hearing loss caused by problems with how sound travels to their inner ear. This can be either 'conductive' hearing loss (where sound can't reach the inner ear well) or 'mixed' hearing loss (a combination of conductive and nerve-related hearing loss).

The study specifically focuses on adults who already have a different hearing device called the Baha Connect System. Some people might find that their current Baha Connect System isn't working as well as they'd like, perhaps due to skin irritation or other issues. This study aims to see if changing to the newer Osia System would be a good option for them. Researchers want to make sure the Osia System is safe and performs well, and they'll compare it directly to the Baha Connect System to see if it offers better hearing and comfort.

To do this, participants will have specific tests to measure how well they hear speech in different environments, including places with background noise. They will also fill out questionnaires to share their experiences and how they feel about their hearing with the new device. The findings will help doctors understand the benefits of the Osia System for people considering this change.

Key takeaways

This study evaluates a newer hearing device called the Osia System.
It's for adults who currently use the Baha Connect System.
The goal is to check if the Osia System is safe and improves hearing.
Participants will do hearing tests and answer questionnaires.
It could offer better hearing or comfort for those dissatisfied with their current device.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must already have a specific type of Baha hearing implant, called the Baha BI300 Implant with a BA300 Abutment (also known as the Baha Connect System). You should have had your Baha Connect System for at least six months and have mixed or conductive hearing loss in the ear where it's implanted. Your hearing levels for bone conduction, measured by a pure tone average, should be 55 dB HL or less.

Your doctor needs to feel that you're not fully happy with your current Baha Connect system, perhaps due to ongoing skin problems, and that you would likely benefit from switching to the Osia System. You must also be able to speak the language used for the hearing tests fluently and be willing to give your written permission to take part. Researchers will also need to look at your medical records from when you first received your Baha Connect System.

You cannot join if you have hearing loss only in one ear and good hearing in the other (single-sided deafness with certain hearing levels in the good ear). You also can't participate if you have an active infection around your implant or if you've recently taken part in another study involving a drug or medical device (unless approved by the study team). If you or an immediate family member works for Cochlear or is directly involved with this study, you won't be able to join.

Quick self-check

Are you 18 years or older?
Do you have a Cochlear Baha BI300 Implant with a BA300 Abutment (Baha Connect)?
Have you had your Baha Connect System for at least 6 months?
Do you have mixed or conductive hearing loss in your implanted ear?
Are you able to speak the language used in the hearing tests clearly?
Is your doctor suggesting that switching to the Osia System might help you?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will undergo speech hearing tests. These tests will check how well you hear words in both quiet settings and in environments with background noise. You will also be asked to complete various questionnaires. These questionnaires will gather information about your hearing experience and how you feel about your device. The study aims to look at your experiences with both your current Baha Connect System and after you transition to the Osia System. The exact number of visits and the total length of your participation will be discussed with you by the study team.

Potential risks and benefits

Taking part in this study could offer the benefit of potentially experiencing improved hearing performance and comfort with the newer Osia System, especially if you're not fully satisfied with your current Baha Connect System. However, as with any medical procedure or device, there are potential risks, which your doctor will explain to you. These might include risks associated with any changes to your implant or potential discomfort. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Royal National Ear, Nose and Throat and Eastman Dental Hospitals
London, United Kingdom
Nottingham Auditory Implant Programme
Nottingham, United Kingdom
Sheffield Teaching Hospitals
Sheffield, United Kingdom

Common questions

What is the Osia System?

The Osia System is a newer type of hearing device for people with certain kinds of hearing loss, often used when sound doesn't travel well to the inner ear.

What is the Baha Connect System?

The Baha Connect System is an older type of hearing device that also helps people with hearing loss by sending sound through the bone directly to the inner ear.

Why is this study being done?

The study aims to see if the newer Osia System is safe and works better than the Baha Connect System for adults who already use the older device.

Will I have to have an operation?

The study is for people who already have a bone conduction implant. Any transition to a new system would involve a medical procedure, which the study team will discuss in detail.

What kind of hearing loss is this for?

This study is for people with 'conductive' hearing loss (sound struggling to reach the inner ear) or 'mixed' hearing loss (a combination of conductive and nerve-related hearing loss).

How to find out more

PRS Specialist

cltd-prs-admin@cochlear.com +61 2 9428 6555 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.