Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult… (NCT07130136) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
United Kingdom20 participantsStarted 2026-07
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older
* Implanted with a Cochlear Baha BI300 Implant in combination with a Cochlear Baha BA300 Abutment (Baha Connect)
* Mixed or conductive hearing loss in the ear implanted with the Baha Connect System
* Bone conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2, and 4 kHz) of ≤ 55 dB HL in the ear implanted with the Baha Connect System
* Experience of at least 6 months with the Baha Connect System
* Candidate is judged by the investigator to be dissatisfied with their current Baha Connect System due to medical issues, e.g., recurrent adverse skin reactions, and is considered likely to benefit from transitioning to an Osia System
* Candidate is a fluent speaker in the language used to assess speech perception performance
* Candidate is willing and able to provide written informed consent
* Candidate has a retrospective medical record from the time of implantation with the Baha Connect System which the investigational site is authorized to review
Exclusion Criteria:
* Candidate with single-sided deafness (air conduction thresholds with pure tone average (PTA4; mean of 0.5, 1, 2 and 3 kHz) of ≤ 20 dB HL in the good ear)
* Candidate with an acute infection (Holgers grade 4) at the implant site at the time of screening
* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
* Investigator site personnel directly affiliated with this study and/or their immedi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change (within-subject) in speech reception threshold in noise measured at 65 dB SPL (pre-operative unaided and post-operative aided with the Osia System)
Timeframe: At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3-months post-implantation (Day 90)