Transitioning from Baha Connect to Osia System in adults with mixed or conductive hearing loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an interventional study evaluating the Osia System in adults with mixed or conductive hearing loss who already have a Baha implant with an abutment. Participants will receive the Osia System and undergo speech-perception testing in quiet and noisy settings, along with patient-reported questionnaires to assess satisfaction and quality of life. The study compares safety and performance of the Osia System to the participant’s prior Baha Connect experience. Eligibility includes adults with stable bone conduction thresholds and at least six months of Baha use, who are dissatisfied with their current device for medical reasons. Data from this study will help determine whether transitioning to Osia offers clinical advantages for this population.

Why it matters

Who can join: the full rules

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 immediate families; immediate family is defined as a spouse, parent, child, or sibling
* Cochlear employees or employees of Contract Research Organizations or contractors engaged by Cochlear for the purposes of this investigation
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless Cochlear sponsored and determined by the investigator or Sponsor to not impact this investigation)

Where it's running

• Royal National Ear, Nose and Throat and Eastman Dental Hospitals
  London, United Kingdom Recruiting
• Sheffield Teaching Hospitals
  Sheffield, United Kingdom Recruiting
• Nottingham Auditory Implant Programme
  Nottingham, United Kingdom Not yet recruiting

Study contacts

• Study coordinator: PRS Specialist
• Email: cltd-prs-admin@cochlear.com
• Phone: +61 2 9428 6555

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.