Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
OSIRIS
Post-Market Clinical Follow-Up of the Osia System and Evaluation of Benefits of Transitioning From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients With Mixed or Conductive Hearing Loss
1 other identifier
interventional
20
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2026
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2025
CompletedFirst Posted
Study publicly available on registry
August 19, 2025
CompletedStudy Start
First participant enrolled
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 11, 2026
July 1, 2025
2.5 years
August 12, 2025
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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)
Speech perception in noise will be assessed using the Bamford-Kowal-Bench-Speech in Noise (BKB-SIN) test, which assesses speech recognition in the presence of background noise. This test consists of lists of sentences, each containing 3-4 key words, presented at 65 dB SPL with increasingly progressive levels of background noise. One point is awarded for each correctly repeated word, and the results are used to calculate the signal-to-noise ratio (SNR) at which 50% of the key words (SNR-50) are correctly repeated.
At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3-months post-implantation (Day 90)
Secondary Outcomes (9)
The incidence rates of Adverse Events (AEs) and Device Deficiencies (DD) (both systems)
From screening through to the end of study at 6 months (Day 180), including any additional visits (Ad Hoc)
The frequency and types of healthcare interventions related (both systems)
At Baseline Visit 1 (2-3 weeks prior to Baseline Visit 2) to study end (Day 180)
Change (within-subject) in word recognition score in quiet measured at 65 dB SPL (pre-operative unaided and post-operative aided with the Osia System)
At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)
Total score and attribute scores from the Health Utilities Index (HUI)-2/3 questionnaire (Osia System)
At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)
Global score and subscale scores from the Speech Spatial Qualities of Hearing Scale (SSQ-49) questionnaire (Osia System)
At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)
- +4 more secondary outcomes
Study Arms (1)
Cochlear™ Osia® System and Cochlear™ Baha® System
EXPERIMENTALParticipants undergoing transition from the Baha Connect System to the Osia System will complete a series of assessments and questionnaires designed to evaluate the clinical performance and user satisfaction of both systems.
Interventions
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.
The Baha Connect System consists of the BIA300 (BI300 Implant and BA300 Abutment), Baha 7 Sound Processor, and Baha Fitting Software 7 (BFS 7).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
- TFS HealthSciencecollaborator
Study Sites (3)
Royal National Ear, Nose and Throat and Eastman Dental Hospitals
London, WC1E 6DG, United Kingdom
Nottingham Auditory Implant Programme
Nottingham, NG1 5DU, United Kingdom
Sheffield Teaching Hospitals
Sheffield, S10 2JF, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
PRS Specialist
Cochlear Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2025
First Posted
August 19, 2025
Study Start
May 1, 2026
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
February 11, 2026
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share
Cochlear do not have an approved platform for public sharing of IPD collected in this study. Data may be provided to individual researchers on request.