Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCochlear
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cochlear™ Osia® System
DeviceThe 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.
Cochlear™ Baha® System
DeviceThe Baha Connect System consists of the BIA300 (BI300 Implant and BA300 Abutment), Baha 7 Sound Processor, and Baha Fitting Software 7 (BFS 7).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cochlear™ Osia® System and Cochlear™ Baha® SystemExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3-months post-implantation (Day 90)Secondary outcomes
1
The incidence rates of Adverse Events (AEs) and Device Deficiencies (DD) (both systems)
The incidence rates of all reported AEs per device type and specific rates for DD will be assessed. A breakdown by category will be provided to indicate the proportion of patients experiencing each category (by severity, by relatedness to device or procedure, and by seriousness) of AE and DD.
Time frame
From screening through to the end of study at 6 months (Day 180), including any additional visits (Ad Hoc)2
The frequency and types of healthcare interventions related (both systems)
The frequency and types of healthcare interventions (e.g., follow-up visits, treatments, and hospitalisations) associated with the use of the device systems will be collected.
Time frame
At Baseline Visit 1 (2-3 weeks prior to Baseline Visit 2) to study end (Day 180)3
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)
Word recognition in quiet will be measured using the Arthur Boothroyd (AB) Speech Test, which assesses speech recognition in a quiet surrounding. The AB test involves monosyllables presented at 65 dB SPL, with scores recorded as the percentage of correctly repeated words at each presentation level.
Time frame
At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)4
Total score and attribute scores from the Health Utilities Index (HUI)-2/3 questionnaire (Osia System)
The HUI-2/3 perception-based questionnaire involves a comprehensive health status and health-related quality of life, using 15 questions comprised of 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition, and Pain. A score is given that reflects overall quality of life, where 1 means perfect health and 0 means a state equivalent to death.
Time frame
At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Cochlear
Lead sponsor
TFS HealthScience
Collaborator
Source ClinicalTrials.gov