Post-market Evaluation of the Transition From the Baha Connect System to the Osia System in Adult Bone Conduction Implant Recipients
- Conditions
- Bone ConductionHearing Loss, ConductiveHearing Loss, Mixed
- Registration Number
- NCT07130136
- Lead Sponsor
- Cochlear
- Brief Summary
The goal of this interventional study is to evaluate 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
- Pregnant women
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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) At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3-months post-implantation (Day 90) 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.
- Secondary Outcome Measures
Name Time Method 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) The SSQ-49 involves a self-reported hearing function and the impact of hearing treatment in daily life across a variety of listening situations. It includes 3 subcategories: Speech Hearing, Spatial Hearing, and Qualities of Hearing, with each question rated on a Likert scale from 0-10 (minimum - maximum hearing abilities).
Change (within-subject) in global Satisfaction with Amplification in Daily Life (SADL) score and subscale scores (both systems) At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90) The SADL involves a self-report inventory to quantify satisfaction with hearing aids. It consists of 15 items, a generated global satisfaction score, and 4 subscale scores (positive effect, service \& cost, negative features, and personal image). The scores range from 1 to 7, where the higher scores indicate greater satisfaction with the hearing device.
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 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.
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) 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.
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) 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.
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) 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.
Change (within-subject) in word recognition score in quiet measured at 80 dB SPL (both systems) At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90) 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 80 dB SPL, with scores recorded as the percentage of correctly repeated words at each presentation level.
Change (within-subject) in word recognition score in quiet measured at 65 dB SPL (both systems) At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90) 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.
Change (within-subject) in word recognition score in quiet measured at 50 dB SPL (both systems) At Baseline Visit 2 (2-3 weeks after Baseline Visit 1) and at 3 months post-implantation (Day 90) 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 50 dB SPL, with scores recorded as the percentage of correctly repeated words at each presentation level.
Trial Locations
- Locations (4)
Countess of Chester Hospital
🇬🇧Chester, United Kingdom
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
Countess of Chester Hospital🇬🇧Chester, United Kingdom