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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Cochlear
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- 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)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Cochlear™ Osia® System and Cochlear™ Baha® System
Participants 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.
干预措施: Cochlear™ Baha® System (Device)
Cochlear™ Osia® System and Cochlear™ Baha® System
Participants 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.
干预措施: Cochlear™ Osia® System (Device)
结局指标
主要结局
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)
时间窗: 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.
次要结局
- 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))
- 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 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))
- 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))
- 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))
- 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))