A Pre-market, Feasibility, Prospective, Open-label, Within Subject Investigation Evaluating the Clinical Performance of the Osia 3 Sound Processor Compared With the Osia 2 Sound Processor in Adult Osia Implant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cochlear
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL
研究概览
简要总结
This study aims to investigate the clinical performance of the Osia 3 Sound Processor in comparison to the Osia 2 Sound Processor in adults with mixed or conductive hearing loss or single-sided deafness implanted with an Osia implant. Participants will attend four study visits, where they will complete various hearing assessments using the Osia sound processors.
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
- •Implanted with a Cochlear Osia Implant (OSI100 or OSI200)
- •Conductive or mixed hearing loss in the implanted ear. Bone conduction threshold 4-frequency pure tone average (PTA4; mean of bone conduction thresholds at 0.5, 1, 2 and 4 kHz) ≤ 55 dB HL.
- •OR Single-Sided Deafness in the implanted ear. Air Conduction threshold 4-frequency pure tone average (PTA4; mean of air conduction thresholds at 0.5, 1, 2 and 3 kHz) ≤ 20 dB HL in the good ear.
- •Aged 18 years or older, at time of consent.
- •Minimum experience of 1 month with the Osia 2 Sound Processor.
- •Fluent speaker in the language used to assess speech perception performance.
- •Willing and able to provide written informed consent.
- •For voluntary visit Aqua+ in water only: Be comfortable with going into a swimming pool and putting head under water.
排除标准
- •Sensitivity to loud sounds.
- •Ongoing infection at or around the sound processor area.
- •Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
- •Use of ototoxic drugs that could be harmful to the hearing, as judged 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 Organisations 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 the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
研究组 & 干预措施
Cochlear™ Osia® System
Participants will receive the Osia 3 and Osia® 2 sound processors. They will then complete a series of assessments designed to evaluate the clinical performance of these two sound processors. These assessments will take place across four study visits.
干预措施: Cochlear Osia 3 Sound Processor (Device)
Cochlear™ Osia® System
Participants will receive the Osia 3 and Osia® 2 sound processors. They will then complete a series of assessments designed to evaluate the clinical performance of these two sound processors. These assessments will take place across four study visits.
干预措施: Cochlear™ Osia® 2 Sound Processor (Device)
结局指标
主要结局
Change (within subject) in speech reception threshold in noise with fixed noise level at 65 dB SPL
时间窗: During week 48-52
Speech perception in noise will be measured using the Australian Speech Test in Noise (AuSTIN), which is a test that uses Bamford-Kowal-Bench (BKB)-like target sentences presented in adaptive noise. The AuSTIN corpus comprises 80 lists of 20 sentences each, recorded in female voice. The goal of the adaptive Speech-in-Noise test is to obtain the Speech Reception Threshold in noise.
Change (within subject) in aided thresholds in sound field measured at 0.25, 0.5, 0.75, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0 and 8.0 kHz
时间窗: During week 48-52
Aided thresholds in sound field will be measured using warble tones presented from a front speaker positioned at 1 m from the subject following the modified Hughson-Westlake procedure. Frequencies to be tested are 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 Hz.
Change (within subject) in the subjective rating of different aspects of sound when listening to sound clips
时间窗: During week 48-52
After listening to different sound clips with Osia 3 and the Osia 2 sound processors, the subjects will rate specific aspects of the sound, e.g., loudness or sound quality, on a Likert scale from 1 to 5 in steps of 1. A rating of 1 is least positive while a rating of 5 is most positive. They will also be asked to explain their sound quality experience in their own words per sound clip.
Change (within subject) in the subjective rating of different aspects of sound during a walk
时间窗: During week 48-52
The investigator will hold a conversation with the participant in real-life situations while they wear the Osia 3 sound processor (sound processor only or combined with Osia 3 Aqua+) or Osia 2 sound processor. After the walk, the investigator will ask the participant to rate specific aspects of the sound they experienced on a Likert scale from 1 to 5.
Percentage of participants who preferred Osia 3 over Osia 2 sound processor
时间窗: During week 48-52
Participants will be asked which device they prefer after having listened with both devices (Osia 2 and Osia 3) to different sound clips.
次要结局
未报告次要终点