A Pre-Market, Multicentre, Prospective, Open-Label, Within-Subject, Non-Randomised, Interventional Study Examining Acceptability of Auditory Implant Fitting Software Technologies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cochlear
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions.
研究概览
简要总结
Auditory implant fitting software is used by hearing healthcare professionals to adjust and optimize hearing implant systems for people with hearing loss. While these software tools are carefully tested before they are released, some challenges may only become apparent when they are used in everyday clinical practice. This research study will assess how well different fitting software technologies work in real-world clinical settings. Information will be collected to better understand how clinicians use the software, identify any usability issues, and find ways to improve the user experience and software design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Recipient-Participant
- •Implanted with an auditory implant in one or both ears.
- •Aged 18 years or older.
- •Willing and able to provide written informed consent.
- •Inclusion Criteria: Clinician-Participant
- •Tertiary qualification in a hearing healthcare discipline recognised for auditory implant or hearing aid fitting
- •At least 2 months' experience working with people with hearing impairment.
- •Willingness to participate in and to comply with all requirements of the protocol.
排除标准
- •Recipient-Participant
- •Additional disabilities that would prevent participation in evaluations.
- •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 Investigator or Sponsor to not impact this investigation).
- •Exclusion Criteria: Clinician-Participant
- •1) Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
研究组 & 干预措施
Investigational Fitting Software and App (Sub A)
Investigational Fitting Software and App to be used with a commercially approved sound processor
干预措施: Investigational Software (Device)
结局指标
主要结局
To evaluate clinician task-completion ratings during clinical use of the investigational device under actual-use conditions.
时间窗: 3 months
Proportion of task-completion ratings measured on a 5-point ordinal rating scale. The scale is as follows: 1 Unable to complete, 2 Completed after using help, 3 Completed after trying an incorrect option, 4 Completed after some exploration, 5 Completed at first attempt
次要结局
未报告次要终点