Evaluation of New Fitting Characteristics for Extended Wear Hearing Aid Technology- Trial to Success Rate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Trial to Success Rate
研究概览
简要总结
Two groups of hearing aid candidates will be fit with extended wear technology. One group will be fit with the commercially available models, and the other group will be fit with either the commercially available model or a new model with different fitting characteristic.
After an appropriate trial period, the success rate of each group will be determined by the desire to purchase devices.
详细描述
Hearing aid candidates will be assigned to either Group A or Group B. Group A will be fit only with extended wear devices that are commercially available. Group B will be fit with either the commercially available devices, or a set of devices that have a new fitting characteristic, depending on what is most appropriate and the best fit. Because extended wear devices are inserted by a hearing care professional and sit deep within the ear canal, participants will be blinded as to which devices they are wearing. After a typical hearing aid trial period (i.e. 30 days), participants will be asked to make a determination on whether they would purchase if given the option. The percentage of people that indicate a desire to purchase devices from Group A will be compared to the percentage of people that indicate a desire to purchase devices from Group B to determine if the offering of additional fitting options results in an increase in intent to purchase, or a trial to success rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not know which device they are wearing as these devices are placed deep in the ear canal by a licensed hearing care professional. The devices are designed to stay in the ear 24 hours a day, and can be worn for several weeks or months at a time.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mild to moderate hearing loss
- •New hearing aid users with no previous hearing aid experience interested in trying Lyric devices
- •Must meet Lyric candidacy (see
排除标准
- •Exclusion Criteria:
- •middle ear disease, including but not limited to history of tympanic membrane perforations, chronic otitis media, cholesteatoma, PE tubes
- •radiation therapy to head or neck area
- •participants who need regular MRI testing
- •participants who regularly scuba dive or swim underwater
研究组 & 干预措施
Group A
Participants will be fit with commercially available Lyric devices, which range from size XXS to XXL.
干预措施: Lyric Hearing Aid- Commercially Available (Device)
Group B
Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
干预措施: Lyric Hearing Aid- Experimental Design (Device)
Group B
Participants will be fit either with the commercially available Lyric devices OR devices which are designed with a new fitting characteristic. This increases the pool of sizes from which the hearing care professional can choose to fit participant.
干预措施: Lyric Hearing Aid- Commercially Available (Device)
结局指标
主要结局
Trial to Success Rate
时间窗: Day 30 of study
Percentage of participants who express intent to purchase devices at end of study trial period. No statistical analysis was performed on this outcome measure.
次要结局
未报告次要终点