Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Percentage of Correct Word Responses
研究概览
简要总结
The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology. In this study, two remote microphone technologies will be evaluated to determine benefit in speech understanding in noise.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric RM Technology Group:
- •Inclusion Criteria:
- •English speaking pediatric conduction device users and their guardian/s will be included for study.
- •We will include pediatric patients 5 years of age to 17 years of age who have a conductive or mixed unilateral or bilateral hearing loss with a minimum of a 30 decibels (dB) air-bone gap.
排除标准
- •- Participants who do not meet the described inclusion criteria.
- •Normal Hearing Controls:
- •Inclusion Criteria:
- •Adults greater than18 years of age.
- •Hearing thresholds < 25 dB 500 - 4,000 Hz.
- •Exclusion Criteria:
- •- Non-English speakers.
研究组 & 干预措施
Remote Microphone (RM) Technology Group
The RM technology group will limited to the pediatrics participants.
Participants will be tested separately on the three following conditions:
- Bone Conduction Device (BAHA) only
- BAHA + Wireless Audio-Streaming Accessory
- BAHA + Digital Adaptive RM System
干预措施: BAHA (Device)
Remote Microphone (RM) Technology Group
The RM technology group will limited to the pediatrics participants.
Participants will be tested separately on the three following conditions:
- Bone Conduction Device (BAHA) only
- BAHA + Wireless Audio-Streaming Accessory
- BAHA + Digital Adaptive RM System
干预措施: Wireless Audio Streaming Accessory (Device)
Remote Microphone (RM) Technology Group
The RM technology group will limited to the pediatrics participants.
Participants will be tested separately on the three following conditions:
- Bone Conduction Device (BAHA) only
- BAHA + Wireless Audio-Streaming Accessory
- BAHA + Digital Adaptive RM System
干预措施: Digital Adaptive RM System (Device)
Normal Hearing Controls
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
- Unaided
- Unilateral hearing aid with contralateral plug.
- Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
- Bone Conduction Device (BAHA) only
- BAHA + Wireless Audio-Streaming Accessory
- BAHA + Digital Adaptive RM System
干预措施: BAHA (Device)
Normal Hearing Controls
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
- Unaided
- Unilateral hearing aid with contralateral plug.
- Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
- Bone Conduction Device (BAHA) only
- BAHA + Wireless Audio-Streaming Accessory
- BAHA + Digital Adaptive RM System
干预措施: Wireless Audio Streaming Accessory (Device)
Normal Hearing Controls
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
- Unaided
- Unilateral hearing aid with contralateral plug.
- Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
- Bone Conduction Device (BAHA) only
- BAHA + Wireless Audio-Streaming Accessory
- BAHA + Digital Adaptive RM System
干预措施: Digital Adaptive RM System (Device)
Normal Hearing Controls
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
- Unaided
- Unilateral hearing aid with contralateral plug.
- Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
- Bone Conduction Device (BAHA) only
- BAHA + Wireless Audio-Streaming Accessory
- BAHA + Digital Adaptive RM System
干预措施: Hearing Aid (Device)
结局指标
主要结局
Percentage of Correct Word Responses
时间窗: 2 hours
Percentage of correct word responses as assessed via the Pediatric AZBio Sentence List test at -10 decibels (dB) signal to noise ratio. The total score ranges from 0-100% with the higher score indicating increased listening in noise performance.
次要结局
未报告次要终点
研究者
Hillary A Snapp
Associate Professor of Clinical
University of Miami