Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing in the Normal Range
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Real Ear Measures
研究概览
简要总结
Access to affordable and timely hearing healthcare remains a major challenge for many individuals, partly due to the high cost and long turnaround time. This study will explore whether 3D-printed ear tips perform as well as or better than standard ear tips in terms of sound quality, comfort, and fit. It will also compare how long each method takes to make and how much each costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal hearing thresholds (<25 dB HL) at octave frequencies from 250-8000Hz.
- •Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
- •English speaking.
排除标准
- •history of extensive or current outer or middle ear pathology.
- •history of extensive outer or middle ear surgery.
- •history of neurological or cognitive disorder.
研究组 & 干预措施
In-house Study group_Resin
ear tips fabricated using biocompatible resin
干预措施: BTE hearing aid with compatible earmolds (Device)
Third-party control
ear tips fabricated by third party manufacturer using biocompatible resin
干预措施: BTE hearing aid with compatible earmolds (Device)
In-house Study group_FlexibleResin
ear tips fabricated using biocompatible flexible resin
干预措施: BTE hearing aid with compatible earmolds (Device)
结局指标
主要结局
Real Ear Measures
时间窗: 2nd listening session appointment (15 minutes)
Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house\_Resin, in-house\_FlexResin). Then, a thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies. Once complete, the eartip type is changed and recording is repeated until all eartip material types have been tested for each individual.
Real Ear Measures
时间窗: 2nd listening session appointment (15 minutes)
Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party control, in-house\_Resin, in-house\_FlexResin). Then, a thin microphone tube is placed in the ear canal to measure the average amount gain (dB SPL) across various frequencies (250-8000Hz) while the participant sits in front of a speaker playing sound samples. Results are recorded in gain (dB SPL) across frequencies. Once complete, the eartip type is changed and recording is repeated until all eartip material types have been tested for each individual.
Outer EAR comfort questionnaire
时间窗: 2nd listening session appointment (10 minutes)
A validated questionnaire, Outer EAR, will be used to elicit patient perception of physical comfort, acoustic comfort, quality of voice, and overall self-perceived satisfaction. Includes 6 items (5 levels) , with 5 representing best possible function/rating.
次要结局
- Cost(Prior to second listening session appointment (15 minutes))
- Time(Prior to second listening appointment (15 minutes))
研究者
Bryan Wong
Assistant Professor of Practice
University of Arizona