Effectiveness Comparison of 3D-Printed and Conventional Ear Tip Comfort in Individuals With Hearing Loss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 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 over a prolonged duration in a sample of individuals with bilateral hearing loss. 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
- 否
入选标准
- •Bilateral, symmetric, sensorineural hearing loss, with thresholds between normal and severe degree of hearing loss
- •Normal otoscopy: patent ear canals with normal appearing eardrums and aerated middle ear, bilaterally.
- •English speaking.
排除标准
- •Self reported history of extensive or current outer or middle ear pathology.
- •Self reported history of extensive outer or middle ear surgery.
- •Self reported history of neurological or cognitive disorder.
- •Active ear infection
研究组 & 干预措施
In-house Study group_Resin
participants will initially receive ear tips fabricated using biocompatible resin
干预措施: BTE hearing aids with compatible ear tips (Resin, Third-party, FlexRes) (Device)
Third-party Manufactured
participants will initially receive ear tips fabricated by third party manufacturer using biocompatible resin
干预措施: BTE hearing aids with compatible ear tips (Third-party, FlexResin, Resin) (Device)
In-house Study group_FlexibleResin
Participants will initially receive ear tips fabricated using biocompatible flexible resin
干预措施: BTE hearing aids with compatible ear tips (FlexResin, Resin, Third-party, FlexResin) (Device)
结局指标
主要结局
Real Ear Measures
时间窗: through study completion, an average of 1 week
Evaluation of ear canal acoustics with participant wearing a hearing aid and eartip type (3d party, in-house\_Resin, in-house\_FlexResin). 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.
Outer EAR comfort questionnaire
时间窗: through study completion, an average of 1 week
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(through study completion, an average of week)
- Time(through study completion, an average of week)
研究者
Bryan Wong
Assistant Professor of Practice
University of Arizona