Novel Technology Adoption in the Audiology Clinic: Investigations of Ear Tip Performance, Perceptions, and Experiences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Production Variable
研究概览
简要总结
Normal hearing participants will be fit with a hearing aid and different types of customized earmolds. Hearing aids will be programmed to a simulated mild, flat, sensorineural hearing loss of 30 dB HL from 250-8000Hz. Objective acoustic real ear measures and subjective ratings of sound quality and physical comfort will be evaluated and compared between earmolds. Findings will help researchers to better understand the impacts of different earmolds and how each might affect overall point-of-care.
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 as primary spoken language.
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
Third-party control
Ear canal impressions will be will be packaged and sent to a professional third-party manufacturer for fabrication in an acrylic material-type. These will serve as the control earmolds, by which the in-house study/intervention earmolds will be compared against. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
干预措施: BTE hearing aid with compatible earmolds (Device)
In-house Study group_Resin
Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a stereolithography 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing.To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
干预措施: BTE hearing aid with compatible earmolds (Device)
In-house Study group_PLA
Custom earmold impressions will be scanned and edited using computer-aided design software. These 3D earmold meshes will then be converted to g-code using licensed software and sent to a fused deposition modeling 3D printer for fabrication. Participants will only wear these study earmolds for the duration of testing. To control for style of earmolds, all earmolds will be made in a skeleton style with a sound bore that accommodates size #13 tubing and a separate select-a-vent (SAV).
干预措施: BTE hearing aid with compatible earmolds (Device)
结局指标
主要结局
Production Variable
时间窗: Prior to 2nd listening session appointment (15 minutes)
The total raw cost ($) for each ear mold type (3rd party\_control, in-house\_RES, and in-house\_PLA).
Real Ear Measures
时间窗: 15 minutes
Evaluation of ear canal acoustics with participant wearing a hearing aid and earmold type (3d party control, in-house\_Resin, in-house\_PLA). 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 earmold type is changed and recording is repeated until all ear mold material types have been tested for each individual. Arms/Groups were collapsed for RM-ANOVA to compare between various earmold types. A post-hoc paired t-test w/ Bonferroni correction was utilized to compare ear mold material types.
Physical Dimensions
时间窗: Prior to 2nd listening session appointment (15 minutes)
Physical dimensions of each ear mold type (3rd party Control, in-house\_Resin, in-house\_PLA) were taken using digital calipers in millimeters prior to being worn by participants.
Outer Effectiveness of Auditory Rehabilitation (EAR) Questionnaire
时间窗: 2nd listening session appointment (15 minutes)
A questionnaire eliciting patient perception of physical comfort, quality of voice, and overall self-perceived satisfaction. Includes 12 items (5 point) that are scored on a 0 to 100, with 100 representing best possible function/rating
次要结局
未报告次要终点