Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- in Situ Real-ear Aided Response (REAR)
研究概览
简要总结
The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. If the coupler-based fitting protocol tested in this study as effective as the traditional fitting protocol, then patients receiving replacement hearing aids may circumvent a face-to-face visit.
详细描述
This study will incorporate a verification technique that simulates the patient's actual ear during probe microphone verification measurements, called real-ear to coupler difference (RECD). Because the patient's ear is not used during the RECD measurement, but rather simulated, the patient would not need to be present during the RECD verification. This RECD hearing aid verification can occur in the clinic after which the hearing aids will be mailed to the patient. This study will compare the fitting accuracy and outcomes between the two approaches.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no more than a moderate sensorineural hearing loss (defined as < 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
- •experienced BTE hearing-aid users who are obtaining replacement VA-issued BTE hearing aids coupled to a custom earmold that is simply an upgrade in model with the same style earmold
- •ability to read and write in English as determined by reading a few sentences from the consent document aloud so that self-report measures can be completed
排除标准
- •outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
- •lack of phone or non-use of the phone as the participants will be required to conduct a telephone interview after they obtain their replacement hearing aids
- •unwilling or unable to be mailed hearing aids
- •co-morbid condition that would preclude their participation as determined by a chart review
研究组 & 干预措施
Standard of Care group
Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach
干预措施: standard hearing aid fitting (Behavioral)
Average RECD group
This group will have their hearing aid fitting via the coupler using average RECD values during the fitting
干预措施: coupler-based fitting (Behavioral)
Measured RECD group
This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting
干预措施: coupler-based fitting (Behavioral)
结局指标
主要结局
in Situ Real-ear Aided Response (REAR)
时间窗: at the visit where in-situ real ear measurements are made (immediate post-fitting)
Deviation from prescriptive target (re: in situ REAR) from both ears of each participant for each group. This measure reflects the accuracy of the hearing aid fittings from 250 Hz through 3000 Hz (the average bandwidth of audibility).
次要结局
- Device Oriented Subjective Outcome (DOSO) Scale(1 month post-fitting)
- Client-Oriented Scale of Improvement (COSI)(1 month post-fitting)
- Satisfaction With Amplification in Daily Life (SADL)(1 month post-fitting)