Clinical Study of Released Unitron RIC (Receiver in Canal) and BTE (Behind the Ear) Hearing Aid Models
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Speech Intelligibility Test in Noise
研究概览
简要总结
The present study will confirm the clinical benefit of 2 different released hearing aid models for speech understanding (in noise). Participants with mild to severe hearing impairment will be fit binaurally with Unitron hearing aids and will perform a standardized speech discrimination test in noise with and without hearing aids.
详细描述
Each participant will be asked to wear a set of BTE and RIC hearing aids and complete the Hearing in Noise Test (HINT) aided and unaided. The investigators will be assessing their speech intelligibility in noise for each condition during the same appointment to determine the SNR50 (the Signal-to-Noise ratio necessary for a participant to recognize the speech material correctly 50 percent of the time).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18+ years) with hearing impairment (N2 - N6 hearing loss).
- •Healthy outer ear.
- •Symmetrical hearing loss.
- •Ability to answer questions and repeat sentences.
- •Informed consent as documented by signature.
- •Willingness to wear different style of hearing aids.
- •Willingness to wear a binaural fitting.
- •Willingness to wear closed domes.
- •Willingness to adhere to COVID protocols including correct mask use, completing screening for each visit
排除标准
- •Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational product).
- •Limited mobility/not able to come to scheduled visits.
- •Inability to produce reliable hearing test result.
- •Visible congenital or traumatic deformity of the outer ear.
- •History of active drainage from the ear in the previous 90 days.
- •Abnormal appearance of the eardrum and ear canal.
- •Acute or chronic dizziness.
- •Audiometric air-bone gap equal to or greater than 15 dB at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz.
- •Known psychological problems.
研究组 & 干预措施
Experimental
The same group of participants undergo the same testing conditions. Each participant is fit with the BTE and the RIC hearing aids and then complete the speech intelligibility testing - Hearing in Noise Test (HINT) - aided and unaided during one-time visit.
干预措施: Hearing aid (Device)
结局指标
主要结局
Speech Intelligibility Test in Noise
时间窗: 2 hours appointment
Sentences are presented through a speaker in front of the participant's head. Background noise is presented through other seven speakers arranged around the participant. The senteces are presented at varying levels (both louder and softer) than the fixed level of the noise. The SNR50 is the Signal-to-Noise Ratio (SNR) expressed in decibels (dB) at which the participant can repeat 50% of the words correctly. For example, an SNR50 of +3 means that the participant repeated 50% of the words back correctly when the sentences were presented at a level that was 3dB louder than the noise. Lower scores indicate better performance.
次要结局
未报告次要终点