A Clinical Investigation of the Benefit of Directionality as a Function of Microphone Location: BTE Hearing Aids Versus ITE Hearing Aids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bernafon AG
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Speech Intelligibility Performance
研究概览
简要总结
The current study will evaluate a new in-the-ear (ITE) hearing aid hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the behind-the-ear (BTE) hardware style with the ITE devices regarding the benefit received from different microphone locations.
详细描述
Hearing aids constantly undergo incremental improvements from already marketed devices. The new devices are expected to perform as well or better than the previous ITE devices.
The aim of the testing is to grant quality control prior to product launch according to Bernafon development requirements.
The current study will evaluate a new ITE hearing aid hardware. The firmware driving the hearing aid has already been sold on the market using the BTE hardware for almost one year and will now be launched using the ITE custom hardware. The goal is to evaluate the audiological performance, usability, feature function, and to identify unexpected or unwanted behaviour from the devices. The study plans to compare the two hardware styles regarding the benefit received from different microphone locations.
As human subjects are involved the validation falls under the definition of a clinical investigation. The validation will address the performance of the new chip using the ITE hardware, and ensure that there is no reduction in speech understanding between using the BTE and ITE hardware styles. Evaluating the overall performance of the Mermaid 9 ITE devices is important to validate that the end user is satisfied with the devices and that all user requirements are fulfilled. All features available in Mermaid 9 have been validated and are currently used on the market in Mermaid 9 BTE devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking is not possible as the differences in hardware between the devices is obvious. The subjects and Investigator will recognize which device is the new one and which is the comparator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All classifications of hearing loss (sensorineural, conductive, mixed)
- •If the hearing loss is conductive or mixed it must be approved for amplification by a physician
- •All shapes of hearing loss (flat, sloping, reverse slope, notch)
- •Severity ranging from mild to severe
- •German speaking
- •Current hearing aid users
- •Both genders
- •Ages 18 and older
- •Ability and willingness to sign the consent form
排除标准
- •Contraindications for amplification
- •Active ear disease
- •Inability to follow the procedures of the study due to language problems, psychological disorders, dementia, or other cognitive problems of the participant
- •A reduced mobility making them unable to attend weekly study appointments
- •Uncooperative so that it is not possible to record a valid pure tone audiogram
- •A strongly reduced dexterity
- •Central hearing disorders
- •Bernafon employees
- •Family members of Bernafon employees
结局指标
主要结局
Speech Intelligibility Performance
时间窗: Through study completion, an average of one month.
Speech test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the BTE device, and aided with the new ITE device. The test is the Oldenburg Sentence test (OLSA) and uses nonsense sentences. The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 decibels (dB) and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.
Word Recognition
时间窗: Through study completion, an average of one month.
Word recognition test scores will be measured with speech reception thresholds (SRTs) of speech in noise in three conditions: unaided, aided with the BTE device, and aided with the new ITE device. The test is called the Göttinger sentence test (GÖSA) and uses content relevant sentences that subjects repeat . The score is measured by the the signal-to-noise ratio (SNR) at which 50% of words in a sentence list are correctly repeated. The speech is always presented at 65 decibels (dB) and the background noise varies to maintain the 50% correct. A lower SNR score indicates a better score. The maximum score will be 15 dB and the minimum will be -5 dB.
次要结局
- Subjective Performance of Aided Benefit(Through study completion, an average of one month.)