Quality Control of CE-Certified Phonak Hearing Aids - Sonova2018_05
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sonova AG
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Comparison of the speech intelligibiltity of phone calls via direct streaming
研究概览
简要总结
Phonak Hearing Systems pass through different development and study stages. At an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. If the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing Systems undergo a final quality control in terms of clinical trials. This is a validation study, investigating optimized algorithms, features, functions and wearing comfort. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
详细描述
In this study a comparison with a CE-labeled Phonak Receiver-in-the-canal (RIC) device (active comparator) and two CE-labeled competitor devices (RIC) is done. All study devices contain direct connectivity functionality which will be compared in terms of streamed Audio quality, streaming stability and Usability preferences of all available functions and features. This will be a clinical evaluation which will be conducted mono centric at Sonova AG Headquarters based in Stäfa (Switzerland).
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
- Single (Participant)
盲法说明
Participant masking was only done for laboratory measurements. For home trial testing no masking was done.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult hearing impaired persons (minimum age: 18 years, mild to moderate Hearing loss) without hearing aid experience
- •Good written and spoken (Swiss) German language skills
- •Healthy outer ear
- •Ability to fill in a questionnaire (p/eCRF) conscientiously
- •willingness to wear Receiver in the canal hearing aids
- •Informed Consent as documented by signature
- •owning an iPhone 6 or higher
排除标准
- •Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
- •Limited mobility and not in the position to attend weekly appointments in Stäfa (Switzerland)
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid
- •Inability to produce a reliable hearing test result
- •Known psychological problems
- •Central hearing disorders
研究组 & 干预措施
Phonak Audéo B90-Direct
The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss.
干预措施: Phonak Audéo B90-Direct (Device)
HearingAid_A
HearingAid_A is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_A which will be fitted to the participants individual Hearing loss.
干预措施: HearingAid_A (Device)
HearingAid_B
HearingAid_B is the most recent Receiver-in-the-canal Hearing aid with direct connectivity functionality from manufacturer_B which will be fitted to the participants individual Hearing loss.
干预措施: HearingAid_B (Device)
结局指标
主要结局
Comparison of the speech intelligibiltity of phone calls via direct streaming
时间窗: 6 weeks
The primary outcome meaurement of this study is the comparison of Phonak's direct connectivity solution against two competitors in terms of subjective speech intelligibility of streamed audio signals via smartphone. The subjective speech intelligibilty will be measured via interview (sound quality rating, satisfaction rating of speech intelligibility) from far-end talker and near-end talker.
次要结局
- Investigation of Bluetooth Connection losses between Hearing Aid and smart phone during a phone call (number of reported interruptions during a phone call which will be streamed via bluetooth from Smartphone to Hearing Aid)(6 weeks)