Investigating the DNN Noise Reduction Feature in Phonak Hearing Aids Using Ecological Momentary Assessment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Sonova AG
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- AZBio Sentence Test
研究概览
简要总结
The goal of this interventional study is to evaluate the DNN Noise reduction feature of Phonak hearing aids in adults with moderate to moderate severe hearing loss. The main questions it aims to answer are:
Do participants correctly identify significantly more words on the AZBio Sentence Test when using Phonak's DNN NR feature than when using Competitor device A in a lab setting? Do participants subjectively rate the speech clarity, ease of listening, and listening confidence higher when using Phonak's DNN feature than when using Competitor device A in both a lab setting and a real-world cafe setting? Do participants have an overall preference for the Phonak device over the Competitor device A in a real-world cafe setting?
Participants will be fit with both the Phonak device and a Competitor device A in the lab. They will be given the AZBio Sentence test and repeat as many words as they can in a simulated noisy environment. Following the lab visit, participants will meet in a group with three other conversation partners in a real-world setting and asked to complete subjective questionnaires during the visit.
详细描述
Participants will undergo a hearing aid fitting for both the Phonak device and the Competitor device A. In the lab, participants will be seated in the center of a 10-speaker array. Diffuse ecologically valid noise will be coming from all 10 speakers, while recorded sentences will be presented one at a time randomly from 4 speakers in front of the participant. Participants will be given two lists of 25 sentences for each hearing aid condition, and will repeat as many words as they can. Percentage correct will be calculated for each hearing aid condition. The second appointment will consist of a real-world visit to a local cafe, in which they will be seated at a table with three other conversation partners. During the cafe visit, participants will be asked to answer questions about their perceived speech clarity, ease of listening, and listening confidence with each of the two devices. Participants will be blinded as to which devices they are wearing for both the lab visit and the real world cafe visit.
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
Participants will be blinded as to which hearing aid they are wearing during all of the testing.
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
- •Adults (18+ years old) with audiograms within fitting range of the hearing aid (e.g., moderate to severe sensorineural hearing losses {N3-N5}) and with hearing aid experience will be recruit-ed for this study.
- •Ability to fill out questionnaires
- •No known cognitive issues.
- •Fluent in English, ability to read and write in English.
- •Informed consent documented by signature.
- •Willingness to wear binaural receiver-in-canal (RIC) devices with domes.
- •Willingness to meet up outside of the lab at a local café with two other consented research participants.
排除标准
- •Contraindications to medical device (MD) in this study: known hypersensitivity or allergy to investigational product/domes.
- •Limited mobility/not being able to come to scheduled appoint-ments.
- •Limited ability to describe listening impressions/experiences and the use of the hearing aid.
- •Known psychological disorders.
研究组 & 干预措施
Participants fit and tested with the Phonak device first, then the Competitor device A.
Participants that are tested first with the Phonak device, and then with the Competitor device A.
干预措施: Phonak Audeo Infinio Hearing Aid (Device)
Participants fit and tested with the Phonak device first, then the Competitor device A.
Participants that are tested first with the Phonak device, and then with the Competitor device A.
干预措施: Competitor Device A (Device)
Participants fit and tested with Competitor device A first, then with Phonak device.
Participants that are tested first with the Competitor device A, then with the Phonak device.
干预措施: Phonak Audeo Infinio Hearing Aid (Device)
Participants fit and tested with Competitor device A first, then with Phonak device.
Participants that are tested first with the Competitor device A, then with the Phonak device.
干预措施: Competitor Device A (Device)
结局指标
主要结局
AZBio Sentence Test
时间窗: Day 1 of study
A validated speech perception test consisting of 25 different lists of sentences. Sentences are presented via a loudspeaker at a pre-determined level and the number of words correctly repeated are calculated into a percenteage. The higher the percentage, the better the participant's speech perception.
次要结局
- Composite Questionnaire(Days 1 and 2 of study)