Investigating Hearing Aid Frequency Response Curves 2
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
- Sound Quality Ratings - Listening Comfort - Program 1
研究概览
简要总结
Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. Based on the conclusions of the first study, we have identified areas that require further analysis and testing prior to implementing of the proposed frequency response curve into our products. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.
详细描述
Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality and listener comfort. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music and while in different listening enviroments.
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
盲法说明
Participant were blinded to the type of intervention (i.e., hearing aid curve) or program they were comparing or rating. They were simply asked to specify which intervention they had a preference for.
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
- 是
入选标准
- •N3 - N5 Hearing losses
- •Healthy Outer ear
- •No visible congenital or traumatic deformity of the outer ear
- •Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
- •Ability to answer questions and repeat sentences
- •No history of problematic tinnitus or pain/discomfort from loud sounds
- •No history of active drainage from the ears in the past 90 days
- •Willingness to wear different styles of couplings
- •Willingness to wear binaural fitting
- •Experienced Users = more than 3 months of hearing aid experience
- •Ability to travel to Sonova facilities
排除标准
- •Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
- •Limited mobility/not able to come to the scheduled visit
- •Inability to produce reliable hearing test results
- •History of active drainage from the ear in the previous 90 days
- •Abnormal appearance of the eardrum and ear canal.
研究组 & 干预措施
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Variation #1 under Program 3 (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Standard Curve under Program 1 (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Variation #1 under Program 1 (Device)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Variation #2 under Program 5 - Streaming Only (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Variation #3 under Program 5 - Streaming Only (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Variation #4under Program 5 - Streaming Only (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Standard Curve under Program 2 (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Variation #1 under Program 2 (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Standard Curve under Program 3 (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Standard Curve under Program 4 (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Hearing Aid - Variation #1 under Program 4 (Other)
Participants with Hearing Loss
Individuals with hearing loss that meet the candidacy to wear hearing aids. All interventions are associated with the fitting of binaural hearing aids with various coupling methods. All participants will be assessed under all interventions.
干预措施: Unaided (Other)
结局指标
主要结局
Sound Quality Ratings - Listening Comfort - Program 1
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Overall Preference - Program 1
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Speech Clarity - Program 1
时间窗: 10 minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Noise Intrusion - Program 1
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Listening Comfort - Program 2
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Overall Preference - Program 2
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Noise Intrusion - Program 2
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Listening Comfort - Program 3
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program provides increased listening comfort. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Overall Preference - Program 3
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Speech Clarity - Program 3
时间窗: 10 minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program has better speech clarity. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Noise Intrusion - Program 3
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (Standard curve and variation #1) and determine which program has more noise intrusion. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials ran and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
Sound Quality Ratings - Overall Preference - Program 4
时间窗: 10 Minutes
Participants will be asked to wear hearing aids and as they are exposed to listening environments. They will be asked to toggle between the two hearing aid programs (standard curve and variation #1) and determine which program they prefer to listen to. Participants will be asked to make these ratings while seated in a sound booth. Scores will be tallied at the end to see which program of the two was preferred more in the different listening environments. Scores can range from 0 (the program was not preferred at all) to unlimited (dependent on the numbers of trials run and samples tested). Higher scores will indicate that the program was preferred more than the other program and lowers scores mean the program was not preferred when compared to the other program.
次要结局
- US Matrix Test in Noise Results - dB SNR 50%(30 Minutes)
- Sound Quality Ratings - Streaming(1 hour)