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临床试验/NCT05521308
NCT05521308已完成不适用

Investigating Hearing Aid Frequency Response Curves

Sonova AG2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2022年10月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Sonova AG
入组人数
33
试验地点
2
主要终点
Streaming Sound Quality Ratings

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. 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. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. 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.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • N2 - N4 Hearing losses
  • Health 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 daysInformed consent as documented by signature
  • Willingness to wear different styles of couplings
  • Willingness to wear binaural fitting
  • Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them)
  • Ability to travel throughout facility

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.

结局指标

主要结局

Streaming Sound Quality Ratings

时间窗: 60 minutes

Pre-filtered sound samples (based on frequency response curves) will be presented via a paired comparison task in which participants will determine which sound sample they prefer (i.e. better sound quality). Sound samples will be presented via hearing aids that are programmed to the participant's hearing loss. Participant's will be presented with two samples at a time and will choose which sample they prefer. For example, if Sample A was preferred over Sample B, then Sample A gets a score of 1. If Sample B was preferred over Sample A, then Sample B gets a score of 1. At the end of the task, scores will be tallied to determine which sample was preferred the most overall. There will be 5 different samples. The minimum value for the tallied score would be 0 (the sample was not preferred at all) and the maximum value would be 8 (implying that the sample was preferred in all trials). Higher scores mean that the sample was preferred more and lowers scores mean the sample was not preferred.

次要结局

  • Sound Quality Rating - Live - Counts(60 minutes)
  • Sound Quality Rating - Live - Preferences(60 minutes)
  • US Matrix Test in Quiet - SRT(30 Minutes)

研究者

发起方
Sonova AG
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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Investigating Hearing Aid Frequency Response Curves | 临床试验