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临床试验/NCT04939259
NCT04939259已完成不适用

A Comparative Clinical Investigation of Musician's Preference Between a General Listening Program and a New Music Rationale for Hearing Aids

Bernafon AG2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2021年11月1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
Bernafon AG
入组人数
13
试验地点
2
主要终点
The number of patients that prefer the music program for listening to music over the standard listening program as reported in the questionnaire that asks patients to choose a program and state the reason why it was preferred.

研究概览

简要总结

For this study, Bernafon AG will carry out testing with participants with hearing loss to compare a dedicated music program to a general listening program. The Bernafon hearing aids used for the current study are CEmarked and will be released to the market in early 2022. The goal is to determine whether musicians will perceive a difference and prefer the music program over the default listening program in real-life situations. The devices will also be validated for performance before their release to the market.

详细描述

The intended use of hearing aids is to amplify sounds to compensate for hearing loss. The initial goal is to amplify speech and facilitate speech understanding especially in noise. Research shows that wireless hearing aids are efficacious for older adults , and in general, an increase in satisfaction and substantial benefits are characteristic for the wireless hearing aids brought to market during in the last decade.

Music is proven to enhance the lives of older people, but many people report a reduction in their ability to enjoy music with a hearing loss. Amplification can be used to overcome a hearing impairment and return the joy of music to those with hearing loss. However, for listening to music or particularly, for musicians that play an instrument, the hearing aid settings used for amplifying speech often have adverse effects on music.

Amplification and signal processing within hearing aids are designed to mainly improve speech understanding. It is possible to model the acoustical characteristics of speech because they are defined by the human vocal tract characteristics and the articulation speed. This acoustical model of speech is then used as a guideline for optimizing signal processing within the hearing aid. This approach has shown limitations in terms of perceived sound quality when listening to recorded or live music due to the characteristics of music which show more variations than speech in terms of frequency range, sound level, modulation, and dynamic range. These differences suggest that a specific listening program should be used when music is present in the listening environment. The need to offer a music program for musicians and music enthusiasts is also motivated by 1) the prevalence of hearing loss and associated audiological symptoms among musicians or music listeners exposed to high sound levels (and 2) the benefit (social, cognitive, and physical) of playing or listening to music especially for hearing impaired and seniors.

An optimization procedure based on the participation of the musician during the fitting procedure showed promising results in terms of preference when playing music and in discrimination thresholds of level, duration, and pitch. However, this procedure targets only musicians who actively play music and requires time, some specific knowledge, and the possibility to make the adjustments in the fitting room. A new fitting rationale dedicated to music was therefore developed and made available in the fitting software.

This new music rationale can be offered to any hearing aid user who wants an optimal listening experience when playing or listening to music (live, over a playback setup, or streaming from wireless device). The new music rationale is programmed based on the hearing loss and uses different gain shaping and kneepoints in the dynamic compression compared to the general listening program. Specific settings of signal processing features like directionality, noise reduction, or feedback cancellation are either turned off or set at a lower level than in the general listening program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

The order of the programs is blinded so that subjects don't know which slot (2 or 3) contains the music program or the general program. Slot 1 always has a general program for everyday speech understanding.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

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
  • Play a musical instrument
  • Both genders
  • Ages 18 and older
  • Ability and willingness to sign the consent form

排除标准

  • Normal hearing
  • Contraindications for amplification
  • Active ear disease
  • Don't play an instrument
  • 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
  • A reduced ability to describe auditory impressions and the usage of the hearing aids
  • 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

The number of patients that prefer the music program for listening to music over the standard listening program as reported in the questionnaire that asks patients to choose a program and state the reason why it was preferred.

时间窗: 10 days

A questionnaire will ask patients to choose between the music program and the standard listening program as their preferred program for listening to music. It is not a forced choice as they also have the option to choose "no preference." They are then asked to choose from a checkbox with a list of possible reasons for the preference as well as the ability to write in additional reasons.

次要结局

  • The number of patients that prefer the sound quality of the music program over the standard listening program measured with a forced choice A/B question on a touch screen.(10 days)
  • The average level at which patients correctly repeat sentences presented in background noise using the standardized Gottingen Sentence Test (GOSA).(10 days)
  • The average level of decibels at which patients are able to discriminate the changes in pitch of recorded music samples as measured with a standardized test called the Adaptive Music Perception (AMP) test.(0 days)

研究者

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

研究点 (2)

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