Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04939259 |
Other study ID # |
BF007-2101 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 1, 2021 |
Est. completion date |
December 6, 2021 |
Study information
Verified date |
July 2022 |
Source |
Bernafon AG |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
For this study, Bernafon AG will carry out testing with participants that are musicians with
hearing loss to test the new music rationale. The current study will compare the standard
listening program to the music program based on the new rationale. The Bernafon hearing aids
used for the current study are CE- marked and the family of hearing aids have been on the
market for almost one year. The hardware used for this test will be released in early 2022.
The goal is to determine whether musicians will perceive a difference and prefer a music
program over the general listening program when listening or playing music in real-life
situations and to validate the performance of the hardware style before release to the
market. The devices used for the trial are the Bernafon Alpha 9 mBTE and as the control
device, the Bernafon Viron 9 miniRITE (MNR) behind-the-ear (BTE) hearing aids. The results of
the trial will be used to examine differences in the benefit provided by the two programs as
well as identify further optimization possibilities or new risks associated with the devices.
Objective measures will be made with Real Ear Measures (REM) to verify the output of the
hearing aids, and subjective differences will be measured with questionnaires, an adaptive
music perception test, and a forced choice AB listening preference test.
All participants are hearing impaired persons that play an instrument. The trial will consist
of a total of 2 appointments. For the field testing and the lab testing, the order of the
test programs (music or standard) will be randomized. It is expected that the music program
will perform better than the general listening program for perception and preference testing.
In summary, the primary goal of this study is to evaluate the performance of a music program
based on a new rationale and to validate the performance of the devices before the release of
a new style to the market.