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Hearing LossBF007-2101NCT04939259

A Comparative Clinical Investigation of Musician's Preference With Hearing Aids

A study testing New Music Program and Standard Listening Program in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hearing Loss
What is being tested?
New Music Program and Standard Listening Program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteSwitzerland
Study dates
1 Nov 2021to 6 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Both genders
  • Ages 18 and older
  • Ability and willingness to sign the consent form

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Bernafon AG

    Bern, 3018

Other trials in Switzerland

About this study

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

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.

Read the detailed 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.

Conditions
Hearing Loss
Being tested
New Music Program, Standard Listening Program
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New Music ProgramDevice

    A mini behind-the-ear hearing aid that amplifies sounds and directs them into the ear. The music program within the hearing aid will provide amplification specifically tuned for listening to music.

  • Standard Listening ProgramDevice

    A mini receiver-in-the-ear hearing aid that amplifies sounds and directs them into the ear. The standard listening program within the hearing aid will provide amplification specifically tuned for listening to speech and daily general sounds in the environment.

Study groups in NCT04939259
Study groupRoleWhat they receive
New Music ProgramExperimentalThe new hearing aid contains the new music program will be worn by all participants at the same time. The participants must switch between the two programs during use to make the comparison.
Receives: Device: New Music Program; Device: Standard Listening Program
Standard Listening ProgramActive comparatorThe new hearing aid also contains the standard listening program worn by all participants at the same time. The participants must switch between the two programs during use to make the comparison.
Receives: Device: New Music Program; Device: Standard Listening Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    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.

    Measured: 10 days

Secondary outcomes (3)
  1. 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.

    Patients will listen to various styles of recorded music in the test booth while switching between hearing aid programs labelled as A and B to make a direct comparison. The test is a forced choice between A and B selected on a touch screen. Patients will not know which program is A and which is B. This will be based on the original randomization assigned to them at visit one.

    Measured: 10 days

  2. 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.

    Patients will be tested in the sound booth with recorded music and make a forced choice between two pitch levels using the music program and using the standard listening program. The measurement scale is in decibels and a lower score signifies a better score. Patients must correctly identify four consecutive pitches before an average level is calculated.

    Measured: 0 days

  3. The average level at which patients correctly repeat sentences presented in background noise using the standardized Gottingen Sentence Test (GOSA).

    Recorded speech is presented in background noise using the standardized Gottingen Sentence Test (GOSA). The score is in signal-to-noise ratio with a lower score signifying a better answer. The sentences are presented at an adaptive level of the speech signal. The test is automated and changes the signal of the speech to maintain a 50% level of understanding.

    Measured: 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start1 Nov 2021
  3. Primary completion6 Dec 2021
  4. Study completion6 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All participants will wear the new devices at the same time. They will have the general listening program and the new music program available in the same device. They will switch between the programs to make the comparison in multiple environments.
Masking
Single blind
Who is masked
Participant
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939259
Sponsor's protocol ID
BF007-2101
Acronym
BF007-2101
Status last verified
Jul 2022
First submitted
8 Jun 2021
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The anonymized data that is shared in the report will be made available to other researchers.

Questions about this trial

What is this clinical trial studying?

A study testing New Music Program and Standard Listening Program in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.

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