Hearing LossNCT04147442
A Standard Music Program Compared to an Optimized Music Program
A study testing Hearing aid with fine-tuned and standard programs in people with Hearing Loss, run by Bernafon AG at 1 site in Switzerland.
Trial summary
The trial will test whether a standard music program that is an offset to the general program provides the same benefit as a music program that is individually customized for each test participant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aid with fine-tuned and standard programs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Oct 2019to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All classifications of hearing loss (sensorineural, conductive, mixed)
- If conductive or mixed, approval for amplification by a physician is needed
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to profound
- German or French speaking
- Play a musical instrument
- 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 study procedures due to language problems, psychological disorders, dementia, or other cognitive problems
- Unable to attend study appointments due to reduced mobility
Show all 12Show fewer
- Reduced ability to describe auditory impressions and usage of hearing aids
- Uncooperative so that it is ot possible to record a valid audiogram
- Severely reduced dexterity
- Central hearing disorders
- Sponsor employees
- Family members of employees of the Sponsor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Investigation Comparing a Standard Hearing Aid Fitting Protocol and a Fitting Protocol Optimized for Musicians
The trial will test whether a standard music program that is an offset to the general program provides the same benefit as a music program that is individually customized for each test participant. The trial seeks to investigate the benefit received by musicians that regularly play an instrument and belong to an organized music group or orchestra instead of people that listen to music.
Read the detailed description
The initial goal of hearing aids is to amplify speech and facilitate speech understanding especially in noise. Besides speech difficulty, people with hearing loss also report a reduced enjoyment of music. The hearing aid settings used for amplifying speech often have adverse effects on music.
For this study, the sponsor will carry out testing with participants with hearing loss to compare dedicated music programs. The current study will compare the standard music program available in the software to one that is fine-tuned for each subject. The hearing aids that will be used for the study are certified by the European Conformity and have been on the market for almost one year. The goal is to determine whether musicians will perceive a difference and prefer a fine-tuned music program over the default music program in real-life situations.
- Conditions
- Hearing Loss
- Being tested
- Hearing aid with fine-tuned and standard programs
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aid with fine-tuned and standard programsDevice
Also called Viron 9 mini receiver-in-the-ear hearing aid
A digital, wireless hearing aid is programmed specifically to each subject's hearing loss and fitted with both a program that is fine-tuned for their specific music playing as well as the standard music program that uses pre-determined settings.
| Study group | Role | What they receive |
|---|---|---|
| Music program fine-tuned and standard | Experimental | The fine-tuned program and the standard program will be compared within the same instrument as a hearing aid can have up to 4 different listening programs in it. Receives: Device: Hearing aid with fine-tuned and standard programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference Rating
Subjects will answer a questionnaire that asks them to choose which program that they preferred. The questionnaire gives Program 1 or Program 2 as the choices as well as a no Preference option for those that did not notice a difference between the two. The percentage of subjects that chose each Program will be calculated to determine if more preferred the optimized music program.
Measured: 20 days
Secondary outcomes (7)
Sound Perception Test - Pitch
The sound perception test is called the Adaptive Music Perception test. It is tested in the lab with digitally synthesized recordings of components of tones. It tests the overall perception of Meter with pitch (in Hz). A lower score is better. A higher score means that it took higher Levels of Hz to perceive a difference between musical notes.The subjects are tested in the unaided, aided with the standard program, and aided with the test (optimized) program. The scores will be averaged and analyzed to determine if one program results in better (lower) test scores.
Measured: 0,10, and 20 days
Music Sound Quality Rating
The sound quality of the devices when listening/playing music will be rated using a questionnaire. The questionnaire asks subjects to rate various aspects of the sound using a 5-point scale with 1 being the worst answer and 5 being the best. The questionnaire will be answered for Program 1 and Program 2. The scores for each question will be averaged across subjects and the difference between the two programs calculated to determine if one music program results in better sound quality scores. A positive score is in favor of the fine-tuned program and a negative score would be in favor of the standard program. They will test Program 1 and Program 2 during the same period as they have the ability to use a button on the Hearing aid to switch between programs.
Measured: 0,10, and 20 days
Sound Perception Test - Duration
The sound perception test is called the Adaptive Music Perception test. It is tested in the lab with digitally synthesized recordings of components of tones. It tests the overall perception of duration (in milliseconds). A lower score is better. A higher score means that it took longer in milliseconds to perceive a difference between musical notes.The subjects are tested in the unaided, aided with the standard program, and aided with the test (optimized) program. The scores will be averaged and analyzed to determine if one program results in better (lower) test scores.
Measured: 0,10, and 20 days
Sound Perception Test - Level
The sound perception test is called the Adaptive Music Perception test. It is tested in the lab with digitally synthesized recordings of components of tones. It tests the overall perception of Meter with Level (in decibels). A lower score is better. A higher score means that it took higher levels in dB to perceive a difference between musical notes.The subjects are tested in the unaided, aided with the standard program, and aided with the test (optimized) program. The scores will be averaged and analyzed to determine if one program results in better (lower) test scores.
Measured: 0,10, and 20 days
Sound Perception Test - Brightness
The sound perception test is called the Adaptive Music Perception test. It is tested in the lab with digitally synthesized recordings of components of tones. The perception of the Timber of music is tested by the brightness (measured in dB). Lower scores are better. A higher score means that it took higher levels in dB to perceive a difference between musical notes.The subjects are tested in the unaided, aided with the standard program, and aided with the test (optimized) program. The scores will be averaged and analyzed to determine if one program results in better (lower) test scores.
Measured: 0,10, and 20 days
Sound Perception Test - Attack
The sound perception test is called the Adaptive Music Perception test. It is tested in the lab with digitally synthesized recordings of components of tones. The perception of the Timber of music is tested by the attack (measured in Hz). Lower scores are better. A higher score means that it took higher levels in Hz to perceive a difference between musical notes.The subjects are tested in the unaided, aided with the standard program, and aided with the test (optimized) program. The scores will be averaged and analyzed to determine if one program results in better (lower) test scores.
Measured: 0,10, and 20 days
Sound Perception Test - Spectral Irregularities
The sound perception test is called the Adaptive Music Perception test. It is tested in the lab with digitally synthesized recordings of components of tones. The perception of the Timber of music is tested by the spectral irregularities (measured in dB). Lower scores are better. A higher score means that it took higher levels in dB to perceive a difference between musical notes.The subjects are tested in the unaided, aided with the standard program, and aided with the test (optimized) program. The scores will be averaged and analyzed to determine if one program results in better (lower) test scores.
Measured: 0,10, and 20 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start9 Oct 2019
- Primary completion30 Nov 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- The participants will have access to both music programs for 10 +/- 7 days. During this time they will use both programs and switch between them during music playing situations.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bernafon AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Simon, AuD, Principal investigator, Bernafon AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147442
- Sponsor's protocol ID
- BF006-1902
- Status last verified
- Jan 2021
- First submitted
- 9 Oct 2019
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation Comparing a Standard Hearing Aid Fitting Protocol and a Fitting Protocol Optimized for Musicians
- ClinicalTrials.gov ID
- NCT04147442
- Acronym / sponsor ID
- BF006-1902
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bernafon AGIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial will test whether a standard music program that is an offset to the general program provides the same benefit as a music program that is individually customized for each test participant. The trial seeks to investigate the benefit received by musicians that regularly play an instrument and belong to an organized music group or orchestra instead of people that listen to music.
Detailed description
The initial goal of hearing aids is to amplify speech and facilitate speech understanding especially in noise. Besides speech difficulty, people with hearing loss also report a reduced enjoyment of music. The hearing aid settings used for amplifying speech often have adverse effects on music.
For this study, the sponsor will carry out testing with participants with hearing loss to compare dedicated music programs. The current study will compare the standard music program available in the software to one that is fine-tuned for each subject. The hearing aids that will be used for the study are certified by the European Conformity and have been on the market for almost one year. The goal is to determine whether musicians will perceive a difference and prefer a fine-tuned music program over the default music program in real-life situations.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will have access to both music programs for 10 +/- 7 days. During this time they will use both programs and switch between them during music playing situations.
| Arm | Type | Receives |
|---|---|---|
| Music program fine-tuned and standard | Experimental | Device: Hearing aid with fine-tuned and standard programsThe fine-tuned program and the standard program will be compared within the same instrument as a hearing aid can have up to 4 different listening programs in it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All classifications of hearing loss (sensorineural, conductive, mixed)
- If conductive or mixed, approval for amplification by a physician is needed
- All shapes of hearing loss (flat, sloping, reverse slope, notch)
- Severity ranging from mild to profound
- German or French speaking
Key exclusion criteria (12 listed)
- Normal hearing
- Contraindications for amplification
- Active ear disease
- Don't play an instrument
- Inability to follow the study procedures due to language problems, psychological disorders, dementia, or other cognitive problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aid with fine-tuned and standard programsAlso: Viron 9 mini receiver-in-the-ear hearing aidA digital, wireless hearing aid is programmed specifically to each subject's hearing loss and fitted with both a program that is fine-tuned for their specific music playing as well as the standard music program that uses pre-determined settings. | Device | Music program fine-tuned and standard |
Primary outcome
Preference Rating
Time frame: 20 days
Subjects will answer a questionnaire that asks them to choose which program that they preferred. The questionnaire gives Program 1 or Program 2 as the choices as well as a no Preference option for those that did not notice a difference between the two. The percentage of subjects that chose each Program will be calculated to determine if more preferred the optimized music program.
7 secondary outcomes
Sound Perception Test - Pitch
Time frame: 0,10, and 20 days
Music Sound Quality Rating
Time frame: 0,10, and 20 days
Sound Perception Test - Duration
Time frame: 0,10, and 20 days
Sound Perception Test - Level
Time frame: 0,10, and 20 days
Sound Perception Test - Brightness
Time frame: 0,10, and 20 days
Sound Perception Test - Attack
Time frame: 0,10, and 20 days
Sound Perception Test - Spectral Irregularities
Time frame: 0,10, and 20 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Simon, AuD principal investigator
Bernafon AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid with fine-tuned and standard programs 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 7 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 16 Sep 2021. 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?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Preference Rating (time frame: 20 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 16 Sep 2021.