Back to resultsA Standard Music Program Compared to an Optimized Music Program
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hearing aid with fine-tuned and standard programs
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Bernafon AG
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Music program fine-tuned and standard
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04147442
Brief Title
A Standard Music Program Compared to an Optimized Music Program
Official Title
A Clinical Investigation Comparing a Standard Hearing Aid Fitting Protocol and a Fitting Protocol Optimized for Musicians
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bernafon AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
The allotted program position for the music programs will be randomized. Half of the participants will have the fine-tuned program in slot 2 and half will have it in slot 3. They will not know in which position the fine-tuned program is versus the standard program.
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music program fine-tuned and standard
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Hearing aid with fine-tuned and standard programs
Other Intervention Name(s)
Viron 9 mini receiver-in-the-ear hearing aid
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preference Rating
Description
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.
Time Frame
20 days
Secondary Outcome Measure Information:
Title
Sound Perception Test - Pitch
Description
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.
Time Frame
0,10, and 20 days
Title
Music Sound Quality Rating
Description
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.
Time Frame
0,10, and 20 days
Title
Sound Perception Test - Duration
Description
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.
Time Frame
0,10, and 20 days
Title
Sound Perception Test - Level
Description
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.
Time Frame
0,10, and 20 days
Title
Sound Perception Test - Brightness
Description
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.
Time Frame
0,10, and 20 days
Title
Sound Perception Test - Attack
Description
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.
Time Frame
0,10, and 20 days
Title
Sound Perception Test - Spectral Irregularities
Description
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.
Time Frame
0,10, and 20 days
Other Pre-specified Outcome Measures:
Title
Occurrence of Device Related Adverse Events
Description
The number of Device Related Adverse Events will be monitored and totaled. Each Adverse Event is measured using a severity scale of: mild, moderate, or severe. The causality is measured with a scale of: Not related, unlikely, possible, probable, and causal relationship.
Time Frame
0,10, and 20 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Simon, AuD
Organizational Affiliation
Bernafon AG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bernafon AG
City
Bern
ZIP/Postal Code
3018
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Standard Music Program Compared to an Optimized Music Program
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