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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hearing aid with fine-tuned and standard programs | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Device Related Adverse Events | 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. | 0,10, and 20 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Simon, AuD | Bernafon AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bernafon AG | Bern | 3018 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | Music Program Fine-tuned and Standard | 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. The hearing aid is a digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fitted with two programs. One is fine-tuned for their specific music playing and one is the standard music program based on pre-determined settings. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Music Program Fine-tuned | 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. Hearing aid with fine-tuned program: A digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fine-tuned for their specific music playing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Count of Participants | Participants | No | 20 days |
|
1 month
Definition of adverse Events does not differ. Subjects are questioned at each Appointment to determine whether an adverse Event occurred outside of the clinic during the field trials.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Music Program Fine-tuned | 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. Hearing aid with fine-tuned program: A digital, wireless hearing aid that is programmed specifically to each subject's hearing loss and fine-tuned for their specific music playing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cold | Infections and infestations | Systematic Assessment | Subject had a common cold with nasal congestion and sneezing. No Fever or coughing was reported. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Barbara Simon | Bernafon AG | +41 31 998 1515 | 1684 | bsim@bernafon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 27, 2019 | Oct 29, 2019 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 22, 2019 | Oct 9, 2019 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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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.
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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.
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|
|
| 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. | 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. | 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. | 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. | 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. | 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. | 0,10, and 20 days |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hearing Loss | Mean | Standard Deviation | decibels |
|
|
|
| Secondary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Mean | Standard Deviation | hertz | 0,10, and 20 days |
|
|
|
| Secondary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Mean | Standard Error | units on a scale | 0,10, and 20 days |
|
|
|
| Other Pre-specified | Occurrence of Device Related Adverse Events | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Count of Participants | Participants | 0,10, and 20 days |
|
|
|
| Secondary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Mean | Standard Deviation | milliseconds | 0,10, and 20 days |
|
|
|
| Secondary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Mean | Standard Deviation | decibels | 0,10, and 20 days |
|
|
|
| Secondary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Mean | Standard Deviation | decibels | 0,10, and 20 days |
|
|
|
| Secondary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Mean | Standard Deviation | hertz | 0,10, and 20 days |
|
|
|
| Secondary | 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. | There were 15 males and 5 females ranging in age from 24 to 81 years with a mean age of 67. The mean average Hearing loss was 46 dB HL with a standard deviation of 16 dB HL. | Posted | Mean | Standard Deviation | decibels | 0,10, and 20 days |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 2 |
| 20 |
|
| Foot Injury | Injury, poisoning and procedural complications | Systematic Assessment | Subject injured foot while Walking. It healed by itself and did not require any Treatment. |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |