Trial Outcomes & Findings for A Standard Music Program Compared to an Optimized Music Program (NCT NCT04147442)

NCT ID: NCT04147442

Last Updated: 2021-09-16

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 20 days
• Results posted on: 2021-09-16

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Music Program Fine-tuned n=20 Participants 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.
Age, Continuous	67 years n=20 Participants
Sex: Female, Male Female	5 Participants n=20 Participants
Sex: Female, Male Male	15 Participants n=20 Participants
Region of Enrollment Switzerland	20 participants n=20 Participants
Hearing Loss	46 decibels STANDARD_DEVIATION 16 • n=20 Participants

PRIMARY outcome

Timeframe: 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program 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. They will perform the test with the standard default music program.	Unaided The participants will perform the test with no hearing aids.
Preference Rating Fine-tuned Preference	14 Participants	—	—
Preference Rating Standard Preference	3 Participants	—	—
Preference Rating No Preference	3 Participants	—	—

SECONDARY outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program n=20 Participants 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. They will perform the test with the standard default music program.	Unaided n=20 Participants The participants will perform the test with no hearing aids.
Sound Perception Test - Pitch	1.4 hertz Standard Deviation 0.7	1.8 hertz Standard Deviation 0.6	1.9 hertz Standard Deviation 0.8

SECONDARY outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program 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. They will perform the test with the standard default music program.	Unaided The participants will perform the test with no hearing aids.
Music Sound Quality Rating Sound Quality-pleasant	0.66 units on a scale Standard Error 0.37	—	—
Music Sound Quality Rating Sound Quality-natural	0.69 units on a scale Standard Error 0.35	—	—

SECONDARY outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program n=20 Participants 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. They will perform the test with the standard default music program.	Unaided n=20 Participants The participants will perform the test with no hearing aids.
Sound Perception Test - Duration	31 milliseconds Standard Deviation 22	39 milliseconds Standard Deviation 24	35 milliseconds Standard Deviation 21

SECONDARY outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program n=20 Participants 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. They will perform the test with the standard default music program.	Unaided n=20 Participants The participants will perform the test with no hearing aids.
Sound Perception Test - Level	1.5 decibels Standard Deviation 0.7	1.7 decibels Standard Deviation 0.5	1.9 decibels Standard Deviation 1.0

SECONDARY outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program n=20 Participants 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. They will perform the test with the standard default music program.	Unaided n=20 Participants The participants will perform the test with no hearing aids.
Sound Perception Test - Brightness	0.4 decibels Standard Deviation 0.2	0.3 decibels Standard Deviation 0.2	0.5 decibels Standard Deviation 0.2

SECONDARY outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program n=20 Participants 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. They will perform the test with the standard default music program.	Unaided n=20 Participants The participants will perform the test with no hearing aids.
Sound Perception Test - Attack	158 hertz Standard Deviation 78.8	207.8 hertz Standard Deviation 97.8	197 hertz Standard Deviation 66.3

SECONDARY outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program n=20 Participants 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. They will perform the test with the standard default music program.	Unaided n=20 Participants The participants will perform the test with no hearing aids.
Sound Perception Test - Spectral Irregularities	5 decibels Standard Deviation 2	4 decibels Standard Deviation 2	5 decibels Standard Deviation 2

OTHER_PRE_SPECIFIED outcome

Timeframe: 0,10, and 20 days

Population: 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.

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.

Outcome measures

Measure	Music Program Fine-tuned and Standard n=20 Participants 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.	Music Standard Program 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. They will perform the test with the standard default music program.	Unaided The participants will perform the test with no hearing aids.
Occurrence of Device Related Adverse Events	0 Participants	—	—

Adverse Events

Music Program Fine-tuned

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Music Program Fine-tuned n=20 participants at risk 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.
Infections and infestations Cold	5.0% 1/20 • Number of events 20 • 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.
Injury, poisoning and procedural complications Foot Injury	5.0% 1/20 • Number of events 20 • 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.

Additional Information

Dr Barbara Simon

Bernafon AG

Phone: +41 31 998 1515

Email: bsim@bernafon.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place