A Standard Music Program Compared to an Optimized Music Program

A Clinical Investigation Comparing a Standard Hearing Aid Fitting Protocol and a Fitting Protocol Optimized for Musicians

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04147442

Enrollment

Registered

2019-11-01

Start date

2019-10-09

Completion date

2019-12-20

Last updated

2021-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss

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.

Interventions

DEVICEHearing aid with fine-tuned and standard programs

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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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.

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Preference Rating	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.

Secondary

Measure	Time frame	Description
Sound Perception Test - Pitch	0,10, and 20 days	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	0,10, and 20 days	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	0,10, and 20 days	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 - Brightness	0,10, and 20 days	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	0,10, and 20 days	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	0,10, and 20 days	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.
Sound Perception Test - Level	0,10, and 20 days	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.

Other

Measure	Time frame	Description
Occurrence of Device Related Adverse Events	0,10, and 20 days	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.

Countries

Switzerland

Participant flow

Participants by arm

Arm	Count
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.	20
Total	20

Baseline characteristics

Characteristic	Music Program Fine-tuned	—
Age, Continuous	67 years	—
Hearing Loss	46 decibels STANDARD_DEVIATION 16	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment Switzerland	20 participants	—
Sex: Female, Male Female	5 Participants	—
Sex: Female, Male Male	15 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 20
other Total, other adverse events	2 / 20
serious Total, serious adverse events	0 / 20

Outcome results

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.

Time frame: 20 days