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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
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Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.
The purpose of this study is to evaluate the preferences for hearing aid noise reduction settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing aid Bluetooth streaming programs for this population. Subjective preferences will be obtained by having the participants listen to a noisy scene with different levels of noise reduction, to which they are blinded, and rate their preference. Blinded objective speech performance testing will be completed by a) finding the signal-to-noise ratio at which participant can correctly repeat back 50% of the target words, and b) measuring the percent of words correctly repeated during a noisy listening task. These tasks will be done using different levels of noise reduction. Subjective preferences for accessing Bluetooth streaming will also be obtained by asking participants which method they prefer (phone, hearing aid, or touch control).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Hearing Aid | Device | Commercially available hearing aid with various noise reduction strengths |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Rating of Listening Effort Questionnaire | Participant will rate perceived listening effort during a speech in noise task with different levels of noise reduction. Participants will rate how easy the task seemed using a sliding scale with 100 increments between two verbal anchors: "it was very easy" to "it was not easy at all". Higher scores indicate higher perceived listening effort. A rating of "0" would indicate "it was very easy" to understand the speech while a rating of "100" would indicate "it was not easy at all" to understand the speech. | Day 14 of study, visit 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Reception Threshold | The signal to noise ratio in which participant can correctly repeat 50% of key words at different levels of noise reduction, known as SNR50. A lower number is better, as it indicates that the words do not have to be presented at a much higher level than the noise in order for the person to understand 50% of the words. For example, an SNR of 2 dB means that the words are 2 dB louder than the noise, and SNR of 0 dB means that the words and the noise are at the same level, etc. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
No individual participant data will be shared with other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature. Phonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature. Phonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Subjective Rating of Listening Effort Questionnaire | Participant will rate perceived listening effort during a speech in noise task with different levels of noise reduction. Participants will rate how easy the task seemed using a sliding scale with 100 increments between two verbal anchors: "it was very easy" to "it was not easy at all". Higher scores indicate higher perceived listening effort. A rating of "0" would indicate "it was very easy" to understand the speech while a rating of "100" would indicate "it was not easy at all" to understand the speech. | All participants who completed the testing except three identified outliers (two who never wore hearing aids and one who was not able to complete activities assigned during the home trial) | Posted | Mean | Standard Deviation | units on a scale | Day 14 of study, visit 2 |
|
28 days
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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 | Experimental | Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature. Phonak Hearing Aid: Commercially available hearing aid with various noise reduction strengths |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Sonova US | 630-821-5000 | phonakaudiologyresearch@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 30, 2023 | Dec 5, 2023 | Prot_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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All participants will be fit with hearing aids with the same noise reduction feature. This feature has distinct, discrete levels of noise reduction which will be evaluated by the participants.
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Participants will be blinded as to which noise reduction setting they are listening to during lab visit objective testing only.
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| Day 28, visit 3 |
| Physical Response Time | Length of time(in milliseconds) it takes participant to respond physically by pressing a button while also performing a verbal task. Participants repeat the word they hear, while at the same time, are instructed to press a button if the word they hear is an object "bigger than a basketball". A higher response time may indicate increased listening effort. | Day 14 of study, visit 2 |
| Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings | A blinded paired comparison between two different settings of noise reduction (NR), while listening to a story presented in noise. Participants indicate whether they prefer listening to setting "A" or setting "B". Investigator will switch the settings so that participant is not aware of what the settings are. There will be a total of 18 trials; 12 which will compare OFF to either WEAK or STRONG, and six trials will compare WEAK to STRONG. The preferred setting will be determined by counting which setting is chosen most often from those six trials. The outcome measure data will report a count of participants who preferred OFF to their chosen setting, who preferred their chosen setting to OFF, and those who chose OFF and their preferred setting an equal number of times. | Day 1 of study, visit 1 |
| Subjective Questionnaire on Preference for Accessing Bluetooth on Phone | Subjective questionnaire about streaming access preferences. Participants will indicate which method (Hearing aid push button, phone control, or tap control on hearing aid) for answering phone calls and listening to audio streaming on phone. | Day 28, visit 3 |
| Verbal Response Accuracy | Out of 25 monosyllabic words presented in noise at different levels of noise reduction, the number of words the participant correctly repeats,while also performing a visual task. No statistical analysis was performed for this test. | Day 14 of study, visit 2 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Speech Reception Threshold | The signal to noise ratio in which participant can correctly repeat 50% of key words at different levels of noise reduction, known as SNR50. A lower number is better, as it indicates that the words do not have to be presented at a much higher level than the noise in order for the person to understand 50% of the words. For example, an SNR of 2 dB means that the words are 2 dB louder than the noise, and SNR of 0 dB means that the words and the noise are at the same level, etc. | All participants who completed the task except three identified outliers. | Posted | Mean | Full Range | decibels (dB) | Day 28, visit 3 |
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| Secondary | Physical Response Time | Length of time(in milliseconds) it takes participant to respond physically by pressing a button while also performing a verbal task. Participants repeat the word they hear, while at the same time, are instructed to press a button if the word they hear is an object "bigger than a basketball". A higher response time may indicate increased listening effort. | All participants who were able to complete the task excluding three outliers who were excluded from all analyses and one participant who was unable to perform this task. | Posted | Mean | Standard Deviation | milliseconds | Day 14 of study, visit 2 |
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| Secondary | Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings | A blinded paired comparison between two different settings of noise reduction (NR), while listening to a story presented in noise. Participants indicate whether they prefer listening to setting "A" or setting "B". Investigator will switch the settings so that participant is not aware of what the settings are. There will be a total of 18 trials; 12 which will compare OFF to either WEAK or STRONG, and six trials will compare WEAK to STRONG. The preferred setting will be determined by counting which setting is chosen most often from those six trials. The outcome measure data will report a count of participants who preferred OFF to their chosen setting, who preferred their chosen setting to OFF, and those who chose OFF and their preferred setting an equal number of times. | All participants who completed the task excluding three identified outliers who were excluded from all analyses. | Posted | Count of Participants | Participants | Day 1 of study, visit 1 |
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| Secondary | Subjective Questionnaire on Preference for Accessing Bluetooth on Phone | Subjective questionnaire about streaming access preferences. Participants will indicate which method (Hearing aid push button, phone control, or tap control on hearing aid) for answering phone calls and listening to audio streaming on phone. | All participants who completed testing excluding three identified outliers and one participant who did not use Tap Control during the home trial period. | Posted | Count of Participants | Participants | Day 28, visit 3 |
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| Secondary | Verbal Response Accuracy | Out of 25 monosyllabic words presented in noise at different levels of noise reduction, the number of words the participant correctly repeats,while also performing a visual task. No statistical analysis was performed for this test. | All participants who completed the task excluding three identified outliers who were excluded from all analyses. | Posted | Mean | Full Range | words repeated correctly | Day 14 of study, visit 2 |
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| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| SNR50 with NR setting at STRONG |
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| Title | Measurements |
|---|---|
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| Response time with NR at a custom setting |
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| Title | Measurements |
|---|---|
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| NR setting CUSTOM |
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