Hearing Loss
Conditions
Brief summary
Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.
Detailed description
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). .
Interventions
DEVICEPhonak Hearing Aid
Commercially available hearing aid with various noise reduction strengths
Sponsors
Vanderbilt University
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Participants will be blinded as to which noise reduction setting they are listening to during lab visit objective testing only.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* mild, moderate, or moderate-severe bilateral sensorineural hearing loss * native English speakers with ability to communicate verbally * able to read and follow directions * access to smartphone and willing to download a hearing aid app * experienced hearing aid user (6+ months)
Exclusion criteria
* unable to follow verbal directions * unable to communicate verbally * unable to wear study devices for required home trials * active middle ear infection * unable to attend lab visits required for study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Rating of Listening Effort Questionnaire | Day 14 of study, visit 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Reception Threshold | Day 28, visit 3 | 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. |
| Physical Response Time | Day 14 of study, visit 2 | 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. |
| Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings | Day 1 of study, visit 1 | 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. |
| Subjective Questionnaire on Preference for Accessing Bluetooth on Phone | Day 28, visit 3 | 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. |
| Verbal Response Accuracy | Day 14 of study, visit 2 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 18 |
| Total | 18 |
Baseline characteristics
| Characteristic | Experimental | — |
|---|---|---|
| Age, Continuous | 14.33 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 18 Participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
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.
Time frame: Day 14 of study, visit 2
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Subjective Rating of Listening Effort Questionnaire | Subjective rating with NR OFF | 44.73 units on a scale | Standard Deviation 27.54 |
| Experimental | Subjective Rating of Listening Effort Questionnaire | Subjective rating with NR at custom setting | 44.5 units on a scale | Standard Deviation 27.45 |
| Experimental | Subjective Rating of Listening Effort Questionnaire | Subjective rating with NR at WEAK | 41.53 units on a scale | Standard Deviation 26.7 |
| Experimental | Subjective Rating of Listening Effort Questionnaire | Subjective rating with NR at STRONG | 35.86 units on a scale | Standard Deviation 26.91 |
Comparison: Fixed factor of program and random intercept of participantp-value: 0.007Mixed Models Analysis
Comparison: Follow up comparison between noise reduction setting OFF and noise reduction setting STRONGp-value: <0.05Mixed Models Analysis
Comparison: Follow up comparison between noise reduction setting STRONG and noise reduction setting WEAKp-value: <0.01Mixed Models Analysis
Comparison: Follow up comparison between ratings of effort with OFF and WEAKp-value: >0.05Mixed Models Analysis
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.
Time frame: Day 14 of study, visit 2
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Physical Response Time | Response time with NR OFF | 2452.65 milliseconds | Standard Deviation 561.43 |
| Experimental | Physical Response Time | Response time with NR WEAK | 2432.16 milliseconds | Standard Deviation 509.75 |
| Experimental | Physical Response Time | Response time with NR STRONG | 2388.25 milliseconds | Standard Deviation 468.62 |
| Experimental | Physical Response Time | Response time with NR at a custom setting | 2367.7 milliseconds | Standard Deviation 448.7 |
Comparison: Analysis was done only between NR OFF and NR at a custom or preferred setting.p-value: 0.145Mixed Models Analysis
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.
Time frame: Day 28, visit 3
Population: All participants who completed the task except three identified outliers.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental | Speech Reception Threshold | SNR50 with NR setting OFF | 1.01 decibels (dB) |
| Experimental | Speech Reception Threshold | SNR50 with NR setting WEAK | 1.02 decibels (dB) |
| Experimental | Speech Reception Threshold | SNR50 with NR setting MODERATE | 1.02 decibels (dB) |
| Experimental | Speech Reception Threshold | SNR50 with NR setting at STRONG | 1.02 decibels (dB) |
p-value: 0.283Mixed Models Analysis
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.
Time frame: Day 1 of study, visit 1
Population: All participants who completed the task excluding three identified outliers who were excluded from all analyses.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental | Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings | Preferred NR off | 1 Participants |
| Experimental | Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings | Preferred NR at individual preferred setting | 5 Participants |
| Experimental | Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings | Preferred OFF and preferred setting the same | 9 Participants |
Comparison: An exact binomial test was performed to evaluate if the majority of teens and pre-teens with mild to severe hearing loss preferred NR setting (i.e., either weak or strong) to the NR setting OFF.p-value: 0.3018Exact Binomial test
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.
Time frame: Day 28, visit 3
Population: All participants who completed testing excluding three identified outliers and one participant who did not use Tap Control during the home trial period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental | Subjective Questionnaire on Preference for Accessing Bluetooth on Phone | Prefer tapping to answer phone call over using phone or hearing aid button | 8 Participants |
| Experimental | Subjective Questionnaire on Preference for Accessing Bluetooth on Phone | Prefer tapping to access voice assistant over using phone control or hearing aid button | 6 Participants |
| Experimental | Subjective Questionnaire on Preference for Accessing Bluetooth on Phone | Prefer tapping to access streaming over using phone controls or hearing aid button | 10 Participants |
Comparison: Exact binomial test was done to evaluate if the majority (\>50%) of teens and pre-teens prefer to use Tap Control to access Bluetooth streaming, compared to using the HA push button or phone controls.p-value: 0.1796Exact Binomial test
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.
Time frame: Day 14 of study, visit 2
Population: All participants who completed the task excluding three identified outliers who were excluded from all analyses.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Experimental | Verbal Response Accuracy | Noise Reduction setting OFF | 14.37 words repeated correctly |
| Experimental | Verbal Response Accuracy | Noise Reduction setting WEAK | 14.17 words repeated correctly |
| Experimental | Verbal Response Accuracy | Noise Reduction setting STRONG | 13.93 words repeated correctly |
| Experimental | Verbal Response Accuracy | NR setting CUSTOM | 14.3 words repeated correctly |