Hearing Loss
Conditions
Brief summary
Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE (Behind-The-Ear) hearing aids and given access to the myPhonak Junior hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings.
Interventions
DEVICEMyPhonak Junior App
The app is an accessory to the hearing aids which allows the user to make adjustments to their hearing aid in real-time. The hearing aid does not require the use of the app, but the objective of this study is to evaluate the effects of the user adjustments made via the app on the participant's speech intelligibility with the hearing aid.
DEVICEPhonak Sky hearing aid
A Behind-The-Ear hearing aid (BTE) fit to hearing impaired persons with mild to severe hearing loss.
Sponsors
Sonova AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Children and adolescents between the ages of 7 and 17 years old. * bilateral mild to severe hearing loss * experienced hearing aid users for 6+ months
Exclusion criteria
* any additional disabilities to the hearing impairment * inability to complete the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test | Day 1 of study, repeated on Day 14 of study | Target speech is presented from a speaker in front of participant while background noise is presented from 4 surrounding speakers. The level of noise is presented at 65 dB SPL (Sound Pressure Level),with target speech presented at variable levels, both louder and softer than the noise. The dB SNR is the level at which the participant can correctly repeat 50% of the words. A lower/negative dB SNR is better, indicating that 50% of the speech is understood when noise is louder than or close to the level of speech. This test was given in three, randomized conditions for each participant at two visits: 1) hearing aids in Automatic, 2) hearing aids in Automatic but Directionality and Noise Reduction customized by participant using the app (i.e. preferred settings), and 3) hearing aids in Automatic but with the Directionality set to lowest level 0, (i.e. omnidirectional), and Noise Reduction set to the highest level 10,or all the way on (i.e., extreme).Results of both visits was averaged |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Hearing Situations in Children's Every Day Lives Questionnaire | Completion of first home trial at day 7, and completion of second home trial at day 14 | A German-language questionnaire which asks student to rate their listening quality in different environments. Participants compared their listening quality with hearing aids alone versus hearing aids plus the app. Rating scale is from 1 to 5 with 1 = mostly easy and 5 = mostly difficult, so a lower score is better, however a rating of 0 = no change. Participants were given one copy of questionnaire to fill out during week 1 of home trial, and a second copy to fill out during week 2 of home trial. Results are reported separately for week 1 and week 2. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Study Group Participants age 8-17 with bilateral hearing loss will be fit with Phonak BTE hearing aids and given access to the Phonak hearing app. The participants will use the app to adjust the hearing aid microphone and noise reduction settings. | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Experimental Study Group | — |
|---|---|---|
| Age, Customized | 12 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Germany | 16 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test
Target speech is presented from a speaker in front of participant while background noise is presented from 4 surrounding speakers. The level of noise is presented at 65 dB SPL (Sound Pressure Level),with target speech presented at variable levels, both louder and softer than the noise. The dB SNR is the level at which the participant can correctly repeat 50% of the words. A lower/negative dB SNR is better, indicating that 50% of the speech is understood when noise is louder than or close to the level of speech. This test was given in three, randomized conditions for each participant at two visits: 1) hearing aids in Automatic, 2) hearing aids in Automatic but Directionality and Noise Reduction customized by participant using the app (i.e. preferred settings), and 3) hearing aids in Automatic but with the Directionality set to lowest level 0, (i.e. omnidirectional), and Noise Reduction set to the highest level 10,or all the way on (i.e., extreme).Results of both visits was averaged
Time frame: Day 1 of study, repeated on Day 14 of study
Population: All participants who completed the testing for at least one clinic visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Study Group | dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test | dB SNR for Automatic program, both visits averaged | -1.33 dB | Standard Deviation 3.93 |
| Experimental Study Group | dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test | dB SNR for preferred settings of volume, NR, and Directionality, both visits averaged | -2.83 dB | Standard Deviation 3.37 |
| Experimental Study Group | dB SNR (Decibel Signal to Noise Ratio) Score Using the OLSA (Oldenburg Sentence Test) Speech in Noise Test | dB SNR for extreme setting, both visits averaged | 0.08 dB | Standard Deviation 4.15 |
p-value: <0.001Durbin-Conover Pairwise Comparison
Comparison: A Shapiro Wilks test was used to test for normal distribution of the data.p-value: <0.001Durbin-Conover Pairwise Comparison
Comparison: A Shapiro Wilks test was used to test for normal distribution of the data.p-value: 0.002Durbin-Conover Pairwise Comparison
Secondary
Assessment of Hearing Situations in Children's Every Day Lives Questionnaire
A German-language questionnaire which asks student to rate their listening quality in different environments. Participants compared their listening quality with hearing aids alone versus hearing aids plus the app. Rating scale is from 1 to 5 with 1 = mostly easy and 5 = mostly difficult, so a lower score is better, however a rating of 0 = no change. Participants were given one copy of questionnaire to fill out during week 1 of home trial, and a second copy to fill out during week 2 of home trial. Results are reported separately for week 1 and week 2.
Time frame: Completion of first home trial at day 7, and completion of second home trial at day 14
Population: All participants who completed at least one home trial and one questionnaire.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental Study Group | Assessment of Hearing Situations in Children's Every Day Lives Questionnaire | Rating of listening quality Hearing Aid only first home trial | 2.61 score on a scale | Standard Deviation 1.36 |
| Experimental Study Group | Assessment of Hearing Situations in Children's Every Day Lives Questionnaire | Average rating of listening quality Hearing Aid with app adjustments first home trial | 1.88 score on a scale | Standard Deviation 1.16 |
| Experimental Study Group | Assessment of Hearing Situations in Children's Every Day Lives Questionnaire | Rating of listening quality Hearing Aid only second home trial | 2.42 score on a scale | Standard Deviation 1.54 |
| Experimental Study Group | Assessment of Hearing Situations in Children's Every Day Lives Questionnaire | Rating of listening quality Hearing Aid with app adjustments second home trial | 1.55 score on a scale | Standard Deviation 1.05 |
p-value: <0.001t-test, 2 sided
Comparison: Analysis of second home trialp-value: <0.001t-test, 2 sided