An interventional study of MyPhonak Junior App and Phonak Sky hearing aid in Hearing Loss, sponsored by Sonova AG. Completed at 1 site in Germany. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Sonova AG · Not applicable, Interventional, and Other
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.
1,109 studies on the registry are indexed under Hearing Loss; 233 are open to participants now.
This study's enrollment of 16 is below the median of 40 across 778 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Sonova AG is the lead sponsor of 88 studies on the registry; 6 are open to participants now.
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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.
Device: MyPhonak Junior App · Device: Phonak Sky hearing aid
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.
A Behind-The-Ear hearing aid (BTE) fit to hearing impaired persons with mild to severe hearing loss.
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
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
| Milestone | Experimental Study Group |
|---|---|
| Started | 16 |
| Completed | 15 |
| Not completed | 1 |
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
| dB | Experimental Study Group |
|---|---|
| dB SNR for Automatic program, both visits averaged | -1.33 ± 3.93 |
| dB SNR for preferred settings of volume, NR, and Directionality, both visits averaged | -2.83 ± 3.37 |
| dB SNR for extreme setting, both visits averaged | 0.08 ± 4.15 |
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.
| score on a scale | Experimental Study Group |
|---|---|
| Rating of listening quality Hearing Aid only first home trial | 2.61 ± 1.36 |
| Average rating of listening quality Hearing Aid with app adjustments first home trial | 1.88 ± 1.16 |
| Rating of listening quality Hearing Aid only second home trial | 2.42 ± 1.54 |
| Rating of listening quality Hearing Aid with app adjustments second home trial | 1.55 ± 1.05 |
Collected over 9 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Study Group | 0/16 (0%) | 0/16 (0%) | 0/16 (0%) |
| Age, Customized(years) | Experimental Study Group |
|---|---|
| Median | 12 (8 to 17) |
| Sex: Female, Male(Participants) | Experimental Study Group |
|---|---|
| Female | 8 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Experimental Study Group |
|---|
| Region of Enrollment(participants) | Experimental Study Group |
|---|---|
| Germany | 16 |
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