Trial Outcomes & Findings for MyPhonak App Junior Pediatric Usability and Benefit Investigation (NCT NCT05055453)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Day 1 of study, repeated on Day 14 of study

Results posted on

2024-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Study Group n=16 Participants 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.
Age, Customized	12 years n=16 Participants
Sex: Female, Male Female	8 Participants n=16 Participants
Sex: Female, Male Male	8 Participants n=16 Participants
Region of Enrollment Germany	16 participants n=16 Participants

PRIMARY outcome

Timeframe: Day 1 of study, repeated on Day 14 of study

Population: All participants who completed the testing for at least one clinic visit.

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

Outcome measures

Outcome measures
Measure	Experimental Study Group n=16 Participants 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.
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
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Experimental Study Group n=15 Participants 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.
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
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
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
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

Adverse Events

Experimental Study Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean Anne Schnittker, Research Audiologist

Sonova

Phone: +41 58 928 01 01

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place