Trial Outcomes & Findings for Noise Reduction Preferences in Teenagers and Pre-teens (NCT NCT05372094)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

Day 14 of study, visit 2

Results posted on

2024-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	18
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	0

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 n=18 Participants 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
Age, Continuous	14.33 years n=18 Participants
Sex: Female, Male Female	9 Participants n=18 Participants
Sex: Female, Male Male	9 Participants n=18 Participants
Region of Enrollment United States	18 Participants n=18 Participants

PRIMARY outcome

Timeframe: 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)

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.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants 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
Subjective Rating of Listening Effort Questionnaire Subjective rating with NR OFF	44.73 units on a scale Standard Deviation 27.54
Subjective Rating of Listening Effort Questionnaire Subjective rating with NR at custom setting	44.5 units on a scale Standard Deviation 27.45
Subjective Rating of Listening Effort Questionnaire Subjective rating with NR at WEAK	41.53 units on a scale Standard Deviation 26.7
Subjective Rating of Listening Effort Questionnaire Subjective rating with NR at STRONG	35.86 units on a scale Standard Deviation 26.91

SECONDARY outcome

Timeframe: Day 28, visit 3

Population: All participants who completed the task except three identified outliers.

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.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants 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
Speech Reception Threshold SNR50 with NR setting OFF	1.01 decibels (dB) Interval 0.92 to 1.13
Speech Reception Threshold SNR50 with NR setting WEAK	1.02 decibels (dB) Interval 0.95 to 1.17
Speech Reception Threshold SNR50 with NR setting MODERATE	1.02 decibels (dB) Interval 0.95 to 1.14
Speech Reception Threshold SNR50 with NR setting at STRONG	1.02 decibels (dB) Interval 0.94 to 1.17

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Experimental n=14 Participants 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
Physical Response Time Response time with NR at a custom setting	2367.7 milliseconds Standard Deviation 448.7
Physical Response Time Response time with NR OFF	2452.65 milliseconds Standard Deviation 561.43
Physical Response Time Response time with NR WEAK	2432.16 milliseconds Standard Deviation 509.75
Physical Response Time Response time with NR STRONG	2388.25 milliseconds Standard Deviation 468.62

SECONDARY outcome

Timeframe: Day 1 of study, visit 1

Population: All participants who completed the task excluding three identified outliers who were excluded from all analyses.

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.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants 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
Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings Preferred NR at individual preferred setting	5 Participants
Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings Preferred NR off	1 Participants
Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings Preferred OFF and preferred setting the same	9 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Experimental n=14 Participants 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
Subjective Questionnaire on Preference for Accessing Bluetooth on Phone Prefer tapping to access streaming over using phone controls or hearing aid button	10 Participants
Subjective Questionnaire on Preference for Accessing Bluetooth on Phone Prefer tapping to answer phone call over using phone or hearing aid button	8 Participants
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

SECONDARY outcome

Timeframe: Day 14 of study, visit 2

Population: All participants who completed the task excluding three identified outliers who were excluded from all analyses.

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.

Outcome measures

Outcome measures
Measure	Experimental n=15 Participants 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
Verbal Response Accuracy Noise Reduction setting OFF	14.37 words repeated correctly Interval 7.5 to 18.0
Verbal Response Accuracy Noise Reduction setting WEAK	14.17 words repeated correctly Interval 8.0 to 19.0
Verbal Response Accuracy Noise Reduction setting STRONG	13.93 words repeated correctly Interval 6.0 to 18.0
Verbal Response Accuracy NR setting CUSTOM	14.3 words repeated correctly Interval 7.5 to 18.0

Adverse Events

Experimental

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

Director of Research

Sonova US

Phone: 630-821-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place