NCT05372094

Noise Reduction Preferences in Teenagers and Pre-teens

Completed NA Results posted Last updated 9 January 2024

What this trial tests

NA trial testing Phonak Hearing Aid in Hearing Loss in 18 participants. Completed in 30 September 2023.

Timeline

23 February 2023

Primary endpoint
30 September 2023

30 September 2023

Quick facts

Lead sponsor	Sonova AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	23 February 2023
Primary completion	30 September 2023
Estimated completion	30 September 2023
Sites	1 location across United States

Drugs / interventions tested

• Phonak Hearing Aid

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Sonova AG — full company profile →

Who can join

Adults 10 to 17, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Subjective Rating of Listening Effort Questionnaire Primary · 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.

Subjective rating with NR OFF

Group	Value	95% CI
Experimental	44.73	± 27.54

Subjective rating with NR at custom setting

Group	Value	95% CI
Experimental	44.5	± 27.45

Subjective rating with NR at WEAK

Group	Value	95% CI
Experimental	41.53	± 26.7

Subjective rating with NR at STRONG

Group	Value	95% CI
Experimental	35.86	± 26.91

Speech Reception Threshold Secondary · 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.

SNR50 with NR setting OFF

Group	Value	95% CI
Experimental	1.01	0.92 – 1.13

SNR50 with NR setting WEAK

Group	Value	95% CI
Experimental	1.02	0.95 – 1.17

SNR50 with NR setting MODERATE

Group	Value	95% CI
Experimental	1.02	0.95 – 1.14

SNR50 with NR setting at STRONG

Group	Value	95% CI
Experimental	1.02	0.94 – 1.17

Physical Response Time Secondary · 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.

Response time with NR OFF

Group	Value	95% CI
Experimental	2452.65	± 561.43

Response time with NR WEAK

Group	Value	95% CI
Experimental	2432.16	± 509.75

Response time with NR STRONG

Group	Value	95% CI
Experimental	2388.25	± 468.62

Response time with NR at a custom setting

Group	Value	95% CI
Experimental	2367.7	± 448.7

Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings Secondary · 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 o

Preferred NR off

Group	Value	95% CI
Experimental	1

Preferred NR at individual preferred setting

Group	Value	95% CI
Experimental	5

Preferred OFF and preferred setting the same

Group	Value	95% CI
Experimental	9

Subjective Questionnaire on Preference for Accessing Bluetooth on Phone Secondary · 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.

Prefer tapping to access streaming over using phone controls or hearing aid button

Group	Value	95% CI
Experimental	10

Prefer tapping to answer phone call over using phone or hearing aid button

Group	Value	95% CI
Experimental	8

Prefer tapping to access voice assistant over using phone control or hearing aid button

Group	Value	95% CI
Experimental	6

Verbal Response Accuracy Secondary · 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.

Noise Reduction setting OFF

Group	Value	95% CI
Experimental	14.37	7.5 – 18

Noise Reduction setting WEAK

Group	Value	95% CI
Experimental	14.17	8 – 19

Noise Reduction setting STRONG

Group	Value	95% CI
Experimental	13.93	6 – 18

NR setting CUSTOM

Group	Value	95% CI
Experimental	14.3	7.5 – 18

Sponsor's own description

Noise reduction preferences and blue tooth access to hearing aid streaming features will be evaluated in experienced hearing aid users age 10-17.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.