Noise Reduction Preferences in Teenagers and Pre-teens

Hearing Loss Clinical Trial

Official title:

Noise Reduction Preferences in Teenagers and Pre-teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372094
• Other study ID #: SRF-802
• Status: Completed
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2024
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The purpose of this study is to evaluate the preferences for hearing aid noise reduction settings in users age 10 -17, as well as to evaluate preferences for accessing the hearing aid Bluetooth streaming programs for this population. Subjective preferences will be obtained by having the participants listen to a noisy scene with different levels of noise reduction, to which they are blinded, and rate their preference. Blinded objective speech performance testing will be completed by a) finding the signal-to-noise ratio at which participant can correctly repeat back 50% of the target words, and b) measuring the percent of words correctly repeated during a noisy listening task. These tasks will be done using different levels of noise reduction. Subjective preferences for accessing Bluetooth streaming will also be obtained by asking participants which method they prefer (phone, hearing aid, or touch control).

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• mild, moderate, or moderate-severe bilateral sensorineural hearing loss

• native English speakers with ability to communicate verbally

• able to read and follow directions

• access to smartphone and willing to download a hearing aid app

• experienced hearing aid user (6+ months)

Exclusion Criteria:

• unable to follow verbal directions

• unable to communicate verbally

• unable to wear study devices for required home trials

• active middle ear infection

• unable to attend lab visits required for study

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Phonak Hearing Aid
Commercially available hearing aid with various noise reduction strengths

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Rating of Listening Effort Questionnaire	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.	Day 14 of study, visit 2
Secondary	Speech Reception Threshold	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.	Day 28, visit 3
Secondary	Physical Response Time	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.	Day 14 of study, visit 2
Secondary	Subjective Preference Questionnaire for Hearing Aid Noise Reduction Settings	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.	Day 1 of study, visit 1
Secondary	Subjective Questionnaire on Preference for Accessing Bluetooth on Phone	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.	Day 28, visit 3
Secondary	Verbal Response Accuracy	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.	Day 14 of study, visit 2