Noise Reduction Preferences in Teenagers and Pre-teens

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

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Phonak Hearing Aid

Detailed 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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• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants will be fit with a commercially available hearing aid and tested using various strengths of the noise reduction feature.	Device: Phonak Hearing Aid; Commercially available hearing aid with various noise reduction strengths

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sonova AG
• Collaborators: Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 11, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: SRF-802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes