Noise Reduction Preferences in Teenagers and Pre-teens

• Sponsor: Sonova AG (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05372094
• Collaborator: Vanderbilt University (Other)
• Enrollment: 30
• Arm: 1
• Anticipated Duration (Months): 7.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss	Device: Phonak Hearing Aid	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All participants will be fit with hearing aids with the same noise reduction feature. This feature has distinct, discrete levels of noise reduction which will be evaluated by the participants.All participants will be fit with hearing aids with the same noise reduction feature. This feature has distinct, discrete levels of noise reduction which will be evaluated by the participants.
• Masking: None (Open Label)
• Masking Description: Participants will be blinded during objective testing and subjective preference rating for noise reduction settings.
• Primary Purpose: Treatment
• Official Title: Noise Reduction Preferences in Teenagers and Pre-teens
• Anticipated Study Start Date: May 30, 2022
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Phonak Hearing Aid The study hearing aid is commercially available and the model will be determined by participant's hearing loss. In other words, if participant has a severe hearing loss, they will be fit with a Behind-the-Ear model, and if they have a mild to moderate hearing loss, they will be fit with a Receiver-in-Canal model. Both models of hearing aids have the same features and are considered in the same product family/portfolio. The main differences are the amount of gain available and the cosmetics of the design.

Device: Phonak Hearing Aid; Commercially available hearing aid

Outcome Measures

Primary Outcome Measures

1. verbal response accuracy [Day 14 of study, visit 2]

   percent correct of monosyllabic words presented in noise at different levels of noise reduction, while also performing a visual task

2. verbal response time [Day 14 of study, visit 2]

   length of time it takes participant to respond verbally to monosyllabic words presented in noise at different levels of noise reduction, while also performing a visual task

3. subjective rating of listening effort questionnaire [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 long the task seemed to take using a sliding scale with 100 increments between two verbal anchors: "it felt fast" to "it took forever". Higher scores indicate higher perceived listening effort.

Secondary Outcome Measures

1. speech reception threshold [Day 28, visit 3]

   signal to noise ratio in which participant can correctly repeat 50% of key words at different levels of noise reduction

2. subjective questionnaire on preference for accessing bluetooth on phone [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.

3. subjective preference questionnaire for hearing aid noise reduction settings [Day 1 of study, visit 1]

   blinded paired comparison between two different settings of noise reduction, while listening to a story presented in noise. Participants will 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sonova AG
• Vanderbilt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sonova AG
• ClinicalTrials.gov Identifier: NCT05372094
• Other Study ID Numbers: SRF-802
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Hearing Loss

Study Results

No Results Posted as of May 12, 2022