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Noise Reduction Preferences in Teenagers and Pre-teens

Primary Purpose

Hearing Loss

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonak Hearing Aid
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

10 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phonak Hearing Aid

Arm Description

The study hearing aid is commercially available Receiver-in-Canal model.

Outcomes

Primary Outcome Measures

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

speech reception threshold
signal to noise ratio in which participant can correctly repeat 50% of key words at different levels of noise reduction
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.
subjective preference questionnaire for hearing aid noise reduction settings
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.

Full Information

First Posted
May 3, 2022
Last Updated
February 1, 2023
Sponsor
Sonova AG
Collaborators
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT05372094
Brief Title
Noise Reduction Preferences in Teenagers and Pre-teens
Official Title
Noise Reduction Preferences in Teenagers and Pre-teens
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Vanderbilt University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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). .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Masking Description
Participants will be blinded during objective testing and subjective preference rating for noise reduction settings.
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phonak Hearing Aid
Arm Type
Experimental
Arm Description
The study hearing aid is commercially available Receiver-in-Canal model.
Intervention Type
Device
Intervention Name(s)
Phonak Hearing Aid
Intervention Description
Commercially available hearing aid
Primary Outcome Measure Information:
Title
verbal response accuracy
Description
percent correct of monosyllabic words presented in noise at different levels of noise reduction, while also performing a visual task
Time Frame
Day 14 of study, visit 2
Title
verbal response time
Description
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
Time Frame
Day 14 of study, visit 2
Title
subjective rating of listening effort questionnaire
Description
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.
Time Frame
Day 14 of study, visit 2
Secondary Outcome Measure Information:
Title
speech reception threshold
Description
signal to noise ratio in which participant can correctly repeat 50% of key words at different levels of noise reduction
Time Frame
Day 28, visit 3
Title
subjective questionnaire on preference for accessing bluetooth on phone
Description
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.
Time Frame
Day 28, visit 3
Title
subjective preference questionnaire for hearing aid noise reduction settings
Description
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.
Time Frame
Day 1 of study, visit 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data will be shared with other researchers.

Learn more about this trial

Noise Reduction Preferences in Teenagers and Pre-teens

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