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Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users

Primary Purpose

Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phonak Audeo hearing aid
Sponsored by
Sonova AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hearing Loss

Eligibility Criteria

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

Inclusion Criteria:

  • clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
  • Must use oral mode of communication
  • must speak English

Exclusion Criteria:

-

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

One group will be fit with commercially available hearing aids that will have different program settings

Outcomes

Primary Outcome Measures

Speech Reception Threshold
A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.
Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.
Multi-word Recognition at 40 dB SPL and 70 dB SPL
Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.
Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.
Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.
Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
May 18, 2023
Sponsor
Sonova AG
Collaborators
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT05150964
Brief Title
Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users
Official Title
Measuring Comfort and Clarity Using Low Gain Feature in Pediatric Hearing Aid Users
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
May 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sonova AG
Collaborators
Arizona State 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

5. Study Description

Brief Summary
Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.

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
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
One group will be fit with commercially available hearing aids that will have different program settings
Intervention Type
Device
Intervention Name(s)
Phonak Audeo hearing aid
Intervention Description
receiver in the canal devices with custom earmolds
Primary Outcome Measure Information:
Title
Speech Reception Threshold
Description
A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.
Time Frame
Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)
Title
Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.
Description
Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.
Time Frame
Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Title
Multi-word Recognition at 40 dB SPL and 70 dB SPL
Description
Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.
Time Frame
Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)
Title
Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.
Description
A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.
Time Frame
Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Title
Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.
Description
A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.
Time Frame
Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Title
Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula
Description
Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.
Time Frame
2nd appointment (day 14 of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss Must use oral mode of communication must speak English Exclusion Criteria: -
Facility Information:
Facility Name
Arizona State University
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States

12. IPD Sharing Statement

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Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users

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