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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150964
• Other study ID #: SRF-379
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 29, 2022

Study information

• Verified date: May 2023
• Source: Sonova AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 29, 2022
• Est. primary completion date: October 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss

• Must use oral mode of communication

• must speak English

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Phonak Audeo hearing aid
receiver in the canal devices with custom earmolds

Locations

Country	Name	City	State
United States	Arizona State University	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Sonova AG	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)
Primary	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.	Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Primary	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.	Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)
Primary	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.	Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Primary	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.	Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)
Primary	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.	2nd appointment (day 14 of study)