NCT05150964

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

Completed NA Results posted Last updated 19 May 2023

What this trial tests

NA trial testing Phonak Audeo hearing aid in Hearing Loss in 16 participants. Completed in 29 May 2022.

Timeline

1 June 2021

Primary endpoint
15 October 2021

29 May 2022

Quick facts

Lead sponsor	Sonova AG
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	16
Start date	1 June 2021
Primary completion	15 October 2021
Estimated completion	29 May 2022
Sites	1 location across United States

Drugs / interventions tested

• Phonak Audeo hearing aid

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Sonova AG — full company profile →

Who can join

Adults 8 to 17, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Speech Reception Threshold Primary · Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)

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 partic

NAL Fitting with ASG Off

Group	Value	95% CI
Experimental	27	± 8

NAL Fitting with ASG ON

Group	Value	95% CI
Experimental	27	± 7

DSL Fitting with ASG Off

Group	Value	95% CI
Experimental	24	± 8

DSL Fitting with ASG On

Group	Value	95% CI
Experimental	24	± 6

Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL. Primary · Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

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

% correct at 40 dB, NAL fitting, ASG Off

Group	Value	95% CI
Experimental	52	± 24

% correct at 40 dB, NAL fitting, ASG On

Group	Value	95% CI
Experimental	63	± 26

% correct at 40 dB, DSL fitting, ASG Off

Group	Value	95% CI
Experimental	69	± 21

% correct at 40 dB, DSL fitting, ASG On

Group	Value	95% CI
Experimental	75	± 22

% correct at 70 dB, NAL fitting, ASG Off

Group	Value	95% CI
Experimental	92	± 10

% correct at 70 dB, NAL fitting, ASG On

Group	Value	95% CI
Experimental	95	± 5

% correct at 70 dB, DSL fitting, ASG Off

Group	Value	95% CI
Experimental	95	± 6

% correct, DSL fitting, ASG On

Group	Value	95% CI
Experimental	96	± 7

Multi-word Recognition at 40 dB SPL and 70 dB SPL Primary · Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)

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 highe

% correct at 40 dB for NAL fitting, ASG Off

Group	Value	95% CI
Experimental	48	± 20

% correct at 40 dB for NAL fitting, ASG On

Group	Value	95% CI
Experimental	56	± 16

% correct at 40 dB for DSL fitting, ASG Off

Group	Value	95% CI
Experimental	51	± 16

% correct at 40 dB for DSL fitting, ASG On

Group	Value	95% CI
Experimental	54	± 16

% correct at 70 dB, NAL fitting, ASG Off

Group	Value	95% CI
Experimental	66	± 17

% correct at 70 dB, NAL fitting, ASG On

Group	Value	95% CI
Experimental	67	± 13

% correct at 70 dB, DSL fitting, ASG Off

Group	Value	95% CI
Experimental	63	± 13

% correct at 70 dB, DSL fitting, ASG On

Group	Value	95% CI
Experimental	67	± 13

Nonword Detection Presented at 40 dB SPL and at 70 dB SPL. Primary · Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

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 NA

% correct at 40 dB, NAL fitting formula, ASG Off

Group	Value	95% CI
Experimental	65	± 15

% correct at 40 dB, NAL fitting with ASG On

Group	Value	95% CI
Experimental	68	± 13

% correct at 40 dB, DSL fitting, ASG Off

Group	Value	95% CI
Experimental	73	± 18

% correct at 40 dB, DSL fitting, ASG On

Group	Value	95% CI
Experimental	71	± 12

% correct at 70 dB, NAL fitting, ASG Off

Group	Value	95% CI
Experimental	89	± 7

% correct at 70 dB, NAL fitting, ASG On

Group	Value	95% CI
Experimental	87	± 7

% correct at 70 dB, DSL fitting, ASG Off

Group	Value	95% CI
Experimental	88	± 9

% correct at 70 dB, DSL fitting, ASG On

Group	Value	95% CI
Experimental	87	± 7

Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL. Primary · Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

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

% correct at 40 dB, NAL fitting, ASG Off

Group	Value	95% CI
Experimental	68	± 23

% correct at 40 dB, NAL fitting, ASG On

Group	Value	95% CI
Experimental	76	± 18

% correct at 40 dB, DSL fitting, ASG Off

Group	Value	95% CI
Experimental	70	± 22

% correct at 40 dB, DSL fitting, ASG On

Group	Value	95% CI
Experimental	73	± 20

% correct at 70 dB, NAL fitting, ASG Off

Group	Value	95% CI
Experimental	69	± 18

% correct at 70 dB, NAL fitting, ASG On

Group	Value	95% CI
Experimental	73	± 16

% correct at 70 dB, DSL fitting, ASG Off

Group	Value	95% CI
Experimental	67	± 20

% correct at 70 dB, DSL fitting, ASG On

Group	Value	95% CI
Experimental	70	± 21

Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula Primary · 2nd appointment (day 14 of study)

Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.

Number of participants preferring ASG Off with NAL fitting

Group	Value	95% CI
Experimental	2

Number of participants preferring ASG On with NAL fitting

Group	Value	95% CI
Experimental	2

Number of participants preferring ASG Off with DSL fitting

Group	Value	95% CI
Experimental	7

Number of participants preferring ASG On with DSL fitting

Group	Value	95% CI
Experimental	3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Task-Dependent Effects of Signal Audibility for Processing Speech: Comparing Performance With NAL-NL2 and DSL v5 Hearing Aid Prescriptions at Threshold and at Suprathreshold Levels in 9- to 17-Year-Olds With Hearing Loss.
   Pittman AL, Stewart EC. · · 2023 · cited 2× · PMID 37254534 · DOI 10.1177/23312165231177509