Trial Outcomes & Findings for Hearing Aid Processing and Working Memory in Realistic Spatial Conditions (NCT NCT04521166)

NCT ID: NCT04521166

Last Updated: 2025-09-15

Results Overview

Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (\~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 42 participants
• Primary outcome timeframe: ~20 mins for each intervention over the course of 1-2 days
• Results posted on: 2025-09-15

Participant Flow

Participants were recruited from the local community in the Chicago area

Participant milestones

Measure	Hearing Aid Setting: Single Arm All participants listened to hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, slow-acting compression, and fast-acting compression Hearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
Sub-study 1 STARTED	21
Sub-study 1 COMPLETED	21
Sub-study 1 NOT COMPLETED	0
Sub-study 2 STARTED	23
Sub-study 2 COMPLETED	23
Sub-study 2 NOT COMPLETED	0
Sub-study 3 STARTED	17
Sub-study 3 COMPLETED	17
Sub-study 3 NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hearing Aid Processing and Working Memory in Realistic Spatial Conditions

Baseline characteristics by cohort

Measure	Hearing Aid Setting n=42 Participants Hearing aid features presented in this arm include omnidirectional microphone settings, directional microphone settings, fast-acting compression, and slow-acting compression Hearing aid: Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
Age, Continuous	72.76 years STANDARD_DEVIATION 7.32 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants
Decibel Hearing Level	38.38 Decibel Hearing Level STANDARD_DEVIATION 9.67 • n=5 Participants
Working Memory Capacity: Percentage of words recalled correctly	44.16 Percentage STANDARD_DEVIATION 11.35 • n=5 Participants

PRIMARY outcome

Timeframe: ~20 mins for each intervention over the course of 1-2 days

Population: A total of 42 participants were tested for the study. The study design was a full factorial design where each participant completed the outcome measures with all 4 settings in sub-studies 1 \& 2. In Sub-study 3, the outcome measures were completed with Settings 1 \& 3 only. Due to an error in assigning settings, 1 participant each did not listen with settings 1 \& 3 in sub-study 1; 1 participant did not listen with Setting 3 in sub-study 3.

Listeners will listen to and repeat recorded low-context sentences mixed with noise from different spatial locations. Speech intelligibility will be measured immediately following hearing aid fitting. Scoring is determined by percentage of words repeated correctly. Scores range from 0-100% (higher score indicates better performance). This task may take up to 1-2 visits (~ 2 hours each) for different combinations of hearing aid features. The device will only be worn in the laboratory for the duration of the experimental task and will be retrieved by the investigator at the end of each visit.

Outcome measures

Measure	Setting 1 n=61 Data Points Hearing aid features presented in this arm include omnidirectional microphone settings and fast-acting compression	Setting 2 n=43 Data Points Hearing aid features presented in this arm include omnidirectional microphone settings and slow-acting compression	Setting 3 n=59 Data Points Hearing aid features presented in this arm include directional microphone settings and fast-acting compression	Setting 4 n=44 Data Points Hearing aid features presented in this arm include directional microphone settings and slow-acting compression
Speech Intelligibility (Percent Correct Scores)	0.55 percentage of words correct Interval 0.52 to 0.57	0.59 percentage of words correct Interval 0.56 to 0.62	0.70 percentage of words correct Interval 0.67 to 0.73	0.80 percentage of words correct Interval 0.78 to 0.82

Adverse Events

Hearing Aid Setting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Varsha Rallapalli

Northwestern University

Phone: 847-467-0897

Email: varsha8904@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place