Trial Outcomes & Findings for Fitting Strategy Study (NCT NCT04972162)

NCT ID: NCT04972162

Last Updated: 2025-09-30

Results Overview

The APHAB consists of 24 questions across 4 subscales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness (AV), assessing hearing difficulties in daily situations reported as percentage of problems (0-100%, 100% = highest number of problems). It evaluates hearing aid (HA) benefit by subtracting the reported % of problems with HA from without HA, yielding scores from 0 (no benefit) to 100 (maximum benefit) in each subscale. The study focuses on the communication subscales (EC, BN, RV) and calculates benefit score differences for each subscale after using A) Web-App-fitted and B) standard-of-care-fitted HAs. The difference-of-benefit scores are compared to non-inferiority margins from Cox\&Alexander (Ear\&Hearing 1995). Differences-in-benefit scores range from -100 to 100, with negative scores indicating greater benefit with Web-App-fitted HAs, 0 indicating identical benefit and higher scores indicating greater benefit with standard-of-care fitting.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: 14-17 Days hearing aid wearing time per fitting type
• Results posted on: 2025-09-30

Participant Flow

Participant milestones

Measure	Web-App-fitted Hearing Aid, Then Standard-of-care Fitted Hearing Aid Patients self-fitted the web-app-fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore those in a home-trial for 14 days.	Standard-of-care Fitted Hearing Aid, Then Web-App-fitted Hearing Aid Patients were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they self-fitted the web-app-fitted hearing aids and wore those in a home-trial for 14 days.
First Intervention (14 Days) STARTED	14	14
First Intervention (14 Days) COMPLETED	14	14
First Intervention (14 Days) NOT COMPLETED	0	0
Washout Period (5 Days) STARTED	14	14
Washout Period (5 Days) COMPLETED	13	13
Washout Period (5 Days) NOT COMPLETED	1	1
Second Intervention (14 Days) STARTED	13	13
Second Intervention (14 Days) COMPLETED	13	13
Second Intervention (14 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Web-App-fitted Hearing Aid, Then Standard-of-care Fitted Hearing Aid Patients self-fitted the web-app-fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore those in a home-trial for 14 days.	Standard-of-care Fitted Hearing Aid, Then Web-App-fitted Hearing Aid Patients were fitted by a hearing care professional with the Standard-of-care fitted hearing aids and wore them in a home-trial for 14 days. After a washout period of 5 days, they self-fitted the web-app-fitted hearing aids and wore those in a home-trial for 14 days.
Washout Period (5 Days) Withdrawal by Subject	1	1

Baseline Characteristics

Fitting Strategy Study

Baseline characteristics by cohort

Measure	Study Participants n=28 Participants Baseline measures are only given for the total group of study participants because of the cross-over design (all participants took part in both arms)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 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	26 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	28 participants n=5 Participants
Self-perceived hearing loss	28 Participants n=5 Participants
Prior experience with hearing aids	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 14-17 Days hearing aid wearing time per fitting type

Population: All participants who completed the study visits were included in the efficacy analysis. The intention to treat (ITT) population includes 2 subjects who withdrew from study. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores (change from baseline) was imputed as 0 for each subscale

The APHAB consists of 24 questions across 4 subscales: Ease of Communication (EC), Background Noise (BN), Reverberation (RV), and Aversiveness (AV), assessing hearing difficulties in daily situations reported as percentage of problems (0-100%, 100% = highest number of problems). It evaluates hearing aid (HA) benefit by subtracting the reported % of problems with HA from without HA, yielding scores from 0 (no benefit) to 100 (maximum benefit) in each subscale. The study focuses on the communication subscales (EC, BN, RV) and calculates benefit score differences for each subscale after using A) Web-App-fitted and B) standard-of-care-fitted HAs. The difference-of-benefit scores are compared to non-inferiority margins from Cox&Alexander (Ear&Hearing 1995). Differences-in-benefit scores range from -100 to 100, with negative scores indicating greater benefit with Web-App-fitted HAs, 0 indicating identical benefit and higher scores indicating greater benefit with standard-of-care fitting.

Outcome measures

Measure	Web-App-fitted Hearing Aids n=26 Participants Participants who wore the web-app-fitted hearing aids either the first or last 2 weeks of the study	Standard-of-care-fitted Hearing Aids n=26 Participants Participants who wore the standard-of-care-fitted hearing aids either the first or last 2 weeks of the study
Abbreviated Profile of Hearing Aid Benefit (APHAB) Benefit Ease of Communication	12.7 score on a scale Standard Deviation 19.09	13.18 score on a scale Standard Deviation 13.60
Abbreviated Profile of Hearing Aid Benefit (APHAB) Benefit Background Noise	11.17 score on a scale Standard Deviation 22.98	12.22 score on a scale Standard Deviation 19.94
Abbreviated Profile of Hearing Aid Benefit (APHAB) Benefit Reverberant Room	11.43 score on a scale Standard Deviation 22.32	12.49 score on a scale Standard Deviation 16.76

Adverse Events

Web App Fitted Hearing Aids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard-of-care Fitted Hearing Aids

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

Dr. Veronika Littmann

WSAUDAS

Phone: +4991313080

Email: veronika.littmann@wsa.com

Results disclosure agreements

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