Hearing Loss, Sensorineural
Conditions
Brief summary
To be conducted with adult participants with mild-to-moderate hearing loss to validate the effectiveness of the Web App fitting strategy. Validation measures participant's perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids.
Detailed description
A prospective, randomized controlled, adaptive design, non-inferiority, pre-market and NSR device study. Completed in 26 adult subjects with mild-to-moderate hearing loss to validate the effectiveness of a Web App fitting strategy. Validation measured subject´s perceived hearing aid benefit when using the Web App fitted hearing aids and when using standard-of-care fitted hearing aids. The adaptive study design began with a cross-over design of the first 12 subjects. At the interim analysis, the possibility of an interaction effect was evaluated as a nuisance parameter. In the absence of an interaction effect, the study was completed in cross-over design. The standard-of-care fitted hearing aids were fitted to National Acoustic Laboratories Nonlinear Version 2 (NAL-NL2) prescriptive targets, verified by probe-mic real-ear measures (REM). The null hypothesis (H0) was that subject´s perceived hearing aids benefit using Web App fitted hearing aids is inferior to perceived benefit using standard-of-care fitted hearing aids, and the alternative hypothesis (Ha) was that subject´s perceived hearing aids benefit using Web App fitted hearing aids is non-inferior to that using standard-of-care fitted hearing aids.
Interventions
DEVICEWeb App Strategy Fitting
Web App Strategy fitting of hearing aids
DEVICEStandard-of-care Fitting
Standard-of-care fitting of hearing aids
Sponsors
University of South Dakota
WSAUD A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
The masking only done at the final visit.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years of age or older, * Self-perceived mild to moderate hearing impairment, * Signed informed consent form (ICF), * Fluent in English listening and reading comprehension, * With or without prior experience with hearing aids. At least four subjects and maximum 30% of the total number of subjects enrolled in this study will have prior hearing aid experience. * Measured audiogram with at least four of the test frequencies 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, and 4000 Hz within fitting range of Web App fitted hearing aid
Exclusion criteria
* Hearing aids do not fit into the person's ears with any of the offered silicone 'Click Sleeves' instant ear tips. * Abnormal conditions: * Severe hearing loss or deafness in at least one ear. * A steep decline in hearing ability within the last 90 days in one or both ears. * Active discharge within the last 90 days. * Dizziness. * A visible deformity of the ear. * Pain, or discomfort in the ear, or significant ear wax accumulation. * Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz Hz, 1,000 Hz, and 2,000 Hz.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abbreviated Profile of Hearing Aid Benefit (APHAB) | 14-17 Days hearing aid wearing time per fitting type | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study 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) | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Washout Period (5 Days) | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 14 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Prior experience with hearing aids | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 26 Participants |
| Region of Enrollment United States | 28 participants |
| Self-perceived hearing loss | 28 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 |
Outcome results
Primary
Abbreviated Profile of Hearing Aid Benefit (APHAB)
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Web-App-fitted Hearing Aids | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Benefit Ease of Communication | 12.7 score on a scale | Standard Deviation 19.09 |
| Web-App-fitted Hearing Aids | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Benefit Background Noise | 11.17 score on a scale | Standard Deviation 22.98 |
| Web-App-fitted Hearing Aids | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Benefit Reverberant Room | 11.43 score on a scale | Standard Deviation 22.32 |
| Standard-of-care-fitted Hearing Aids | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Benefit Reverberant Room | 12.49 score on a scale | Standard Deviation 16.76 |
| Standard-of-care-fitted Hearing Aids | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Benefit Ease of Communication | 13.18 score on a scale | Standard Deviation 13.6 |
| Standard-of-care-fitted Hearing Aids | Abbreviated Profile of Hearing Aid Benefit (APHAB) | Benefit Background Noise | 12.22 score on a scale | Standard Deviation 19.94 |
Comparison: Check for interaction effect for Ease of Communication Subscale (EC)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect.p-value: 0.38ANOVA
Comparison: Check for interaction effect for Background Noise Subscale (BN)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect.p-value: 0.79ANOVA
Comparison: Check for interaction effect for Reverberant Room Subscale (RV)~The statistical analysis method was a repeated-measures ANOVA in which:~* order is a between-subjects effect - i.e., each subject has just one order~* treatment is a within-subjects effect - i.e., each subjects has both treatments because of the cross-over design~* the interaction term treatment x order is a within-subjects effect. The rm-ANOVAs generates a nuisance p-value: that of the interaction effect.p-value: 0.51ANOVA
Comparison: Results for Ease of Communication Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.p-value: <0.000195% CI: [-4.3, 5.2]ANOVA
Comparison: Results for Background Noise Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.p-value: <0.000195% CI: [-5.3, 7.2]ANOVA
Comparison: Results for Reverberant Room Subscale. Null hypothesis: benefit(standard-of-care fit) - benefit(web-app-fit) \< noninferiority margin for all subscales. Each subscale was analyzed using an rm-ANOVA in which the repeated factors are order \& treatment; no between-group factors. Interaction term was order x treatment. ITT population includes 2 subjects who withdrew. It was concluded that their primary endpoint data was missing for cause and their APHAB benefit scores were imputed as 0.p-value: <0.000195% CI: [-4.6, 6.5]ANOVA