Trial Outcomes & Findings for Wear-Time Trial for Self-Fitting Hearing Aid (NCT NCT04823494)
NCT ID: NCT04823494
Last Updated: 2022-05-11
Results Overview
The APHAB is a 24-item self-assessment of the amount of trouble the respondent has with communication in everyday situations. Sample question: "When I'm at the dinner table with several people, and I am trying to have a conversation with one person, understanding speech is difficult." For each of the 24 items, person asked to select one of the following percentages to indicate how frequently this occurs: Always (99%); Almost Always (87%); Generally (75%); Half-the-time (50%); Occasionally (25%); Seldom (12%); or Never (1%). Mean scale scores are expressed as a percentage or proportion representing the average frequency of difficulty experienced. An APHAB global score based on the 18 items from the three speech-communication subscales was used in the statistical analyses. APHAB scores were obtained unaided (Visit 1) and following use of the hearing aids for 10-14 days for each fit (Visits 2 \& 3; aided). The primary outcome is the mean difference in aided scores, Self-Fit minus Pro-Fit.
COMPLETED
NA
40 participants
10-14 days
2022-05-11
Participant Flow
Visit 1 included tests to determine study eligibility and baseline (unaided) performance for outcomes measures obtained after each segment of the crossover field trial (Visits 2 and 3). Eligible subjects were assigned successively to one of two treatment orders at each site for counterbalancing of treatment order. As a result, all 40 enrollees met selection criteria and were assigned to one of the two treatment orders.
Participant milestones
| Measure |
Pro-Fit Followed by Self-Fit
Hearing aids fit by a professional hearing care provider using best practices, followed by a self-fit of both devices. There was a 10-14-day wear period following each fitting method.
Hearing aids: Earbud style hearing aids fit to both ears
|
Self-Fit Followed by Pro-Fit
Hearing aids self-fit by participant followed by the fitting of the devices by a professional hearing care provider using best practices. There was a 10-14-day wear period following each fitting method.
Hearing aids: Earbud style hearing aids fit to both ears
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
19
|
|
Overall Study
COMPLETED
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Pro-Fit Followed by Self-Fit
Hearing aids fit by a professional hearing care provider using best practices, followed by a self-fit of both devices. There was a 10-14-day wear period following each fitting method.
Hearing aids: Earbud style hearing aids fit to both ears
|
Self-Fit Followed by Pro-Fit
Hearing aids self-fit by participant followed by the fitting of the devices by a professional hearing care provider using best practices. There was a 10-14-day wear period following each fitting method.
Hearing aids: Earbud style hearing aids fit to both ears
|
|---|---|---|
|
Overall Study
Programming software malfunction.
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Devices lost
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pro-Fit Followed by Self-Fit
n=19 Participants
Hearing aids initially fit by a professional hearing care provider using best practices and worn for 10-14 days. Devices then self-fit by participant and worn for 10-14 days.
Hearing aids: Earbud style hearing aids fit to both ears
|
Self-Fit Followed by Pro-Fit
n=18 Participants
Hearing aids self-fit by patient initially and worn for 10-14 days. Devices then fit by a professional hearing care provider using best practices and worn for another 10-14 days.
Hearing aids: Earbud style hearing aids fit to both ears
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=37 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=19 Participants
|
8 Participants
n=18 Participants
|
19 Participants
n=37 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=19 Participants
|
10 Participants
n=18 Participants
|
18 Participants
n=37 Participants
|
|
Age, Continuous
|
60.95 years
STANDARD_DEVIATION 8.71 • n=19 Participants
|
58.67 years
STANDARD_DEVIATION 15.11 • n=18 Participants
|
59.84 years
STANDARD_DEVIATION 12.13 • n=37 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=19 Participants
|
9 Participants
n=18 Participants
|
18 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=19 Participants
|
9 Participants
n=18 Participants
|
19 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
18 Participants
n=18 Participants
|
37 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 10-14 daysPopulation: Crossover design. All 37 subjects participated in both Pro-Fit and Self-Fit phases with about half receiving each intervention first. Subjects crossed after 10-14 day field use.
The APHAB is a 24-item self-assessment of the amount of trouble the respondent has with communication in everyday situations. Sample question: "When I'm at the dinner table with several people, and I am trying to have a conversation with one person, understanding speech is difficult." For each of the 24 items, person asked to select one of the following percentages to indicate how frequently this occurs: Always (99%); Almost Always (87%); Generally (75%); Half-the-time (50%); Occasionally (25%); Seldom (12%); or Never (1%). Mean scale scores are expressed as a percentage or proportion representing the average frequency of difficulty experienced. An APHAB global score based on the 18 items from the three speech-communication subscales was used in the statistical analyses. APHAB scores were obtained unaided (Visit 1) and following use of the hearing aids for 10-14 days for each fit (Visits 2 \& 3; aided). The primary outcome is the mean difference in aided scores, Self-Fit minus Pro-Fit.
Outcome measures
| Measure |
Pro-Fit
n=37 Participants
Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days prior to outcomes measurement.
Hearing aids: Earbud style hearing aids fit to both ears
|
Self-Fit
n=37 Participants
Hearing aids self-fit by participant and worn 10-14 days prior to outcomes measurement.
Hearing aids: Earbud style hearing aids fit to both ears
|
|---|---|---|
|
Aided Abbreviated Profile of Hearing Aid Benefit (APHAB)
|
21.35 score on a scale
Interval 16.78 to 26.33
|
22.76 score on a scale
Interval 18.33 to 27.59
|
SECONDARY outcome
Timeframe: Measurement after 10-14-day wear time for each fit.Population: Crossover design. All 37 subjects participated in both Pro-Fit and Self-Fit phases. Subjects crossed after 10-14 day field use.
The QuickSIN test consists of lists of six sentences played from a loudspeaker at a constant level approximating typical conversation. The level of the co-located four-talker babble (background noise) increased across the six sentences for signal-to-noise ratios (SNRs) ranging from +25 to 0 decibels (dB) SNR (in steps of 5 dB). The participant was asked to repeat each sentence. The examiner scored predetermined key words in each sentence. The resulting score was interpreted as an SNR loss in dB where a value near 0 dB indicates normal hearing and larger values indicate more difficulty listening in noise. The QuickSIN SNR values for the Pro-Fit condition were subtracted from those for the Self-Fit condition to generate a difference value in dB between the two fitting methods. The secondary outcome measure evaluated here was the mean difference in QuickSIN SNR values in dB between Pro-Fit and Self-Fit for all 37 participants; 19 Pro-Fit first and 18 Self-Fit first.
Outcome measures
| Measure |
Pro-Fit
n=37 Participants
Hearing aids fit by a professional hearing care provider using best practices and worn for 10-14 days prior to outcomes measurement.
Hearing aids: Earbud style hearing aids fit to both ears
|
Self-Fit
n=37 Participants
Hearing aids self-fit by participant and worn 10-14 days prior to outcomes measurement.
Hearing aids: Earbud style hearing aids fit to both ears
|
|---|---|---|
|
Quick Speech in Noise Test (QuickSIN)
|
2.19 score on a scale (dB)
Interval 1.53 to 2.89
|
2.77 score on a scale (dB)
Interval 2.18 to 3.37
|
Adverse Events
Pro-Fit
Self-Fit
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place