Trial Outcomes & Findings for AutoFocus360 Sound Quality Preference and Claims Study (NCT NCT07224919)
NCT ID: NCT07224919
Last Updated: 2026-08-10
Results Overview
Participants will complete an A-B paired-comparison listening task to assess subjective preference for noise disturbance between two hearing aid conditions. In other words, participants will be asked "which sample has less disturbing noise". During testing, participants will listen to short audio recordings that vary in talker location and noise type. For each trial, participants will indicate which of the two recordings (A or B) has less bothersome background noise. The outcome measure will be the the percentage of "A preferred" versus "B preferred" responses aggregated across all trials and participants for a given noise and talker location. In other words, for a single noise x talker location combination, the outcome measures for AF360 and FWD should add up to 100. Binary preference data will be analyzed using inferential statistics.
COMPLETED
NA
30 participants
During a single 2-hour onsite study session
2026-08-10
Participant Flow
Participant milestones
| Measure |
Participant Group
Participants will listen to scenes of a talker speaking in two types of noise from either the front, left, rear, and right using AutoFocus360 and fixed directional microphones. Condition order is randomized between participants and masked from participants and experimenters.
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|---|---|
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Overall Study
STARTED
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30
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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10
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Reasons for withdrawal
| Measure |
Participant Group
Participants will listen to scenes of a talker speaking in two types of noise from either the front, left, rear, and right using AutoFocus360 and fixed directional microphones. Condition order is randomized between participants and masked from participants and experimenters.
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|---|---|
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Overall Study
Completed earlier version of protocol
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10
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Participant Group
n=20 Participants
Participants will listen to scenes of a talker speaking in two types of noise from either the front, left, rear, and right using AutoFocus360 and fixed directional microphones. Condition order is randomized between participants and masked from participants and experimenters.
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|---|---|
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Age, Continuous
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71.4 Years
STANDARD_DEVIATION 7.7 • n=20 Participants
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Sex: Female, Male
Female
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12 Participants
n=20 Participants
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Sex: Female, Male
Male
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8 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: During a single 2-hour onsite study sessionParticipants will complete an A-B paired-comparison listening task to assess subjective preference for noise disturbance between two hearing aid conditions. In other words, participants will be asked "which sample has less disturbing noise". During testing, participants will listen to short audio recordings that vary in talker location and noise type. For each trial, participants will indicate which of the two recordings (A or B) has less bothersome background noise. The outcome measure will be the the percentage of "A preferred" versus "B preferred" responses aggregated across all trials and participants for a given noise and talker location. In other words, for a single noise x talker location combination, the outcome measures for AF360 and FWD should add up to 100. Binary preference data will be analyzed using inferential statistics.
Outcome measures
| Measure |
Participant Group
n=20 Participants
Participants will listen to scenes of a talker speaking in two types of noise from either the front, left, rear, and right using AutoFocus360 and fixed directional microphones. Condition order is randomized between participants and masked from participants and experimenters.
|
|---|---|
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Noise Disturbance Sound Quality Attribute
Noise 1; Left target; AF360
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81.5 Percentage of preferences
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Noise Disturbance Sound Quality Attribute
Noise 1; Left target; FWD
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18.5 Percentage of preferences
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Noise Disturbance Sound Quality Attribute
Noise 1; Rear target; AF360
|
98 Percentage of preferences
|
|
Noise Disturbance Sound Quality Attribute
Noise 1; Rear target; FWD
|
2 Percentage of preferences
|
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Noise Disturbance Sound Quality Attribute
Noise 1; Right target; AF360
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80 Percentage of preferences
|
|
Noise Disturbance Sound Quality Attribute
Noise 1; Right target; FWD
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20 Percentage of preferences
|
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Noise Disturbance Sound Quality Attribute
Noise 2; Front target; AF360
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74.5 Percentage of preferences
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Noise Disturbance Sound Quality Attribute
Noise 2; Front target; FWD
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25.5 Percentage of preferences
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Noise Disturbance Sound Quality Attribute
Noise 2; Left target; AF360
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68.5 Percentage of preferences
|
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Noise Disturbance Sound Quality Attribute
Noise 2; Left target; FWD
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31.5 Percentage of preferences
|
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Noise Disturbance Sound Quality Attribute
Noise 2; Rear target; AF360
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80.5 Percentage of preferences
|
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Noise Disturbance Sound Quality Attribute
Noise 2; Right target; AF360
|
70.5 Percentage of preferences
|
|
Noise Disturbance Sound Quality Attribute
Noise 2; Right target; FWD
|
29.5 Percentage of preferences
|
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Noise Disturbance Sound Quality Attribute
Noise 1; Front target; AF360
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96 Percentage of preferences
|
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Noise Disturbance Sound Quality Attribute
Noise 1; Front target; FWD
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4 Percentage of preferences
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Noise Disturbance Sound Quality Attribute
Noise 2; Rear target; FWD
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19.5 Percentage of preferences
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SECONDARY outcome
Timeframe: During a single 2-hour onsite study sessionParticipants will complete an A-B paired-comparison listening task to assess subjective preference for speech clarity between two hearing aid conditions. In other words, participants will be asked "which sample has clearer speech". During testing, participants will listen to short audio recordings that vary in talker location and noise type. For each trial, participants will indicate which of the two recordings (A or B) has clearer speech. The outcome measure will be the proportion of "A preferred" versus "B preferred" responses aggregated across all trials and participants for a given noise and talker location. In other words, for a single noise x talker location combination, the outcome measures for AF360 and FWD should add up to 100. . Binary preference data will be analyzed using inferential statistics.
Outcome measures
| Measure |
Participant Group
n=20 Participants
Participants will listen to scenes of a talker speaking in two types of noise from either the front, left, rear, and right using AutoFocus360 and fixed directional microphones. Condition order is randomized between participants and masked from participants and experimenters.
|
|---|---|
|
Speech Clarity Sound Quality Attribute
Noise 1; Front target; FWD
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28.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 1; Left target; AF360
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41.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 1; Left target; FWD
|
58.5 Percentage of preferences
|
|
Speech Clarity Sound Quality Attribute
Noise 1; Rear target; FWD
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8.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 1; Right target; AF360
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34.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 1; Right target; FWD
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65.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 2; Front target; AF360
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79 Percentage of preferences
|
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Speech Clarity Sound Quality Attribute
Noise 2; Front target; FWD
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21 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 2; Right target; AF360
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51 Percentage of preferences
|
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Speech Clarity Sound Quality Attribute
Noise 2; Right target; FWD
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49 Percentage of preferences
|
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Speech Clarity Sound Quality Attribute
Noise 1; Front target; AF360
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71.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 1; Rear target; AF360
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91.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 2; Left target; AF360
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42.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 2; Left target; FWD
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57.5 Percentage of preferences
|
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Speech Clarity Sound Quality Attribute
Noise 2; Rear target; AF360
|
96.5 Percentage of preferences
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Speech Clarity Sound Quality Attribute
Noise 2; Rear target; FWD
|
3.5 Percentage of preferences
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Adverse Events
Participant Group
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