Trial Outcomes & Findings for Direct-to-Consumer Hearing Aids and Listening Effort (NCT NCT05855005)

Results Overview

Participant and their communication partner discuss pictures with slight differences and attempt to locate all the differences by discussion alone. Primary measurement is average time for each correctly identified difference. A decrease in time indicates improved efficiency in the task.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Task is completed at first study visit (typically 2 hours) after hearing aid fitting, with and without hearing aids.

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	DTC Hearing Aid DTC Hearing Aids: DTC hearing aid programmed to the individual participant.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTC Hearing Aid n=30 Participants DTC Hearing Aids: DTC hearing aid programmed to the individual participant.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=30 Participants
Age, Categorical >=65 years	21 Participants n=30 Participants
Age, Continuous	68 years STANDARD_DEVIATION 11.3 • n=30 Participants
Sex: Female, Male Female	21 Participants n=30 Participants
Sex: Female, Male Male	9 Participants n=30 Participants
Region of Enrollment United States	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: Task is completed at first study visit (typically 2 hours) after hearing aid fitting, with and without hearing aids.

Participant and their communication partner discuss pictures with slight differences and attempt to locate all the differences by discussion alone. Primary measurement is average time for each correctly identified difference. A decrease in time indicates improved efficiency in the task.

Outcome measures

Outcome measures
Measure	DTC Hearing Aid n=30 Participants DTC Hearing Aids: DTC hearing aid programmed to the individual participant.
Diapix Conversation Task: Average Time Per Correctly Identified Difference Unaided	2.47 Minute Standard Deviation .87
Diapix Conversation Task: Average Time Per Correctly Identified Difference Aided	2.45 Minute Standard Deviation .85

SECONDARY outcome

Timeframe: Task will be completed at second study visit (about one hour). second visit usually takes place 1-2 weeks after first visit.

Participant completes the RRT, a measure of memory and reported listening effort where the listener repeats pre-recorded sentences as they are presented and is then asked to recall them 15 seconds later.

Outcome measures

Outcome measures
Measure	DTC Hearing Aid n=30 Participants DTC Hearing Aids: DTC hearing aid programmed to the individual participant.
Pupillometry and Recall Repeat Task (RRT) Unaided 5 dB SNR Low Context	23 percentage of words recalled Standard Deviation 12.7
Pupillometry and Recall Repeat Task (RRT) Aided (default program per Participant's loss) 5 dB SNR Low Context	18 percentage of words recalled Standard Deviation 11.12
Pupillometry and Recall Repeat Task (RRT) Aided (Noise program) 5 dB SNR Low Context	21 percentage of words recalled Standard Deviation 12.5

Adverse Events

DTC Hearing Aid

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

Kendra Marks

Northwestern University

Phone: 2069991423

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place