Trial Outcomes & Findings for Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes (NCT NCT03579563)

Last Updated: 2024-10-10

Results Overview

The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using smartphone-based Ecological Momentary Assessment (EMA) to collect in-situ reports. Scores from the items that evaluate patient's HA use are averaged across the four situations to form the EMA-GHABP-Use score. The score ranges from 1 (not use HA at all) to 5 (use HA all the time).

Recruitment status

COMPLETED

Study phase

Target enrollment

290 participants

Primary outcome timeframe

7-weeks post-intervention

Results posted on

2024-10-10

Participant Flow

Participants were recruited between February 2019 and December 2023. Participants were recruited from the an established participant registry and through mass emails to the communities around Iowa City, IA and Vanderbilt, TN.

Participant milestones

Participant milestones
Measure	AUD/High-end In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Overall Study STARTED	49	45	52	45	46	53
Overall Study COMPLETED	43	41	42	40	39	40
Overall Study NOT COMPLETED	6	4	10	5	7	13

Reasons for withdrawal

Reasons for withdrawal
Measure	AUD/High-end In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Overall Study Lost to Follow-up	0	0	0	0	1	0
Overall Study Lack of Efficacy	1	1	4	1	2	3
Overall Study Health concern (unrelated to the intervention of the study)	2	0	0	1	2	2
Overall Study Time/distance concern	0	0	1	0	0	1
Overall Study COVID shutdown	2	3	4	3	1	2
Overall Study Protocol administration error	1	0	1	0	1	5

Baseline Characteristics

Impact of Hearing Aid Service-delivery Model and Technology on Patient Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.	Total n=245 Participants Total of all reporting groups
Age, Continuous	66.3 years STANDARD_DEVIATION 7.1 • n=5 Participants	66.7 years STANDARD_DEVIATION 12.4 • n=7 Participants	67.6 years STANDARD_DEVIATION 7.4 • n=5 Participants	67.5 years STANDARD_DEVIATION 6 • n=4 Participants	68.9 years STANDARD_DEVIATION 7.3 • n=21 Participants	69.5 years STANDARD_DEVIATION 6.8 • n=8 Participants	67.7 years STANDARD_DEVIATION 8.1 • n=8 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	20 Participants n=7 Participants	22 Participants n=5 Participants	19 Participants n=4 Participants	17 Participants n=21 Participants	21 Participants n=8 Participants	121 Participants n=8 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	21 Participants n=4 Participants	22 Participants n=21 Participants	19 Participants n=8 Participants	124 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	41 Participants n=5 Participants	39 Participants n=7 Participants	41 Participants n=5 Participants	40 Participants n=4 Participants	39 Participants n=21 Participants	40 Participants n=8 Participants	240 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	38 Participants n=7 Participants	42 Participants n=5 Participants	39 Participants n=4 Participants	37 Participants n=21 Participants	37 Participants n=8 Participants	234 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Hearing loss (pure-tone average)	31.2 dB HL STANDARD_DEVIATION 7.9 • n=5 Participants	31.8 dB HL STANDARD_DEVIATION 7.8 • n=7 Participants	30.1 dB HL STANDARD_DEVIATION 6.8 • n=5 Participants	31.5 dB HL STANDARD_DEVIATION 8.1 • n=4 Participants	30.6 dB HL STANDARD_DEVIATION 7.3 • n=21 Participants	31 dB HL STANDARD_DEVIATION 7.2 • n=8 Participants	31 dB HL STANDARD_DEVIATION 7.5 • n=8 Participants

PRIMARY outcome

Timeframe: 7-weeks post-intervention

Outcome measures

Outcome measures
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Hearing Aid Use Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Use)	4.4 score on a scale Standard Deviation 1.4	4.1 score on a scale Standard Deviation 1.6	3.8 score on a scale Standard Deviation 1.8	4.5 score on a scale Standard Deviation 1.2	3.8 score on a scale Standard Deviation 1.7	4.3 score on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 7-weeks post-intervention

The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using smartphone-based Ecological Momentary Assessment (EMA) to collect in-situ reports. Scores from the items that evaluate a patient's hearing disability, hearing handicap, HA benefit, and HA satisfaction are averaged across the four situations to form the EMA-GHABP-Global score. The score ranges from 1 (poorer outcome) to 5 (better outcome).

Outcome measures

Outcome measures
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Hearing Aid Benefit Measured Using In-situ Glasgow Hearing Aid Benefit Profile (EMA-GHABP-Global)	4.1 score on a scale Standard Deviation .5	3.9 score on a scale Standard Deviation 0.6	3.9 score on a scale Standard Deviation 0.6	4.1 score on a scale Standard Deviation 0.5	3.8 score on a scale Standard Deviation 0.6	3.9 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: pre-intervention and 7 weeks post-intervention

The PHAP is a questionnaire designed to measures the performance of hearing aids in speech communication. The score ranges from 1 (good performance) to 99 (poor performance) (i.e., lower scores mean better performance). Participants will complete this questionnaire pre-intervention and at 7 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -98 (indicating a benefit from hearing aids) to +98 (indicating a detrimental effect of hearing aids).

Outcome measures

Outcome measures
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Change of Hearing Aid Performance Measured Using the Profile of Hearing Aid Performance (PHAP)	-17.7 score on a scale Standard Deviation 20.1	-14.2 score on a scale Standard Deviation 11.2	-15.2 score on a scale Standard Deviation 19.7	-16.1 score on a scale Standard Deviation 12.3	-13.4 score on a scale Standard Deviation 14.2	-13.6 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: pre-intervention and 6 weeks post-intervention

The CST is a speech recognition test designed to simulate daily speech communication. The score ranges from 0 (understand no speech) to 100 (understand all speech). Participants will complete this questionnaire pre-intervention and at 6 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -100 (indicating a detrimental effect of hearing aids) to +100 (indicating a benefit from hearing aids).

Outcome measures

Outcome measures
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Change of Speech Recognition Performance as Measured by the Connected Speech Test (CST)	10.5 percentage of correct response Standard Deviation 15.7	5 percentage of correct response Standard Deviation 12.4	6.7 percentage of correct response Standard Deviation 11.6	4.6 percentage of correct response Standard Deviation 10.7	2.2 percentage of correct response Standard Deviation 12.9	6.4 percentage of correct response Standard Deviation 19.7

SECONDARY outcome

Timeframe: pre-intervention and 7 weeks post-intervention

The HHIE and HHIA are questionnaires designed to measure subject's perceived hearing handicap. For subjects order and younger 65 years old, the HHIE and HHIA will be used, respectively. The score ranges from 0 (no handicap) to 100 (more handicap) (i.e., lower scores mean less handicap). Participants will complete this questionnaire pre-intervention and at 7 weeks post-intervention. The change in scores between pre- and post-intervention will be used for analysis, with score changes ranging from -100 (indicating a benefit from hearing aids) to +100 (indicating a detrimental effect of hearing aids).

Outcome measures

Outcome measures
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Change of Hearing Handicap Measured by Hearing Handicap Inventory for the Elderly (HHIE) or Hearing Handicap Inventory for Adults (HHIA)	-23.3 score on a scale Standard Deviation 24.6	-13.7 score on a scale Standard Deviation 16.6	-15 score on a scale Standard Deviation 14.8	-17.7 score on a scale Standard Deviation 14.9	-14 score on a scale Standard Deviation 18.6	-13 score on a scale Standard Deviation 17.4

SECONDARY outcome

Timeframe: 6-week post-intervention

The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using retrospective questionnaires. Scores from the items that evaluate patient's HA use are averaged across the four situations to form the Retro-GHABP-Use score. The score ranges from 1 (not use HA at all) to 5 (use HA all the time).

Outcome measures

Outcome measures
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Hearing Aid Use Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Use)	4.3 score on a scale Standard Deviation 0.9	3.9 score on a scale Standard Deviation 1	3.5 score on a scale Standard Deviation 1.2	4.2 score on a scale Standard Deviation 0.8	3.4 score on a scale Standard Deviation 1.1	4 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 6 weeks post-intervention

The GHABP is a questionnaire that measures hearing aid (HA) users' listening experience in four situations: TV listening, small conversation in quiet, conversation in noise, and group conversation. The GHABP will be administered using retrospective questionnaires. Scores from the items that evaluate a patient's hearing disability, hearing handicap, HA benefit, and HA satisfaction are averaged across the four situations to form the Retro-GHABP-Global score. The score ranges from 1 (poorer outcome) to 5 (better outcome).

Outcome measures

Outcome measures
Measure	AUD/High-end n=43 Participants In this group, the audiologist-based fitting will be used to provide high-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. High-end HA: High-end hearing aids will be used.	OTC+/High-end n=41 Participants In this group, audiologists will provide brief services to fit high-end OTC hearing aids OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. High-end HA: High-end hearing aids will be used.	OTC/High-end n=42 Participants In this group, high-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. High-end HA: High-end hearing aids will be used.	AUD/Low-end n=40 Participants In this group, the audiologist-based fitting will be used to provide low-end hearing aids. AUD fitting: Prescription hearing aids will be fitted by audiologists using established procedures. Low-end HA: Low-end hearing aids will be used.	OTC+/Low-end n=39 Participants In this group, audiologists will provide brief services to fit low-end OTC hearing aids. OTC+ fitting: Audiology professionals provide brief services to fit preset-based OTC hearing aids, which are simulated using prescription hearing aids. Low-end HA: Low-end hearing aids will be used.	OTC/Low-end n=40 Participants In this group, low-end OTC hearing aids will be provided to subjects. OTC fitting: In this group, preset-based OTC hearing aids, which are simulated using prescription hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids. Low-end HA: Low-end hearing aids will be used.
Hearing Aid Benefit Measured Using Retrospective Glasgow Hearing Aid Benefit Profile (Retro-GHABP-Global)	3.9 score on a scale Standard Deviation 0.5	3.7 score on a scale Standard Deviation 0.5	3.7 score on a scale Standard Deviation 0.5	3.9 score on a scale Standard Deviation 0.5	3.5 score on a scale Standard Deviation 0.7	3.7 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 7-week post-intervention

The SADL is a questionnaire designed to measures subject's perceived hearing aid satisfaction. The score ranges from 1 (low satisfaction) to 7 (high satisfaction).