Trial Outcomes & Findings for Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss (NCT NCT04739436)

Results Overview

The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 3 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 3 months than at baseline.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

278 participants

Primary outcome timeframe

Baseline, 3 months

Results posted on

2025-04-10

Participant Flow

Two participants were found to be ineligible after randomization, so they are excluded from the number who started the study.

Participant milestones

Participant milestones
Measure	Bilateral Hearing Aid Fitting Group Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Overall Study STARTED	140	136
Overall Study COMPLETED	114	107
Overall Study NOT COMPLETED	26	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Bilateral Hearing Aid Fitting Group Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Overall Study Lost to Follow-up	21	23
Overall Study Withdrawal by Subject	4	6
Overall Study not randomized properly	1	0

Baseline Characteristics

Evaluation of Unilateral vs Bilateral Hearing Aids for the Treatment of Age-related Hearing Loss

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bilateral Hearing Aid Fitting Group n=139 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=136 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Total n=275 Participants Total of all reporting groups
Age, Continuous	71.49 years STANDARD_DEVIATION 7.87 • n=5 Participants	70.34 years STANDARD_DEVIATION 7.87 • n=7 Participants	70.92 years STANDARD_DEVIATION 7.88 • n=5 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	67 Participants n=7 Participants	148 Participants n=5 Participants
Sex: Female, Male Male	58 Participants n=5 Participants	69 Participants n=7 Participants	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=5 Participants	130 Participants n=7 Participants	262 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	134 Participants n=5 Participants	127 Participants n=7 Participants	261 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	139 participants n=5 Participants	136 participants n=7 Participants	275 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months

Population: The APHAB score could not be obtained for 18 individuals (5 in the bilateral group, 13 in the unilateral group); 16 due to missed 3-month follow-up visit; 2 individuals did not complete the APHAB at the 3 month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 3 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 3 months than at baseline.

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=134 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=123 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	-19.74 score on a scale Standard Deviation 15.18	-14.41 score on a scale Standard Deviation 13.02

SECONDARY outcome

Timeframe: 3 months

Population: Outcome measure data missing for 25 individuals at 3 months (9 from bilateral group, 16 from unilateral group). 16 individuals missed the 3-month visit, 8 individuals did not complete the GHABP at the 3-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The GHABP has a categorical response scale with values of 1-5 for each item (4 pre-defined listening situations and up to 4 patient-nominated listening situations). Responses are converted to a 0-100 scale. Higher post-intervention responses are indicative of more benefit for all questions except for "In this situation, with your hearing aid, how much difficulty do you now have?" where lower scores are better.

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=130 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=120 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) In this situation, what proportion of the time do you wear your hearing aid?	87.61 average scores on a scale Standard Deviation 19.30	88.25 average scores on a scale Standard Deviation 21.09
Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) In this situation, how much does your hearing aid help you?	62.64 average scores on a scale Standard Deviation 23.32	59.08 average scores on a scale Standard Deviation 22.29
Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) In this situation, with your hearing aid, how much difficulty do you now have?	15.56 average scores on a scale Standard Deviation 12.38	19.91 average scores on a scale Standard Deviation 12.78
Hearing Aid Benefit, as Measured by the Measured by Glasgow Hearing Aid Benefit Profile (GHABP) For this situation, how satisfied are you with your hearing aid?	70.63 average scores on a scale Standard Deviation 21.38	66.46 average scores on a scale Standard Deviation 20.58

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: The BKB SIN test was missing for 17 individuals at 3 months (6 from bilateral group, 11 from unilateral group) 16 due to missed 3- month follow-up visit, 1 individual did not have the BKB SIN test during the 3-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

Speech and noise collocated and the speech reception threshold (SRT) for 50% performance will be calculated (in dB speech-to-noise ratio S/N).

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=133 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=125 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Change in Hearing Aid Benefit as Measured by Bamford-Kowal-Bench Speech in Noise (BKB SIN) Test	-1.51 dB Standard Deviation 3.57	-1.37 dB Standard Deviation 3.31

SECONDARY outcome

Timeframe: Baseline, 3 months

Population: Data was missing from 16 individuals at 3 months (6 from bilateral group, 10 from unilateral group) due to missed 3-month f/u visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The WARRM provides a word-recognition score and a recall score using 20 audio-recorded monosyllabic words distributed across set sizes of 2, 3, 4, 5, and 6 words. the WARRM is reported as percent correct, with higher scores indicating better performance.

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=133 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=126 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM) Word-recognition percent correct	15.56 percent correct responses Standard Deviation 19.59	14.48 percent correct responses Standard Deviation 19.12
Change in Hearing Aid Benefit as Measured by the Abbreviated Word Auditory Recognition and Recall Measure (WARRM) Recall score percent correct	3.01 percent correct responses Standard Deviation 13.48	4.72 percent correct responses Standard Deviation 14.32

SECONDARY outcome

Timeframe: 3 months , 6 months

Population: Data is missing for 18 individuals at 3 months (5 from bilateral group, 13 from unilateral group) 16 due to missed 3 month visit, 2 did not complete the SADL survey during the 3 month visit; and 60 individuals at 6 months (26 from bilateral group, 34 from unilateral group) 54 due to missed 6 month visit, 6 individuals did not complete the SADL at the 6 month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The SADL is a 15- item questionnaire, 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13).; A global score is used, which is the mean of scores for all items (excluding questions 11 and 14, if applicable). Higher scores indicate higher satisfaction .

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=134 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=123 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey 3 months	5.71 score on a scale Standard Deviation 0.75	5.7 score on a scale Standard Deviation 0.68
Hearing Aid Satisfaction as Measured by Satisfaction With Amplification in Daily Life (SADL) Survey 6 months	5.63 score on a scale Standard Deviation 0.81	5.64 score on a scale Standard Deviation 0.70

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months

Population: Data is missing for 19 individuals at 3 months (6 from bilateral group, 13 from unilateral group) 16 due to missed 3 month visit, 3 individuals did not complete the HHIE at the 3 month visit; and 68 individuals at 6 months (30 from bilateral group, 38 from unilateral group) 54 due to missed 3 month visit, 14 individuals did not complete the HHIE at the 6 month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The Hearing Handicap Inventory for Elderly (HHIE) survey is a 25 -item questionnaire on a response scale of "yes (4 points), sometimes (2 points) or no (0 points)". Higher score indicates more hearing handicap. Total range of scores at a given timepoint is 0 to 100.

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=133 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=123 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion Baseline to 3 months	-16.89 difference in scores on a scale Standard Deviation 15.71	-14.7 difference in scores on a scale Standard Deviation 14.33
Change in Hearing Related Quality Life as Measured by Hearing Handicap Inventory for Elderly (HHIE) Survey Completion Baseline to 6 months	-19.14 difference in scores on a scale Standard Deviation 17.95	-15.22 difference in scores on a scale Standard Deviation 14.77

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months

Population: Outcome measure is missing for 21 individuals at 3 months (7 from bilateral group, 14 from unilateral group) and 72 individuals at 6 months (32 from bilateral group, 40 from unilateral group). Due to missed 3 and 6-month visits, or missing/incomplete SSQ questionnaires from those visits. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The SSQ is a 49-item questionnaire using a response scale ranging from 0 to 10. Higher scores are better.

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=132 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=122 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey Baseline to 3 months	0.96 difference in overall scores on a scale Standard Deviation 1.27	0.58 difference in overall scores on a scale Standard Deviation 1.21
Change in Complex Ecological Listening as Measured by the Speech Spatial Qualities (SSQ) Survey Baseline to 6 months	0.83 difference in overall scores on a scale Standard Deviation 1.27	0.85 difference in overall scores on a scale Standard Deviation 1.21

SECONDARY outcome

Timeframe: 3 months

Population: Hours of hearing aid use in the right ear is missing for 73 individuals (7 from bilateral group, 66 from unilateral group), and left ear use is missing for 93 individuals (9 from bilateral group, 84 from unilateral group). 16 individuals did not complete the 3- month visit; Data was not collected during the 3- month visit for the other individuals. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

Average number of hours hearing aid worn, measured by automated data log extracted from hearing aid

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=132 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=70 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Hours of Hearing Aid Use Right ear	10.09 hours per day Standard Deviation 3.84	10.87 hours per day Standard Deviation 3.36
Hours of Hearing Aid Use Left ear	10.01 hours per day Standard Deviation 3.84	10.35 hours per day Standard Deviation 4.15

SECONDARY outcome

Timeframe: Baseline

Population: Outcome measure is missing for 18 individuals at 3 months (5 from bilateral group, 13 from unilateral group) due to missing data and/or missed 3-month visits; and 62 individuals at 6 months (27 from bilateral group, 35 from unilateral group), due to missing data and/or missed 6-month visits. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The ECHO survey is 15 questions, a 7-item response scale is used in 1-unit steps, 1 (poorest) to 7 (highest) for each item (reversed for items 2, 4, 7, 13). A global score is used, which is the mean of the scores for all items (excluding question 11, if applicable). Higher scores are better (higher expectations).

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=139 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=136 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Hearing Aid Expectations as Measured by the Expected Consequences of Hearing Aid Ownership (ECHO) Survey	5.01 scores on a scale Standard Deviation 0.64	5.05 scores on a scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: 3 months, 6 months

Population: Outcome measure is missing for 18 individuals at 3 months (5 from bilateral group, 13 from unilateral group) and 62 individuals at 6 months (27 from bilateral group, 35 from unilateral group). One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The IOI\_HA total score (ranging from 7 to 35) is calculated by summing the response across the 7 item questionnaire. Choices range from the poorest outcome (1 point) to the best outcome (5 points). Higher scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=134 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=123 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey 3 months	29.81 score on a scale Standard Deviation 3.64	29.06 score on a scale Standard Deviation 3.8
Global Hearing Aid Outcomes as Measured by the International Outcome Inventory for Hearing Aids (IOI_HA) Survey 6 months	29.88 score on a scale Standard Deviation 3.66	29.89 score on a scale Standard Deviation 3.56

SECONDARY outcome

Timeframe: 3 months

Population: Outcome measure is missing for 30 individuals at 3 months (12 from bilateral group, 18 from unilateral group), due to missing data and/or missed 3-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

Participants answered the question "How likely are you to recommend assignment to a friend or family member in need of hearing aids" on a 10-point scale (1=not at all likely, 10=very likely/full recommendation)

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=127 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=118 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire Answer 7-8	24 Participants	37 Participants
Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire Answer 1-6	11 Participants	28 Participants
Experience With Hearing Aid Assignment as Measured by a Self-reported Questionnaire Answer 9-10	92 Participants	53 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Missing choice at 3 months for 15 individuals (5 from bilateral group, 10 from unilateral group) due to missed 3-month visits. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

Measured by participant's final choice of 0, 1, or 2 hearing aids

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=134 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=126 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids Chose 0 hearing aids	1 Participants	1 Participants
Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids Chose 1 hearing aid	26 Participants	48 Participants
Number of Participants in Each Arm That Chose 0, 1, or 2 Hearing Aids Chose 2 hearing aids	107 Participants	77 Participants

SECONDARY outcome

Timeframe: Baseline, 6 months

Population: Missing data from 54 individuals (25 from bilateral group, 29 from unilateral group) due to missing data and/or missed 6-month visit. One participant from the Bilateral hearing aid fitting group was excluded from the analysis due to not being randomized properly.

The APHAB score ranges from 1 to 99. The change in APHAB score was calculated as the difference between scores at 6 months and baseline, so the range of possible values for the change score is -98 to 98. A lower APHAB score indicates a better benefit; a negative change score indicates greater benefit at 6 months than at baseline.

Outcome measures

Outcome measures
Measure	Bilateral Hearing Aid Fitting Group n=114 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss	Unilateral Hearing Aid Fitting Group n=107 Participants Hearing amplification: Bilateral vs. unilateral hearing aids for hearing loss
Change in Hearing Aid Benefit as Measured by Abbreviated Profile of Hearing Aid Benefit (APHAB)	-17.76 difference of scores on a scale Standard Deviation 14.32	-15.7 difference of scores on a scale Standard Deviation 12.97

Adverse Events

Bilateral Hearing Aid Fitting Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unilateral Hearing Aid Fitting Group

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

Sherri L. Smith, PhD, AuD, CCC-A

Duke University Medical Center

Phone: (919) 684-2426

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place