Trial Outcomes & Findings for Blast Exposed Veterans With Auditory Complaints (NCT NCT02122458)

Last Updated: 2023-06-22

Results Overview

Self-perceived hearing handicap was measured with the Hearing Handicap Inventory for Adults (HHIA), pre- and 6-months post-hearing aid fitting. The minimum score is 0 and the maximum score is 100, with the higher score reflecting greater handicap (worse outcome). The data are presented as a comparison between the two questionnaire administrations (pre- and 6-months post-fitting). The null hypothesis tested was that there would be no difference between the HHIA administered at baseline (pre-fitting) and 6-months post-fitting for all groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

363 participants

Primary outcome timeframe

The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.

Results posted on

2023-06-22

Participant Flow

The participants were recruited through flyers, letters, VA audiologists, and Veteran organizations. Recruitment activities occurred Year 1 through Year 4 of the study. It should be noted that the participants enrolled in the hearing aid treatment arms (clinical trial portion of the study) completed diagnostic testing prior to completing the hearing aid treatment. The remaining participants only completed the diagnostic testing (Non-treatment Diagnostic Testing).

Preliminary testing and review of clinical records excluded 137 participants prior to group assignment.

Participant milestones

Participant milestones
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.	Non-treatment Diagnostic Testing: Normal This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.	Non-treatment Diagnostic Testing: Blast-exposed Only This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.	Non-treatment Diagnostic Testing: Blast-exposed With PTSD This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.	Non-treatment Diagnostic Testing: PTSD Only This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.
Overall Study STARTED	12	18	7	82	45	43	19
Overall Study COMPLETED	9	13	7	67	31	23	18
Overall Study NOT COMPLETED	3	5	0	15	14	20	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Non-treatment Diagnostic Testing: Normal This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.	Non-treatment Diagnostic Testing: Blast-exposed Only This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.	Non-treatment Diagnostic Testing: Blast-exposed With PTSD This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.	Non-treatment Diagnostic Testing: PTSD Only This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.
Overall Study Withdrawal by Subject	0	0	4	4	4	0
Overall Study Lost to Follow-up	1	3	7	5	15	1
Overall Study Did not qualify at initial testing or after chart review	1	0	0	0	0	0
Overall Study Adverse Event	1	0	0	0	0	0
Overall Study Experimental Error	0	0	0	3	0	0
Overall Study Deployed or Moved	0	0	0	1	0	0
Overall Study Scheduling Delays - Unable to Complete	0	1	4	1	1	0
Overall Study Noncompliance	0	1	0	0	0	0

Baseline Characteristics

Blast Exposed Veterans With Auditory Complaints

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n=12 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n=18 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only n=7 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.	Non-treatment Diagnostic Testing: Normal n=82 Participants This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.	Non-treatment Diagnostic Testing: Blast-exposed Only n=45 Participants This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.	Non-treatment Diagnostic Testing: Blast-exposed With PTSD n=43 Participants This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.	Non-Treatment Diagnostic Testing: PTSD Only n=19 Participants This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.	Total n=226 Participants Total of all reporting groups
Age, Continuous	37.01 Years STANDARD_DEVIATION 8.63 • n=5 Participants	37.46 Years STANDARD_DEVIATION 6.73 • n=7 Participants	39.21 Years STANDARD_DEVIATION 8.47 • n=5 Participants	35.23 Years STANDARD_DEVIATION 8.29 • n=4 Participants	35.32 Years STANDARD_DEVIATION 6.72 • n=21 Participants	34.52 Years STANDARD_DEVIATION 6.42 • n=8 Participants	34.85 Years STANDARD_DEVIATION 8.10 • n=8 Participants	37.08 Years STANDARD_DEVIATION 7.77 • n=24 Participants
Sex/Gender, Customized Participants by Sex · Number of Male Participants Per Arm	10 Participants n=5 Participants	15 Participants n=7 Participants	7 Participants n=5 Participants	56 Participants n=4 Participants	39 Participants n=21 Participants	38 Participants n=8 Participants	10 Participants n=8 Participants	175 Participants n=24 Participants
Sex/Gender, Customized Participants by Sex · Number of Female Participants Per Arm	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	26 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	9 Participants n=8 Participants	51 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	8 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	21 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	17 Participants n=7 Participants	7 Participants n=5 Participants	73 Participants n=4 Participants	40 Participants n=21 Participants	39 Participants n=8 Participants	18 Participants n=8 Participants	204 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	4 Participants n=24 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	4 Participants n=24 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	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	14 Participants n=4 Participants	2 Participants n=21 Participants	5 Participants n=8 Participants	1 Participants n=8 Participants	26 Participants n=24 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	15 Participants n=7 Participants	3 Participants n=5 Participants	56 Participants n=4 Participants	40 Participants n=21 Participants	32 Participants n=8 Participants	16 Participants n=8 Participants	172 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	9 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=8 Participants	1 Participants n=8 Participants	18 Participants n=24 Participants
Race (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	0 Participants n=8 Participants	1 Participants n=24 Participants
Region of Enrollment United States	12 Participants n=5 Participants	18 Participants n=7 Participants	7 Participants n=5 Participants	82 Participants n=4 Participants	45 Participants n=21 Participants	43 Participants n=8 Participants	19 Participants n=8 Participants	226 Participants n=24 Participants
Age	37.01 Years n=5 Participants	37.46 Years n=7 Participants	39.21 Years n=5 Participants	35.23 Years n=4 Participants	35.32 Years n=21 Participants	34.52 Years n=8 Participants	34.85 Years n=8 Participants	37.08 Years n=24 Participants

PRIMARY outcome

Timeframe: The participants wore their hearing aids for 6 months-fitting (baseline to 6-months post-fitting). The delayed group had a 6-month delay prior to treatment.

Population: A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 37 participants did not complete the treatment. The handicap scale was administered twice (pre-fitting and 6-months post-fitting) to the three groups. The Outcome Measure Data Table reflect comparisons between the overall scores for the 2 questionnaire administrations.

Outcome measures

Outcome measures
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n=9 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n=13 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only n=7 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.
Hearing Handicap Inventory for Adults (HHIA)	26.20 Scale score Interval 19.04 to 33.33	37.34 Scale score Interval 31.37 to 43.32	19.21 Scale score Interval 10.48 to 27.95

PRIMARY outcome

Timeframe: The APHAB was administered 6-months post-fitting. The delayed group had a 6-month delay prior to the treatment (6-months of wearing the hearing aids).

Population: A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 36 participants did not complete the treatment. The APHAB benefit data shown here were collected at 6-months post-fitting (end of the treatment) from the 3 groups of participants. One APHAB (aided and unaided portions) was completed per participant.

The Abbreviated Profile of Hearing Aid Benefit (APHAB) was administered at the end of the treatment period (6-months post-fitting) to measure self-perceived benefit. The APHAB is a 24-item self-assessment inventory used to indicate the extent to which listeners experience listening difficulties (with and without hearing aids) in various settings. The questionnaire uses a 7-point scale that corresponds to the frequency with which difficulties are experienced (99 to 1% of the time). The APHAB was administered for both unaided listening and aided listening, and benefit was calculated by subtracting the mean aided scores from the mean unaided scores. Higher benefit scores (e.g., 99% unaided - 25% aided vs. 99% unaided - 50% aided) reflected greater benefit (better outcome) and negative scores were possible. The null hypothesis tested was that no hearing aid benefit would be demonstrated by any of the 3 groups at 6-months post-fitting.

Outcome measures

Outcome measures
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n=9 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n=13 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only n=7 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.
Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)	-.362 Scale score Standard Deviation .301	-.270 Scale score Standard Deviation .821	-.080 Scale score Standard Deviation .331

PRIMARY outcome

Timeframe: 6 months post-fitting

Population: A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 36 participants did not complete the treatment. The data shown here were collected at 6-months post-fitting (end of the treatment) from the 3 groups of participants.

The participants reported whether they would continue to use their hearing aids after the study has ended. The null hypothesis tested was that neither group would demonstrate a significant preference for retaining their hearing aids.

Outcome measures

Outcome measures
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n=9 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n=13 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only n=7 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.
Intent to Continue Use	9 Participants	13 Participants	7 Participants

SECONDARY outcome

Timeframe: Hearing aid use time was collected at 6 months post-fitting.

Population: These data are a count of participants who wore their hearing aids at least 4 hours per day on average after 1 month of use. A total of 37 participants were recruited to enroll in the treatment (clinical trial) part of the study. Eight of these 37 participants did not complete the treatment.

Hearing aid use time was the number of participants who wore their hearing aids for an average of at least 4 hours per day. The average number of hours that the participants used their hearing aids was measured by their hearing aid data logging systems. These data were collected at the end of the treatment interval for each participant and were considered a positive outcome if they wore their hearing aids at least 4 hours a day on average after 1 month of use. The null hypothesis tested was that none of the participants in the three groups would not demonstrate hearing aid use time 4 hours or more, on average per day.

Outcome measures

Outcome measures
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n=9 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n=13 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only n=7 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.
Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)	9 Participants	7 Participants	3 Participants

SECONDARY outcome

Timeframe: The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).

The participants' speech perception was measured at the word level with the California Consonant Test (CCT). The CCT is a 50 item a closed-set word identification test. It was administered at 3 timepoints (pre-fitting, 1-week post-fitting, and 6-months post-fitting), with testing was completed in quiet and in background noise (speech babble, +3 dB signal/babble) at each timepoint. The participants were unaided during the pre-fitting testing but wore their hearing aids during the two post-fitting sessions. The outcome measure was the proportion of correct trials out of 50. A correct trial consisted of an accurate identification of the target word presented to the participant in the sound-field at 40 dB sensation level. The null hypothesis tested was that speech perception would not improve over the treatment intervals for the groups for either test condition (quiet and noise).

Outcome measures

Outcome measures
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n=9 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n=13 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only n=7 Participants This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.
Speech Perception in Quiet and in Noise Pre-fitting Score in Quiet	.92 Proportion Correct Standard Deviation .017	.93 Proportion Correct Standard Deviation .013	.95 Proportion Correct Standard Deviation .018
Speech Perception in Quiet and in Noise Pre-fitting Score in Noise	.69 Proportion Correct Standard Deviation .044	.73 Proportion Correct Standard Deviation .033	.72 Proportion Correct Standard Deviation .047
Speech Perception in Quiet and in Noise 1-week Post-fitting Test Score in Quiet	.96 Proportion Correct Standard Deviation .018	.93 Proportion Correct Standard Deviation .014	.95 Proportion Correct Standard Deviation .019
Speech Perception in Quiet and in Noise 1-week Post-fitting Test Score in Noise	.83 Proportion Correct Standard Deviation .046	.79 Proportion Correct Standard Deviation .035	.79 Proportion Correct Standard Deviation .049
Speech Perception in Quiet and in Noise Final Test Score in Quiet	.96 Proportion Correct Standard Deviation .009	.95 Proportion Correct Standard Deviation .007	.95 Proportion Correct Standard Deviation .010
Speech Perception in Quiet and in Noise Final Test Score in Noise	.84 Proportion Correct Standard Deviation .037	.82 Proportion Correct Standard Deviation .028	.71 Proportion Correct Standard Deviation .040

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Immediate Hearing Aid Treatment: Blast-exposed Only n=12 participants at risk This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Immediate Hearing Aid Treatment: Blast-exposed With PTSD n=18 participants at risk This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD. They were fitted with open-fit hearing aids that provided mild high-frequency amplification and were monitored for 6 months.	Delayed Hearing Aid Treatment: Blast-exposed Only n=7 participants at risk This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were negative for significant PTSD. They were fitted with hearing aids after a 6-month delay. Their performance was monitored 6-months pre-fitting and for the 6 months after the fitting.	Non-treatment Diagnostic Testing: Normal n=82 participants at risk This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group included neurotypical Veterans with normal hearing and were negative for blast-exposure and PTSD.	Non-treatment Diagnostic Testing: Blast-exposed Only n=45 participants at risk This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. They were negative for significant PTSD.	Non-treatment Diagnostic Testing: Blast-exposed With PTSD n=43 participants at risk This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group consisted of blast-exposed Veterans with auditory complaints but normal audiometric test results. These Veterans were comorbid for significant PTSD.	Non-treatment Diagnostic Testing: PTSD Only n=19 participants at risk This group consisted of Veterans who completed the same pre-treatment diagnostic testing as the three treatment groups but were not enrolled in the hearing aid treatment protocol. This group was negative for blast-exposure and hearing loss but positive for significant PTSD.
Ear and labyrinth disorders Middle ear infection and mass	8.3% 1/12 • Number of events 1 • Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year. This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.	0.00% 0/18 • Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year. This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.	0.00% 0/7 • Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year. This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.	0.00% 0/82 • Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year. This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.	0.00% 0/45 • Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year. This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.	0.00% 0/43 • Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year. This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.	0.00% 0/19 • Adverse events were queried for each individual participant per session from enrollment to completion of their participation in study and summarized yearly at IRB renewal, Adverse Events were collected for 6 months from all participants except for those enrolled in the Delayed Hearing Aid Treatment Arm/Group, which was assessed for up to 1 year. This was a minimal risk study, so adverse events were not expected but recorded and reported if they occurred or were reported by participants.

Other adverse events

Adverse event data not reported

Additional Information

Sheila R. Pratt, Ph.D.

VA Pittsburgh Healthcare System

Phone: 412-979-3157

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place