An interventional study of mild-gain hearing aids with high-frequency emphasis over 6-months in Hearing Impairment and Hearing Aid Fitting, sponsored by VA Office of Research and Development. Completed at 3 sites in United States. Open to participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
The purpose of this study is to study blast-exposed Veterans who report hearing handicap but show normal or near normal results on standard audiometric testing. The characteristics and nature of their auditory and auditory-related skills will be examined, along with whether coexisting PTSD contributes to the hearing problems of these Veterans. In a preliminary treatment study, a sub-sample of these Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.
The purpose of this study is to study blast-exposed Veterans who report hearing handicap but show normal or near normal results on standard audiometric testing. The characteristics and nature of their auditory and auditory-related skills will be examined with a battery of behavioral and physiologic measures. The potential contributions of co-occurring PTSD also will be evaluated. In a preliminary treatment study, a sub-sample of the targeted Veterans will be fitted with mild-gain hearing aids to determine if they benefit from low-level amplification of high-frequency sounds.
This study consists of two parts. In Part 1, four groups of Veterans, aged 20 - 50 years, will complete a battery of auditory and auditory-related assessments to better understand the deficit sources and patterns. The assessment measures will consist of questionnaires, behavioral tests, and auditory physiologic measures. One group will consist of blast-exposed Veterans with auditory problems but no PTSD. The second group will consist of blast-exposed Veterans with auditory problems plus PTSD. The third group will consist of Veterans with PTSD but no reported auditory problems, and the fourth groups will be a normal control group.
In Part 2 of the study (clinical trial portion), a smaller group of participants from the first and second groups will be fitted with mild-gain open-fit hearing aids to determine if they benefit from mild high-frequency amplification. Changes in hearing handicap and speech perception will be compared from baseline to 6-months post-fitting. Perceived hearing aid benefit, hearing aid use time, and intent to continue use will be measured at the end of a 6-month treatment period. A delayed treatment group will be formed from group 1 and will be followed over a 12-month period with hearing aids fitted at 6 months. The participants will be assigned randomly from Part 1 of the study.
The information obtained from this study will help us understand the auditory problems experienced by blast-exposed Veterans and eventually contribute to the development of an efficient and effective assessment battery and intervention approaches.
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Exclusion Criteria:
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.
Device: mild-gain hearing aids with high-frequency emphasis over 6-months
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.
Device: mild-gain hearing aids with high-frequency emphasis over 6-months
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.
Device: mild-gain hearing aids with high-frequency emphasis over 6-months
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.
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.
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.
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.
open-fit hearing aids with mild amplification in the high frequencies.
Also known as: hearing aids
Hearing Handicap Inventory for Adults (HHIA)
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.
Time frame: 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.
Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB)
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.
Time frame: 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).
Intent to Continue Use
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.
Time frame: 6 months post-fitting
Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day)
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.
Time frame: Hearing aid use time was collected at 6 months post-fitting.
Speech Perception in Quiet and in Noise
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).
Time frame: The CCT was administered immediately pre-fitting (unaided), 1 week post-fitting (aided), and 6 months post-fitting (aided).
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).
| Milestone | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-treatment Diagnostic Testing: PTSD Only |
|---|---|---|---|---|---|---|---|
| Started | 12 | 18 | 7 | 82 | 45 | 43 | 19 |
| Completed | 9 | 13 | 7 | 67 | 31 | 23 | 18 |
| Not completed | 3 | 5 | 0 | 15 | 14 | 20 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 4 | 4 | 4 | 0 |
| Withdrew: Lost to follow-up | 1 | 3 | 0 | 7 | 5 | 15 | 1 |
| Withdrew: Did not qualify at initial testing or after chart review | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Experimental error | 0 | 0 | 0 | 0 | 3 | 0 | 0 |
| Withdrew: Deployed or moved | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Scheduling delays - unable to complete | 0 | 1 | 0 | 4 | 1 | 1 | 0 |
| Withdrew: Noncompliance | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
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.
| Scale score | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only |
|---|---|---|---|
| Hearing Handicap Inventory for Adults (HHIA) | 26.20 (19.04 to 33.33) | 37.34 (31.37 to 43.32) | 19.21 (10.48 to 27.95) |
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.
| Scale score | Immediate Hearing Aid Treatment: Blast-Exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only |
|---|---|---|---|
| Hearing Aid Benefit (Abbreviated Profile of Hearing Aid Benefit, APHAB) | -.362 ± .301 | -.270 ± .821 | -.080 ± .331 |
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.
| Participants | Immediate Hearing Aid Treatment: Blast-Exposed Only | Immediate Hearing Aid Treatment: Blast-Exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only |
|---|---|---|---|
| Intent to Continue Use | 9 | 13 | 7 |
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.
| Participants | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only |
|---|---|---|---|
| Hearing Aid Use Time (Number of Participants With an Average Hearing Aid Use Time of 4 Hours a Day) | 9 | 7 | 3 |
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).
| Proportion Correct | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only |
|---|---|---|---|
| Pre-fitting Score in Quiet | .92 ± .017 | .93 ± .013 | .95 ± .018 |
| Pre-fitting Score in Noise | .69 ± .044 | .73 ± .033 | .72 ± .047 |
| 1-week Post-fitting Test Score in Quiet | .96 ± .018 | .93 ± .014 | .95 ± .019 |
| 1-week Post-fitting Test Score in Noise | .83 ± .046 | .79 ± .035 | .79 ± .049 |
| Final Test Score in Quiet | .96 ± .009 | .95 ± .007 | .95 ± .010 |
| Final Test Score in Noise | .84 ± .037 | .82 ± .028 | .71 ± .040 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Hearing Aid Treatment: Blast-exposed Only | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) |
| Immediate Hearing Aid Treatment: Blast-exposed With PTSD | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Delayed Hearing Aid Treatment: Blast-exposed Only | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Non-treatment Diagnostic Testing: Normal | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| Non-treatment Diagnostic Testing: Blast-exposed Only | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Non-treatment Diagnostic Testing: Blast-exposed With PTSD | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| Non-treatment Diagnostic Testing: PTSD Only | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Event | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-treatment Diagnostic Testing: PTSD Only |
|---|---|---|---|---|---|---|---|
| Middle ear infection and massEar and labyrinth disorders | 1/12 | 0/18 | 0/7 | 0/82 | 0/45 | 0/43 | 0/19 |
Veterans between the ages of 20 and 50 years of age who had normal hearing on standard audiometric testing, who had significant or no self-reported hearing handicap, significant or no history of blast-exposure, significant or no PTSD, normal vision and no history of prior brain injuries or diseases that were not blast-related. Preliminary testing and review of clinical records excluded 137 participants. These participants are not included in the baseline participant numbers.
| Age, Continuous(Years) | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-Treatment Diagnostic Testing: PTSD Only | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 37.01 ± 8.63 | 37.46 ± 6.73 | 39.21 ± 8.47 | 35.23 ± 8.29 | 35.32 ± 6.72 | 34.52 ± 6.42 | 34.85 ± 8.10 | 37.08 ± 7.77 |
| Sex/Gender, Customized(Participants) | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-Treatment Diagnostic Testing: PTSD Only | Total |
|---|---|---|---|---|---|---|---|---|
| Participants by Sex — Number of Male Participants Per Arm | 10 | 15 | 7 | 56 | 39 | 38 | 10 | 175 |
| Participants by Sex — Number of Female Participants Per Arm | 2 | 3 | 0 | 26 | 6 | 5 | 9 | 51 |
| Ethnicity (NIH/OMB)(Participants) | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-Treatment Diagnostic Testing: PTSD Only | Total |
|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 0 | 8 | 5 | 4 | 1 | 21 |
| Not Hispanic or Latino | 10 | 17 | 7 | 73 | 40 | 39 | 18 | 204 |
| Unknown or Not Reported | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-Treatment Diagnostic Testing: PTSD Only | Total |
|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 4 |
| Asian | 0 | 0 | 0 | 1 | 0 | 2 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 2 | 0 | 2 | 14 | 2 | 5 | 1 | 26 |
| White | 10 | 15 | 3 | 56 | 40 | 32 | 16 | 172 |
| More than one race | 0 | 1 | 0 | 9 | 3 | 4 | 1 | 18 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-Treatment Diagnostic Testing: PTSD Only | Total |
|---|---|---|---|---|---|---|---|---|
| United States | 12 | 18 | 7 | 82 | 45 | 43 | 19 | 226 |
| Age(Years) | Immediate Hearing Aid Treatment: Blast-exposed Only | Immediate Hearing Aid Treatment: Blast-exposed With PTSD | Delayed Hearing Aid Treatment: Blast-exposed Only | Non-treatment Diagnostic Testing: Normal | Non-treatment Diagnostic Testing: Blast-exposed Only | Non-treatment Diagnostic Testing: Blast-exposed With PTSD | Non-Treatment Diagnostic Testing: PTSD Only | Total |
|---|---|---|---|---|---|---|---|---|
| Mean | 37.01 (26.4 to 50.6) | 37.46 (27.7 to 49.1) | 39.21 (28.3 to 50.9) | 35.23 (20.6 to 50.9) | 35.32 (23.2 to 49.9) | 34.52 (23.4 to 48.6) | 34.85 (25.10 to 49.10) | 37.08 (20.6 to 50.9) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — De-identified Individual participant data and the study data dictionary will be made available upon request to the PI (spratt@pitt.edu).
Supporting information: Study protocol, Sap
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