Hearing LossNCT03569228
Efficacy of a Coupler-based Fitting Approach for Experienced Users Receiving Replacement Hearing Aids
A study testing Study 1 - ITE hearing aids, Study 1 - BTE hearing aids and Study 3 (open-fit comparison) in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Study 1 - ITE hearing aids, Study 1 - BTE hearing aids and Study 3 (open-fit comparison)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study 1 and 3
- experienced hearing-aid users who are obtaining replacement VA-issued hearing aids of the same style and manufacturer as their current hearing aids
- no more than a moderate sensorineural hearing loss (defined as < 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
- symmetrical hearing between the ears as defined as no more than a 20 dB difference in pure-tone thresholds at two consecutive frequencies
- 50% word-recognition abilities in quiet as measured during the diagnostic audiologic evaluation
- An education-adjusted score of >21 on the Montreal Cognitive Assessment
- ability to read and write in English
- Study 2 Veterans aged 18-85 years with sensorineural hearing loss
Who cannot join
- Study 1 and 3
- outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
- a significant change in hearing on audiogram obtained during the current study and that obtained when fitted with the current (to-be replaced) hearing aids as defined by a 15 dB decline in thresholds at three consecutive frequencies in either ear
- lack of phone or non-use of the phone
- unwilling or unable to be mailed hearing aids
- co-morbid condition that would preclude their participation
Show all 9Show fewer
- Study 2
- co-morbid condition that would preclude their participation
- outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Many Veterans would like their replacement hearing aids mailed to them, but they are required to travel to the clinic so that the fit of the hearing aid can be verified. There are standard fitting procedures, such as those used in infants and children, that use a coupler to simulate the patient's real ear to verify the hearing aid fitting. The results of this study should determine the efficacy of a coupler-based hearing-aid fitting protocol that would not require the Veteran to attend the fitting appointment, thereby contributing to improved Veteran-Centric care.
Read the detailed description
In the VA system, hearing loss is the second-most common service-connected condition affecting 933,182 Veterans, exceeded only by tinnitus which affects 1,121,709 Veterans (data from Veterans Benefit Report for Fiscal Year 2016). In FY 2016, the VA dispensed 750,075 hearing aids at a net procurement of nearly $270 million (report generated from VA Denver Acquisition and Logistics Center [DALC] Remote Order Entry System [ROES]). Half of the hearing aids dispensed were to experienced hearing aid users receiving replacement hearing aids (Dennis, 2014). VA Audiology caseload is significant and Veterans can experience long wait-times for fitting appointments to obtain new hearing aids (Office of the Inspector General, 2014).
The purpose of the fitting appointment is to program and verify the hearing aids and orient the patient to hearing aid use/care. For patients obtaining replacement hearing aids, the orientation typically is unnecessary, and the programming is simplified; consisting mainly of matching the individual's real-ear aided response (REAR) and hearing aid output to appropriate target values. In contrast to adults, REAR measurements are not well-tolerated by children due to the requirement for placement of a probe tube in the ear canal. Therefore, a hearing aid fitting procedure that circumvents the need for in situ REAR measurements (real ear coupler difference or RECD) is the standard-of-care (SoC) for children. Considerable research clearly has shown the equivalency of in situ REAR and RECD fitting procedures (e.g., Moodie et al., 1994). RECD fitting procedures rarely are used with adults; however, such an approach could preclude the need for direct physical contact with the patient at the time of the hearing aid fitting. Three experiments are proposed. The purpose of the first study is to evaluate coupler-based fitting approach for groups of experienced users obtaining replacement hearing aids and compare the accuracy of those fittings to the prescription and their outcomes to norms. The second study aims to develop correction factors for venting of open-fit hearing aids. The third study will focus on comparing coupler-based fittings of open-fit hearing aids (using correction factors developed from study two results) to an SoC (active control) group who will have their open-fit hearing aids fitted in face-to-face appointment via standard in situ REAR procedures. In Study 1 and 3, both groups will return for in situ REARs and self-report outcomes assessment one month after the hearing-aid fitting. The results of this study should determine the efficacy of a RECD-based, hearing-aid fitting approach for experienced hearing-aid users who are receiving replacement hearing aids consisting of a variety of styles. If the approaches are equivalent, then this study will provide an evidence-based, RECD fitting approach that should result in greater patient satisfaction and reduced costs.
- Conditions
- Hearing Loss
- Being tested
- Study 1 - ITE hearing aids, Study 1 - BTE hearing aids, Study 3 (open-fit comparison), Study 3 (closed-fit comparison), Study 3 (experimental open-fit)
- Keywords
- hearing loss, hearing aids
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study 1 - ITE hearing aidsDevice
Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Study 1 - BTE hearing aidsDevice
Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Study 3 (open-fit comparison)Device
This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.
Study 3 (closed-fit comparison)Device
This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.
Study 3 (experimental open-fit)Device
Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
Study 3 (experimental closed-fit)Device
Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
| Study group | Role | What they receive |
|---|---|---|
| Study 1 (In-the-Ear) Group | Experimental | Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Receives: Device: Study 1 - ITE hearing aids |
| Study 1 (Behind-the-Ear) Group | Experimental | Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Receives: Device: Study 1 - BTE hearing aids |
| Study 2 (Open-Fit corrections) | No intervention | Participants with hearing loss will be fitted monaurally with 12 stock non-custom, receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids using the standard in-situ approach and test box measures will be made of each fitting to develop correction factors for these styles. |
| Study 3 (open-fit comparison) | Active comparator | This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. Receives: Device: Study 3 (open-fit comparison) |
| Study 3 (closed-fit comparison) | Active comparator | This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. Receives: Device: Study 3 (closed-fit comparison) |
| Study 3 (experimental open-fit) | Experimental | Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Receives: Device: Study 3 (experimental open-fit) |
| Study 3 (experimental closed-fit) | Experimental | Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. Receives: Device: Study 3 (experimental closed-fit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation From Target (in dB)
The primary outcome of interest is based on fitting accuracy across ears (i.e., the averaged absolute deviation from target of the average of 500, 1000, 2000, and 4000 Hz across both ears measured in decibels (dB)).
Measured: 1 month
Secondary outcomes (5)
Abbreviate Profile of Hearing Aid Benefit
Abbreviate Profile of Hearing Aid Benefit (APHAB; Cox and Alexander, 1995). The APHAB contains 24 items that assess hearing problems across four subscales including: (1) ease of communication, (2) background noise, (3) reverberation, and (4) aversiveness to sounds. Items are answered using a 7-item response scale ranging from never (1%) to almost always (99%). Items typically are answered in unaided and aided conditions. Higher numbers indicated more problems. The difference in scores between the two conditions is a measure of benefit. For this study, however, the aided-aided version of the APHAB will be used. Study 1 and 3.
Measured: 1 month
Client-Oriented Scale of Improvement
Client-Oriented Scale of Improvement (COSI; Dillon, James, \& Ginis, 1997). The listener nominates up to five listening goals on the COSI. After hearing-aid use, the listener assesses two outcomes for each goal. One outcome is the "degree of change" relative to the patient's unaided experience. Responses are recorded on a categorical scale from 'worse' to 'much better.' The second outcome is the final satisfactory "aided" ability for each goal as measured on a categorical scale from hardy ever (10%) to almost always (95%). The percentage of 'better' and 'much better' responses and the average of the final ability will be calculated across goals. Study 1 and 3.
Measured: 1 month
International Outcomes Inventory for Hearing Aids
International Outcomes Inventory for Hearing Aids (IOI-HA; Cox et al., 2000). The IOI-HA consists of seven items including (1) use, (2) benefit, (3) satisfaction, (4) residual activity limitation, (5) residual participation restriction, (6) impact on others, and (7) quality of life. Each item has a unique 1-5 response scale. Scores range from 7-35 with higher scores indicating higher outcomes. Study 1 and 3.
Measured: 1 month
Satisfaction With Amplification in Daily Life
Satisfaction with Amplification in Daily Life (SADL) (Cox and Alexander, 1999). The SADL questionnaire has 15 items that examine self-reported hearing-aid satisfaction. The following four subscales are included: (1) positive effect, (2) negative features, (3) personal image, and (4) service and cost. For the current study, item 14 on the service and cost subscale will not be used as the Veterans are not charged for the cost of their bilateral hearing aids. The SADL uses a 7-item response scale in 1-unit steps, 1 (poorest) to 7 (highest) for each item, which are averaged for each subscale and total scale score. Study 1 and 3.
Measured: 1 month
Client Oriented Scale of Improvement (COSI)
Degree of change (percentage of those goals that were categorized as 'better' or 'much better')
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start28 Oct 2019
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: Could not achieve recruitment goal due to COVID delays and staffing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study 1. Participants obtaining replacement in-the-ear (ITE) or behind-the ear (BTE) hearing aids will be assigned to the ITE or BTE coupler-based fitting groups. Study 2: Participants will be fitted with open-fit hearing aids using simulated audiograms. Study 3. Participants obtaining replacement open fit or receiver-in-the canal hearing aids will be randomly assigned to the standard of care fitting groups (open or closed) or the coupler-based fitting groups (open or closed).
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Candice M Quinn, PhD, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569228
- Sponsor's protocol ID
- C2777-R
- Status last verified
- May 2025
- First submitted
- 13 Jun 2018
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Coupler-based Fitting Approach for Experienced Users Receiving Replacement Hearing Aids
- ClinicalTrials.gov ID
- NCT03569228
- Acronym / sponsor ID
- C2777-R
- Conditions
- Hearing Loss
- Keywords
- hearing loss, hearing aids
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not achieve recruitment goal due to COVID delays and staffing.
- Enrolment
- 163 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hearing loss is among the top service-connected disabilities in Veterans. Hearing aids are the primary intervention for hearing loss. Half of the hearing aids dispensed in the VA are to Veterans who are receiving replacement amplification. Many Veterans would like their replacement hearing aids mailed to them, but they are required to travel to the clinic so that the fit of the hearing aid can be verified. There are standard fitting procedures, such as those used in infants and children, that use a coupler to simulate the patient's real ear to verify the hearing aid fitting. The results of this study should determine the efficacy of a coupler-based hearing-aid fitting protocol that would not require the Veteran to attend the fitting appointment, thereby contributing to improved Veteran-Centric care.
Detailed description
In the VA system, hearing loss is the second-most common service-connected condition affecting 933,182 Veterans, exceeded only by tinnitus which affects 1,121,709 Veterans (data from Veterans Benefit Report for Fiscal Year 2016). In FY 2016, the VA dispensed 750,075 hearing aids at a net procurement of nearly $270 million (report generated from VA Denver Acquisition and Logistics Center [DALC] Remote Order Entry System [ROES]). Half of the hearing aids dispensed were to experienced hearing aid users receiving replacement hearing aids (Dennis, 2014). VA Audiology caseload is significant and Veterans can experience long wait-times for fitting appointments to obtain new hearing aids (Office of the Inspector General, 2014).
The purpose of the fitting appointment is to program and verify the hearing aids and orient the patient to hearing aid use/care. For patients obtaining replacement hearing aids, the orientation typically is unnecessary, and the programming is simplified; consisting mainly of matching the individual's real-ear aided response (REAR) and hearing aid output to appropriate target values. In contrast to adults, REAR measurements are not well-tolerated by children due to the requirement for placement of a probe tube in the ear canal. Therefore, a hearing aid fitting procedure that circumvents the need for in situ REAR measurements (real ear coupler difference or RECD) is the standard-of-care (SoC) for children. Considerable research clearly has shown the equivalency of in situ REAR and RECD fitting procedures (e.g., Moodie et al., 1994). RECD fitting procedures rarely are used with adults; however, such an approach could preclude the need for direct physical contact with the patient at the time of the hearing aid fitting. Three experiments are proposed. The purpose of the first study is to evaluate coupler-based fitting approach for groups of experienced users obtaining replacement hearing aids and compare the accuracy of those fittings to the prescription and their outcomes to norms. The second study aims to develop correction factors for venting of open-fit hearing aids. The third study will focus on comparing coupler-based fittings of open-fit hearing aids (using correction factors developed from study two results) to an SoC (active control) group who will have their open-fit hearing aids fitted in face-to-face appointment via standard in situ REAR procedures. In Study 1 and 3, both groups will return for in situ REARs and self-report outcomes assessment one month after the hearing-aid fitting. The results of this study should determine the efficacy of a RECD-based, hearing-aid fitting approach for experienced hearing-aid users who are receiving replacement hearing aids consisting of a variety of styles. If the approaches are equivalent, then this study will provide an evidence-based, RECD fitting approach that should result in greater patient satisfaction and reduced costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- Study 1. Participants obtaining replacement in-the-ear (ITE) or behind-the ear (BTE) hearing aids will be assigned to the ITE or BTE coupler-based fitting groups. Study 2: Participants will be fitted with open-fit hearing aids using simulated audiograms. Study 3. Participants obtaining replacement open fit or receiver-in-the canal hearing aids will be randomly assigned to the standard of care fitting groups (open or closed) or the coupler-based fitting groups (open or closed).
| Arm | Type | Receives |
|---|---|---|
| Study 1 (In-the-Ear) Group | Experimental | Device: Study 1 - ITE hearing aidsExperienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. |
| Study 1 (Behind-the-Ear) Group | Experimental | Device: Study 1 - BTE hearing aidsExperienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. |
| Study 2 (Open-Fit corrections) | No intervention | –Participants with hearing loss will be fitted monaurally with 12 stock non-custom, receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids using the standard in-situ approach and test box measures will be made of each fitting to develop correction factors for these styles. |
| Study 3 (open-fit comparison) | Active comparator | Device: Study 3 (open-fit comparison)This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. |
| Study 3 (closed-fit comparison) | Active comparator | Device: Study 3 (closed-fit comparison)This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. |
| Study 3 (experimental open-fit) | Experimental | Device: Study 3 (experimental open-fit)Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. |
| Study 3 (experimental closed-fit) | Experimental | Device: Study 3 (experimental closed-fit)Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Study 1 and 3
- experienced hearing-aid users who are obtaining replacement VA-issued hearing aids of the same style and manufacturer as their current hearing aids
- no more than a moderate sensorineural hearing loss (defined as < 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
- symmetrical hearing between the ears as defined as no more than a 20 dB difference in pure-tone thresholds at two consecutive frequencies
- 50% word-recognition abilities in quiet as measured during the diagnostic audiologic evaluation
Key exclusion criteria (9 listed)
- Study 1 and 3
- outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
- a significant change in hearing on audiogram obtained during the current study and that obtained when fitted with the current (to-be replaced) hearing aids as defined by a 15 dB decline in thresholds at three consecutive frequencies in either ear
- lack of phone or non-use of the phone
- unwilling or unable to be mailed hearing aids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study 1 - ITE hearing aidsExperienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | Device | Study 1 (In-the-Ear) Group |
| Study 1 - BTE hearing aidsExperienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | Device | Study 1 (Behind-the-Ear) Group |
| Study 3 (open-fit comparison)This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial. | Device | Study 3 (open-fit comparison) |
| Study 3 (closed-fit comparison)This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial. | Device | Study 3 (closed-fit comparison) |
| Study 3 (experimental open-fit)Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | Device | Study 3 (experimental open-fit) |
| Study 3 (experimental closed-fit)Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial. | Device | Study 3 (experimental closed-fit) |
Primary outcome
Deviation From Target (in dB)
Time frame: 1 month
The primary outcome of interest is based on fitting accuracy across ears (i.e., the averaged absolute deviation from target of the average of 500, 1000, 2000, and 4000 Hz across both ears measured in decibels (dB)).
5 secondary outcomes
Abbreviate Profile of Hearing Aid Benefit
Time frame: 1 month
Client-Oriented Scale of Improvement
Time frame: 1 month
International Outcomes Inventory for Hearing Aids
Time frame: 1 month
Satisfaction With Amplification in Daily Life
Time frame: 1 month
Client Oriented Scale of Improvement (COSI)
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candice M Quinn, PhD principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study 1 - ITE hearing aids, Study 1 - BTE hearing aids and Study 3 (open-fit comparison) in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deviation From Target (in dB) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.