Hearing LossNCT00727909
Evaluation of Open-canal Behind-the-Ear Hearing Aids and Traditional In-the-ear Hearing Aids.
A study testing Hearing Aid Treatments in people with Hearing Loss, run by US Department of Veterans Affairs at 3 sites in United States.
Trial summary
This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so we can make better choices about which type of hearing aid is best for which patients. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing Aid Treatments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2009to Sep 2011
- 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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sensorineural hearing loss
- Veteran-adult onset of hearing
- English as first language
- Eligible for VA issued hearing aids
- Eligible to receive care at one of the three participating VA sites: Nashville, Tennessee, Mountain Home Tennessee, Bay Pines Florida
Who cannot join
- Known neurological, psychiatric disorders, or co-morbid disease that would prevent completion of the study
- Inadequate vision
- Inadequate reading skills
Trial locations and contacts
3 sites in 1 country.
United States3 sites
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708
James H. Quillen VA Medical Center
Mountain Home, Tennessee, 37684
VA Medical Center
Nashville, Tennessee, 37212-2637
About this study
Official title: Evaluation of Open-Ear Canal and Traditional Custom-Fit Hearing Aids
This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so we can make better choices about which type of hearing aid is best for which patients. Participants in this study will try three different sets of hearing aids for 2 months each, then we will evaluate the benefit of each type. Participants must be Veterans who are eligible for audiology care at one of the three participating sites.
Read the detailed description
Hearing loss is the most common service-connected disability nationwide in the Veteran's Health Administration (VHA) system, with hearing aids providing the primary treatment option. Although the benefits of hearing-aid use are clearly established,~16-30% of adults who have hearing aids do not use them. Several factors are believed to result in non-use of traditional hearing aids, including (1) poor fit and comfort, (2) poor cosmetics, (3) whistling feedback, (4) occlusion, and (5) difficulty understanding speech in noise.
Recently, the open canal (OC) hearing-aid style has become a viable approach to addressing address many of the problems resulting in non-use of traditional hearing aids, particularly for individuals with mild to moderately-severe hearing loss. Although an OC hearing aid has many potential advantages, there also are potential limitations. For example, the maximum low and high-frequency gain available with an OC fitting is less than that available from traditional custom (TC) hearing-aid fittings, which could result in less than optimal amplification for some individuals. In addition, directional microphone benefits for speech understanding in noise, available with TC fittings, likely will be limited with OC fittings due to the loss of low-frequency gain (Ricketts et al., 2005).
Since both OC and TC fittings are appropriate for listeners with mild to moderately-severe hearing losses, evidence is needed to determine which style of hearing aid is preferred by a majority. Currently, OC fittings use a small behind-the-ear (BTE) hearing aid coupled to a thin tube or plastic covered wire ending in a vented "open" ear tip. When a TC fitting is used with patients with similar hearing losses, the majority are either an in-the-ear (ITE) or in-the-canal (ITC) .In the proposed study a comparison will be made between OC vs. TC fittings. In addition to this primary comparison, preference for one of two OC hearing aids, viz., OC instruments with receiver in the ear (OCRITE) and the OC instruments with receiver in the hearing-aid case (OCRIHA), will be determined. The outcomes of the OCRITE, OCRIHA, and TC hearing-aid use related to the factors of: (1) comfort and cosmetics, (2) subjective occlusion, (3) objective occlusion, (4) sound quality for external sounds, (5) feedback, (6) ease of use, (7) audibility, (8) aided signal-to-noise ratio (SNR) benefit, and (9) localization, will be measured in a large (n = 288), randomized-controlled, three-site (Bay Pines, Mountain Home, and Nashville) clinical trial, utilizing a three-period (two months each), cross-over design. A total of 13 variables will be measured for the 9 hearing-aid fitting and style-related factors. At the end of the study, participants will rank order their preferences for the three hearing aid fittings to determine (1) the preferred OC fitting (OCRITE vs. OCRIHA) and (2) whether the highest ranked OC fitting or the TC fitting is preferred. Preferred OC vs. TC difference scores will be calculated for all relevant variables. The ability of the differences scores to predict the preferences of the participants for an OC vs. TC hearing aid will be determined, in order to develop an evidence-based hearing aid selection model.
- Conditions
- Hearing Loss
- Being tested
- Hearing Aid Treatments
- Keywords
- Hearing loss, Hearing Aids, Speech Perception, Persons with Hearing Impairment
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Aid TreatmentsDevice
Hearing aid treatments:
Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE)
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid Treatments | Experimental | Hearing aid treatments:
TC (Traditional Custom), RITA (Receiver-in-the Aid), and RITE (Receiver-in the-Ear) Receives: Device: Hearing Aid Treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Selected a Particular Type of Hearing Aid
Measured: At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2008 (estimated)
- Study startMay 2009
- Primary completionSep 2011
- Study completionSep 2011
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Gene W. Bratt, PhD MA BA, Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00727909
- Sponsor's protocol ID
- C6288-R
- Status last verified
- Jun 2014
- First submitted
- 30 Jul 2008
- Last updated
- 10 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Open-Ear Canal and Traditional Custom-Fit Hearing Aids
- ClinicalTrials.gov ID
- NCT00727909
- Acronym / sponsor ID
- C6288-R
- Conditions
- Hearing Loss
- Keywords
- Hearing loss, Hearing Aids, Speech Perception, Persons with Hearing Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Vanderbilt University
- Study start
- May 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 4 Aug 2008 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to evaluate the benefits of in-the-ear vs. open-fit behind-the-ear hearing aids. We want to learn more about which patients prefer each type, so we can make better choices about which type of hearing aid is best for which patients. Participants in this study will try three different sets of hearing aids for 2 months each, then we will evaluate the benefit of each type. Participants must be Veterans who are eligible for audiology care at one of the three participating sites.
Detailed description
Hearing loss is the most common service-connected disability nationwide in the Veteran's Health Administration (VHA) system, with hearing aids providing the primary treatment option. Although the benefits of hearing-aid use are clearly established,~16-30% of adults who have hearing aids do not use them. Several factors are believed to result in non-use of traditional hearing aids, including (1) poor fit and comfort, (2) poor cosmetics, (3) whistling feedback, (4) occlusion, and (5) difficulty understanding speech in noise.
Recently, the open canal (OC) hearing-aid style has become a viable approach to addressing address many of the problems resulting in non-use of traditional hearing aids, particularly for individuals with mild to moderately-severe hearing loss. Although an OC hearing aid has many potential advantages, there also are potential limitations. For example, the maximum low and high-frequency gain available with an OC fitting is less than that available from traditional custom (TC) hearing-aid fittings, which could result in less than optimal amplification for some individuals. In addition, directional microphone benefits for speech understanding in noise, available with TC fittings, likely will be limited with OC fittings due to the loss of low-frequency gain (Ricketts et al., 2005).
Since both OC and TC fittings are appropriate for listeners with mild to moderately-severe hearing losses, evidence is needed to determine which style of hearing aid is preferred by a majority. Currently, OC fittings use a small behind-the-ear (BTE) hearing aid coupled to a thin tube or plastic covered wire ending in a vented "open" ear tip. When a TC fitting is used with patients with similar hearing losses, the majority are either an in-the-ear (ITE) or in-the-canal (ITC) .In the proposed study a comparison will be made between OC vs. TC fittings. In addition to this primary comparison, preference for one of two OC hearing aids, viz., OC instruments with receiver in the ear (OCRITE) and the OC instruments with receiver in the hearing-aid case (OCRIHA), will be determined. The outcomes of the OCRITE, OCRIHA, and TC hearing-aid use related to the factors of: (1) comfort and cosmetics, (2) subjective occlusion, (3) objective occlusion, (4) sound quality for external sounds, (5) feedback, (6) ease of use, (7) audibility, (8) aided signal-to-noise ratio (SNR) benefit, and (9) localization, will be measured in a large (n = 288), randomized-controlled, three-site (Bay Pines, Mountain Home, and Nashville) clinical trial, utilizing a three-period (two months each), cross-over design. A total of 13 variables will be measured for the 9 hearing-aid fitting and style-related factors. At the end of the study, participants will rank order their preferences for the three hearing aid fittings to determine (1) the preferred OC fitting (OCRITE vs. OCRIHA) and (2) whether the highest ranked OC fitting or the TC fitting is preferred. Preferred OC vs. TC difference scores will be calculated for all relevant variables. The ability of the differences scores to predict the preferences of the participants for an OC vs. TC hearing aid will be determined, in order to develop an evidence-based hearing aid selection model.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid Treatments | Experimental | Device: Hearing Aid TreatmentsHearing aid treatments: TC (Traditional Custom), RITA (Receiver-in-the Aid), and RITE (Receiver-in the-Ear) |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sensorineural hearing loss
- Veteran-adult onset of hearing
- English as first language
- Eligible for VA issued hearing aids
- Eligible to receive care at one of the three participating VA sites: Nashville, Tennessee, Mountain Home Tennessee, Bay Pines Florida
Key exclusion criteria (3 listed)
- Known neurological, psychiatric disorders, or co-morbid disease that would prevent completion of the study
- Inadequate vision
- Inadequate reading skills
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 |
|---|---|---|
| Hearing Aid TreatmentsHearing aid treatments: Traditional Custom (TC), Receiver-in-the Aid (RITA) and Receiver-in-the-Ear (RITE) | Device | Hearing Aid Treatments |
Primary outcome
Percentage of Participants That Selected a Particular Type of Hearing Aid
Time frame: At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gene W. Bratt, PhD MA BA principal investigator
VA Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Aid Treatments in people with Hearing Loss, run by US Department of Veterans Affairs at 3 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 3 Jun 2014). 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?
Percentage of Participants That Selected a Particular Type of Hearing Aid (time frame: At the end of the 6 month trial (after having worn each set of hearing aids for 2 months each)). 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 10 Jun 2014.