Hearing LossNCT02772757
Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
A study testing standard hearing aid fitting and coupler-based fitting in people with Hearing Loss, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- standard hearing aid fitting and coupler-based fitting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2016to 29 Dec 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- no more than a moderate sensorineural hearing loss (defined as < 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
- experienced BTE hearing-aid users who are obtaining replacement VA-issued BTE hearing aids coupled to a custom earmold that is simply an upgrade in model with the same style earmold
- ability to read and write in English as determined by reading a few sentences from the consent document aloud so that self-report measures can be completed
Who cannot join
- outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
- lack of phone or non-use of the phone as the participants will be required to conduct a telephone interview after they obtain their replacement hearing aids
- unwilling or unable to be mailed hearing aids
- co-morbid condition that would preclude their participation as determined by a chart review
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, 37684
About this study
Official title: Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. If the coupler-based fitting protocol tested in this study as effective as the traditional fitting protocol, then patients receiving replacement hearing aids may circumvent a face-to-face visit.
Read the detailed description
This study will incorporate a verification technique that simulates the patient's actual ear during probe microphone verification measurements, called real-ear to coupler difference (RECD). Because the patient's ear is not used during the RECD measurement, but rather simulated, the patient would not need to be present during the RECD verification. This RECD hearing aid verification can occur in the clinic after which the hearing aids will be mailed to the patient. This study will compare the fitting accuracy and outcomes between the two approaches.
- Conditions
- Hearing Loss
- Being tested
- standard hearing aid fitting, coupler-based fitting
- Keywords
- hearing loss, hearing aids, outcome assessment
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard hearing aid fittingBehavioural
standard hearing aid, face-to-face fitting
coupler-based fittingBehavioural
coupler-based fitting using average RECDs
coupler-based fittingBehavioural
coupler-based fitting using measured RECDs
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care group | Active comparator | Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach Receives: Behavioral: standard hearing aid fitting |
| Average RECD group | Experimental | This group will have their hearing aid fitting via the coupler using average RECD values during the fitting Receives: Behavioral: coupler-based fitting |
| Measured RECD group | Experimental | This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting Receives: Behavioral: coupler-based fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
in Situ Real-ear Aided Response (REAR)
Deviation from prescriptive target (re: in situ REAR) from both ears of each participant for each group. This measure reflects the accuracy of the hearing aid fittings from 250 Hz through 3000 Hz (the average bandwidth of audibility).
Measured: at the visit where in-situ real ear measurements are made (immediate post-fitting)
Secondary outcomes (3)
Client-Oriented Scale of Improvement (COSI)
The listener nominates up to five listening goals. 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 5 unit categorical scale from 'worse' to 'much better'. The second outcome is the final satisfactory 'aided' ability for each goal as measured on a 5 unit categorical scale from hardy ever (10%) to almost always (95%). Higher scores reflect better outcomes for nominated goals. We calculated the percent of better and much better responses over the nominated goals and the average satisfactory aided ability over the nominated goals.
Measured: 1 month post-fitting
Device Oriented Subjective Outcome (DOSO) Scale
The questionnaire is comprised of 28 items making up the following six subscales related to listening performance with hearing aids: (1) speech cues, (2) listening effort, (3) pleasantness, (4) quietness, (5) convenience, and (6) use. Responses from 'not at all' (1 point) to tremendously (7 points) are recorded for each item and are averaged across all items to obtain a total scale score. Higher scores reflect higher outcomes. The minimum and maximum total scores can range from 1-7 and for the three groups were: standard of care group (3.8-6.8), Average RECD group (3.3-6.7), and measured RCD group (3.8-6.5).
Measured: 1 month post-fitting
Satisfaction With Amplification in Daily Life (SADL)
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. Item 14 is omitted in populations who do not pay for hearing aids. Responses are on a 1 to 7 scale with higher numbers reflecting higher outcomes. The item responses are averaged to determine the total satisfaction score that can range from 1-7. The minimum and maximum total scores for the three groups were: standard of care group (5.1-7.0); average RECD group (4.2-6.9), and measured RECD group (4.9-7.0).
Measured: 1 month post-fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study start4 Jan 2016
- Primary completion1 May 2017
- Study completion29 Dec 2017
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
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Sherri L Smith, PhD, Principal investigator, Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772757
- Sponsor's protocol ID
- C1895-P
- Status last verified
- Feb 2019
- First submitted
- 2 May 2016
- Last updated
- 10 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
- ClinicalTrials.gov ID
- NCT02772757
- Acronym / sponsor ID
- C1895-P
- Conditions
- Hearing Loss
- Keywords
- hearing loss, hearing aids, outcome assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Jan 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 29 Dec 2017 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall aim of the study is to compare the verification accuracy and hearing-aid outcomes between the traditional, fitting approach where the patient is present during the visit and a coupler-based fitting approach where the patient is not present and mailed their hearing aids. If the coupler-based fitting protocol tested in this study as effective as the traditional fitting protocol, then patients receiving replacement hearing aids may circumvent a face-to-face visit.
Detailed description
This study will incorporate a verification technique that simulates the patient's actual ear during probe microphone verification measurements, called real-ear to coupler difference (RECD). Because the patient's ear is not used during the RECD measurement, but rather simulated, the patient would not need to be present during the RECD verification. This RECD hearing aid verification can occur in the clinic after which the hearing aids will be mailed to the patient. This study will compare the fitting accuracy and outcomes between the two approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care group | Active comparator | Behavioral: standard hearing aid fittingStandard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach |
| Average RECD group | Experimental | Behavioral: coupler-based fittingThis group will have their hearing aid fitting via the coupler using average RECD values during the fitting |
| Measured RECD group | Experimental | Behavioral: coupler-based fittingThis group will have their hearing aid fitting via the coupler using measured RECD values during the fitting |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- no more than a moderate sensorineural hearing loss (defined as < 60 dB HL pure-tone average at 500, 1000, and 2000 Hz AU)
- experienced BTE hearing-aid users who are obtaining replacement VA-issued BTE hearing aids coupled to a custom earmold that is simply an upgrade in model with the same style earmold
- ability to read and write in English as determined by reading a few sentences from the consent document aloud so that self-report measures can be completed
Key exclusion criteria (4 listed)
- outer or middle ear pathology as determined by otoscopy, immittance, and/or audiometric testing (e.g., conductive or mixed losses)
- lack of phone or non-use of the phone as the participants will be required to conduct a telephone interview after they obtain their replacement hearing aids
- unwilling or unable to be mailed hearing aids
- co-morbid condition that would preclude their participation as determined by a chart review
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 |
|---|---|---|
| standard hearing aid fittingstandard hearing aid, face-to-face fitting | Behavioural | Standard of Care group |
| coupler-based fittingcoupler-based fitting using average RECDs | Behavioural | Average RECD group |
| coupler-based fittingcoupler-based fitting using measured RECDs | Behavioural | Measured RECD group |
Primary outcome
in Situ Real-ear Aided Response (REAR)
Time frame: at the visit where in-situ real ear measurements are made (immediate post-fitting)
Deviation from prescriptive target (re: in situ REAR) from both ears of each participant for each group. This measure reflects the accuracy of the hearing aid fittings from 250 Hz through 3000 Hz (the average bandwidth of audibility).
3 secondary outcomes
Client-Oriented Scale of Improvement (COSI)
Time frame: 1 month post-fitting
Device Oriented Subjective Outcome (DOSO) Scale
Time frame: 1 month post-fitting
Satisfaction With Amplification in Daily Life (SADL)
Time frame: 1 month post-fitting
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Click here for more information about this study: Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced UsersLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Sherri L Smith, PhD principal investigator
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard hearing aid fitting and coupler-based fitting 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 3 inclusion and 4 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 May 2019. 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 10 May 2019). 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?
in Situ Real-ear Aided Response (REAR) (time frame: at the visit where in-situ real ear measurements are made (immediate post-fitting)). 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 May 2019.