Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02772757|
Recruitment Status : Completed
First Posted : May 13, 2016
Results First Posted : May 10, 2019
Last Update Posted : May 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss||Behavioral: standard hearing aid fitting Behavioral: coupler-based fitting||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users|
|Actual Study Start Date :||January 4, 2016|
|Actual Primary Completion Date :||May 1, 2017|
|Actual Study Completion Date :||December 29, 2017|
Active Comparator: Standard of Care group
Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach
Behavioral: standard hearing aid fitting
standard hearing aid, face-to-face fitting
Experimental: Average RECD group
This group will have their hearing aid fitting via the coupler using average RECD values during the fitting
Behavioral: coupler-based fitting
coupler-based fitting using average RECDs
Experimental: Measured RECD group
This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting
Behavioral: coupler-based fitting
coupler-based fitting using measured RECDs
- 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).
- Client-Oriented Scale of Improvement (COSI) [ Time Frame: 1 month post-fitting ]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.
- Device Oriented Subjective Outcome (DOSO) Scale [ Time Frame: 1 month post-fitting ]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).
- Satisfaction With Amplification in Daily Life (SADL) [ Time Frame: 1 month post-fitting ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772757
|United States, Tennessee|
|Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN|
|Mountain Home, Tennessee, United States, 37684|
|Principal Investigator:||Sherri L Smith, PhD||Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN|