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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
standard hearing aid, face-to-face fitting
coupler-based fitting using average RECDs
coupler-based fitting using measured RECDs
Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
Mountain Home, Tennessee, United States
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).
Time frame: at the visit where in-situ real ear measurements are made (immediate post-fitting)
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.
Time frame: 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).
Time frame: 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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1 month post-fitting