Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Hearing Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 85 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT03569228
Collaborators
Not Provided
Investigators
Principal Investigator: Sherri Lyn Smith, PhD Durham VA Medical Center, Durham, NC