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Clinical Trials/NCT02772757
NCT02772757
Completed
Not Applicable

Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users

VA Office of Research and Development1 site in 1 country77 target enrollmentJanuary 4, 2016
ConditionsHearing Loss

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hearing Loss
Sponsor
VA Office of Research and Development
Enrollment
77
Locations
1
Primary Endpoint
in Situ Real-ear Aided Response (REAR)
Status
Completed
Last Updated
6 years ago

Overview

Brief 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. 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.

Registry
clinicaltrials.gov
Start Date
January 4, 2016
End Date
December 29, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Device Oriented Subjective Outcome (DOSO) Scale(1 month post-fitting)
  • Client-Oriented Scale of Improvement (COSI)(1 month post-fitting)
  • Satisfaction With Amplification in Daily Life (SADL)(1 month post-fitting)

Study Sites (1)

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