Coupler-Based Hearing-Aid Fitting Approach for Experienced Users

VA Office of Research and Development

Status: Completed

Conditions: Hearing Loss

Treatments: Behavioral: standard hearing aid fitting; Behavioral: coupler-based fitting

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02772757

C1895-P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 3 patient groups

Standard of Care group

Active Comparator group

Description:

Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach

Treatment:

Behavioral: standard hearing aid fitting

Average RECD group

Experimental group

Description:

This group will have their hearing aid fitting via the coupler using average RECD values during the fitting

Treatment:

Behavioral: coupler-based fitting

Behavioral: coupler-based fitting

Measured RECD group

Experimental group

Description:

This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting

Treatment:

Behavioral: coupler-based fitting

Behavioral: coupler-based fitting