Clinical trial NCT02772757: Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Official title: Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: hearing loss
hearing aids
outcome assessment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-05-13
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: in Situ Real-ear Aided Response (REAR)
timeFrame: at the visit where in-situ real ear measurements are made (immediate post-fitting)
Secondary outcomes:
measure: Client-Oriented Scale of Improvement (COSI)
timeFrame: 1 month post-fitting
measure: Device Oriented Subjective Outcome (DOSO) Scale
timeFrame: 1 month post-fitting
measure: Satisfaction With Amplification in Daily Life (SADL)
timeFrame: 1 month post-fitting
Other outcomes:
Locations:
city: Mountain Home
country: United States
facility: Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
state: Tennessee
Study officials:
affiliation: Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
name: Sherri L Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: