Coupler-Based Hearing-Aid Fitting Approach for Experienced Users

• ClinicalTrials.gov Identifier: NCT02772757
• Recruitment Status: Completed
• First Posted: May 13, 2016
• Results First Posted: May 10, 2019
• Last Update Posted: May 10, 2019
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hearing Loss	Behavioral: standard hearing aid fitting; Behavioral: coupler-based fitting	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users
• Actual Study Start Date: January 4, 2016
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: December 29, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Standard of Care group; Standard of Care group will receive the standard, face-to-face hearing aid fitting and verification approach	Behavioral: standard hearing aid fitting; standard hearing aid, face-to-face fitting
Experimental: Average RECD group; This group will have their hearing aid fitting via the coupler using average RECD values during the fitting	Behavioral: coupler-based fitting; coupler-based fitting using average RECDs
Experimental: Measured RECD group; This group will have their hearing aid fitting via the coupler using measured RECD values during the fitting	Behavioral: coupler-based fitting; coupler-based fitting using measured RECDs

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Client-Oriented Scale of Improvement (COSI) [ Time Frame: 1 month post-fitting ]
   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.
2. Device Oriented Subjective Outcome (DOSO) Scale [ Time Frame: 1 month post-fitting ]
   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).
3. Satisfaction With Amplification in Daily Life (SADL) [ Time Frame: 1 month post-fitting ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Tennessee

Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

Mountain Home, Tennessee, United States, 37684

Sponsors and Collaborators

VA Office of Research and Development

Investigators

• Principal Investigator: Sherri L Smith, PhD; Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN

  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:

Study Protocol and Statistical Analysis Plan  [PDF] April 30, 2015

More Information

Additional Information:

Click here for more information about this study: Efficacy of a Coupler-Based Hearing-Aid Fitting Approach for Experienced Users 

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT02772757
• Other Study ID Numbers: C1895-P
• First Posted: May 13, 2016
• Results First Posted: May 10, 2019
• Last Update Posted: May 10, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

hearing loss; hearing aids; outcome assessment

Additional relevant MeSH terms:

Hearing Loss; Deafness; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases