Coupler-Based Hearing-Aid Fitting Approach for Experienced Users

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02772757
• Other study ID #: C1895-P
• Status: Completed
• Phase: N/A
• Start date: January 4, 2016
• Est. completion date: December 29, 2017

Study information

• Verified date: February 2019
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 29, 2017
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss

Intervention

Behavioral:
• standard hearing aid fitting
standard hearing aid, face-to-face fitting
• coupler-based fitting
coupler-based fitting using average RECDs
• coupler-based fitting
coupler-based fitting using measured RECDs

Locations

Country	Name	City	State
United States	Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN	Mountain Home	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in Situ Real-ear Aided Response (REAR)	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).	at the visit where in-situ real ear measurements are made (immediate post-fitting)
Secondary	Client-Oriented Scale of Improvement (COSI)	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.	1 month post-fitting
Secondary	Device Oriented Subjective Outcome (DOSO) Scale	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).	1 month post-fitting
Secondary	Satisfaction With Amplification in Daily Life (SADL)	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).	1 month post-fitting

External Links

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