NCT02772757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 4, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 10, 2019

Completed
Last Updated

May 10, 2019

Status Verified

February 1, 2019

Enrollment Period

1.3 years

First QC Date

May 2, 2016

Results QC Date

May 7, 2018

Last Update Submit

February 7, 2019

Conditions

Hearing Loss

Keywords

hearing losshearing aidsoutcome assessment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Client-Oriented Scale of Improvement (COSI)

    1 month post-fitting

  • Device Oriented Subjective Outcome (DOSO) Scale

    1 month post-fitting

  • Satisfaction With Amplification in Daily Life (SADL)

    1 month post-fitting

Study Arms (3)

Standard of Care group

ACTIVE COMPARATOR

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

Behavioral: standard hearing aid fitting

Average RECD group

EXPERIMENTAL

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

Behavioral: coupler-based fitting

Measured RECD group

EXPERIMENTAL

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

Behavioral: coupler-based fitting

Interventions

standard hearing aid fittingBEHAVIORAL

standard hearing aid, face-to-face fitting

Standard of Care group
coupler-based fittingBEHAVIORAL

coupler-based fitting using average RECDs

Average RECD group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mountain Home, Tennessee, 37684, United States

Location

Related Links

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Pilot study limited to one style of hearing aids.

Results Point of Contact

Title
Sherri L. Smith, Au.D., Ph.D.
Organization
Mountain Home VA Medical Center
sherri.smith@va.gov
423.926.1171

Study Officials

  • Sherri L Smith, PhD

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

May 13, 2016

Study Start

January 4, 2016

Primary Completion

May 1, 2017

Study Completion

December 29, 2017

Last Updated

May 10, 2019

Results First Posted

May 10, 2019

Record last verified: 2019-02

Locations

US(1)