MedPath

Patient-Centered Hearing Aid Trial

Not Applicable
Active, not recruiting
Conditions
Hearing Aids
Hearing Loss
Interventions
Device: Hearing Aids
Registration Number
NCT04618315
Lead Sponsor
Northwestern University
Brief Summary

Satisfaction and benefit from hearing aids fit using two patient self fit methods will be compared against those fit using audiology-based best practices. Individuals between the ages of 50 and 79 years of age will be randomly assigned to one of three fitting methods. Benefit and satisfaction will be evaluated six weeks and six months after the initial fitting.

Detailed Description

Hearing aids are the most pertinent treatment for most adults with hearing loss, a pervasive chronic health problem in \~40% of those over the age of 60 years. Only 20% of these individuals purchase and use hearing aids. The Over-the-Counter Hearing Aid Act of 2017 is designed to increase affordability and accessibility, and thereby adoption, of hearing aids. While this legislation directs the Food and Drug Administration (FDA) to create and administer this new channel of hearing aid provision by 2020, best practices related to hearing aid provision without the involvement of a professional, licensed provider have not been explored and established. Patients do not have the evidence they need to decide between modes of acquiring hearing aids. The current proposal addresses the specific knowledge gap of efficacious direct-to-consumer hearing aid delivery models. Two methods of patient-driven methods of selecting and fitting hearing aids will be compared against audiology-based best practice fitting. Individuals who perceive mild or moderate hearing difficulty will be randomly assigned to one of three fitting arms. Satisfaction and benefit from hearing aids will be assessed at six weeks and six months after initial fit.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
584
Inclusion Criteria
  • 50 - 79 years old.
  • Mild or moderate hearing difficulty.
  • Normal cognition.
  • No prior hearing aid experience.
  • Ability and willingness to pay privately ($650.00) for hearing aids
  • Ability to read and understand English
  • Symmetric hearing loss, no greater than moderate in degree
Read More
Exclusion Criteria
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Consumer DecidesHearing AidsHearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying loudness levels.
Efficient FittingHearing AidsHearing aids will be self fit by patients using an interactive application on a tablet computer. Patients will choose their preferred hearing aid settings after comparing four settings with varying base and treble settings.
Audiology-Based Best PracticeHearing AidsHearing aids will be fit using current best practices used by audiologists to fit hearing aids.
Primary Outcome Measures
NameTimeMethod
Profile of Hearing Aid Benefit6 weeks

66-item self-assessment, disability-based inventory.

Secondary Outcome Measures
NameTimeMethod
Hearing Handicap Inventory for the Elderly6 weeks

A self-administered scale to identify problems related to hearing loss.

Trial Locations

Locations (4)

Sertoma Speech and Hearing Center

🇺🇸

Palos Hills, Illinois, United States

Northwestern Memorial Hospital

🇺🇸

Chicago, Illinois, United States

Northwestern University Center for Audiology, Speech, Language, and Learning

🇺🇸

Evanston, Illinois, United States

University of Texas Medical Branch

🇺🇸

Galveston, Texas, United States

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