Patient-Centered Hearing Aid Trial

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    591
  • sponsor
    Northwestern University
Updated on 2 February 2021

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.

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.

Details
Condition Deafness, Hearing Loss, Hearing aid, Auditory Loss and Deafness, Hearing Impairment, decreased hearing, hard of hearing, hypoacusis
Treatment Hearing aids
Clinical Study IdentifierNCT04618315
SponsorNorthwestern University
Last Modified on2 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 50 yrs and 79 yrs?
Gender: Male or Female
Do you have any of these conditions: hypoacusis or Auditory Loss and Deafness or hard of hearing or Hearing Loss or Hearing aid or Deafness or decreased hearing or Hearing Impairment?
Do you have any of these conditions: hypoacusis or Hearing aid or Auditory Loss and Deafness or Deafness or decreased hearing or hard of hearing or Hearing Loss or Hearing Impairment?
- 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

Exclusion Criteria

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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