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The Effectiveness of Over the Counter Hearing Products for Middle-Aged Adults

Not Applicable
Withdrawn
Conditions
Hearing Loss, Functional
Interventions
Device: over-the-counter hearing device
Registration Number
NCT03511417
Lead Sponsor
University of Massachusetts, Amherst
Brief Summary

The investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. Many people are unlikely to pay several thousand dollars for hearing aids but they likely would be more willing to try a possible solution that is less expensive. When faced with counseling these individuals, audiologists are at a loss regarding whether or not to suggest that they try this type of technology, since there is virtually no research available to verify that these devices actually are helpful, particularly for individuals with mild hearing loss. The hypothesis being tested is that personal sound amplifiers can improve functional hearing and decrease cognitive load in complex auditory environments.

Detailed Description

The field trials in this project will require you to use OTC hearing devices for a specified period of time in both ears simultaneously, and in just one ear, with periodic lab-based re-evaluation. Each field trial will continue until asymptotic performance is identified (up to a maximum of 12 weeks). You will return to the lab for assessment every 2 weeks. During each visit, speech perception and subjective listening effort will be assessed. Depending upon the specific field trial, the investigators also will complete measures of cognitive load (via dual-task paradigms), spatial release from masking, and localization ability during each lab visit.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  • Age 40-64 years
  • Mild to moderate high frequency hearing loss
  • Learned English as a first language
Exclusion Criteria
  • Previous use of hearing aids
  • Hearing loss/problems attributed to factors other than aging
  • History of: neurologic disorder, middle-ear disease
  • Score of < 26 on the Montreal Cognitive Assessment

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Middle-aged adultsover-the-counter hearing deviceParticipants will use an over-the-counter hearing device in one ear until asymptotic speech perception performance is noted (maximum 12 weeks). The same individuals will use over-the-counter hearing devices in each ear until asymptotic performance is noted (the order of these two phases will be randomized across participants). They will be asked to use these devices at least 4 hours/day.
Primary Outcome Measures
NameTimeMethod
Speech Perceptionevery two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to understand sentences presented in background noise

Cognitive Loadevery two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to remember speech that has previously been presented in background noise

Localization Abilityevery two weeks until asymptotic performance is noted (up to 12 weeks)

The change in the ability to indicate where a sound is coming from when presented in background noise

Self-Perceived Listening Effortevery two weeks until asymptotic performance is noted (up to 12 weeks)

Changes in how difficult it is to understand speech in background noise

Secondary Outcome Measures
NameTimeMethod
Self-perceived hearing device benefitdaily during field trial (up to 12 weeks)

The situations in which participants find the hearing aids to be beneficial

Overall perceived benefit from hearing deviceevery two weeks until asymptotic performance is noted (up to 12 weeks)

The extent to which participants believe the hearing devices help them

Trial Locations

Locations (1)

University of Massachusetts Amherst

🇺🇸

Amherst, Massachusetts, United States

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