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

Aging and Speech Perception in Complex Listening Environments

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03511417
Enrollment
0
Registered
2018-04-27
Start date
2018-10-16
Completion date
2020-01-17
Last updated
2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Loss, Functional

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.

Interventions

DEVICEover-the-counter hearing device

Individuals will use commercially-available over-the-counter hearing devices for specified periods of time.

Sponsors

University of Massachusetts, Amherst
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 64 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026