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

NCT ID: NCT03511417

Last Updated: 2021-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2020-01-17

Brief Summary

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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

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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.

Conditions

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Hearing Loss, Functional

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Middle-aged adults

Participants 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.

Group Type EXPERIMENTAL

over-the-counter hearing device

Intervention Type DEVICE

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

Interventions

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over-the-counter hearing device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Massachusetts, Amherst

OTHER

Sponsor Role lead

Responsible Party

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Karen Helfer

Professor and Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Massachusetts Amherst

Amherst, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01DC012057-06

Identifier Type: NIH

Identifier Source: org_study_id

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