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

Primary Purpose

Hearing Loss, Functional

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
over-the-counter hearing device
Sponsored by
University of Massachusetts, Amherst
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Functional

Eligibility Criteria

40 Years - 64 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Massachusetts Amherst

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Middle-aged adults

Arm Description

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.

Outcomes

Primary Outcome Measures

Speech Perception
The change in the ability to understand sentences presented in background noise
Cognitive Load
The change in the ability to remember speech that has previously been presented in background noise
Localization Ability
The change in the ability to indicate where a sound is coming from when presented in background noise
Self-Perceived Listening Effort
Changes in how difficult it is to understand speech in background noise

Secondary Outcome Measures

Self-perceived hearing device benefit
The situations in which participants find the hearing aids to be beneficial
Overall perceived benefit from hearing device
The extent to which participants believe the hearing devices help them

Full Information

First Posted
April 9, 2018
Last Updated
October 12, 2021
Sponsor
University of Massachusetts, Amherst
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1. Study Identification

Unique Protocol Identification Number
NCT03511417
Brief Title
The Effectiveness of Over the Counter Hearing Products for Middle-Aged Adults
Official Title
Aging and Speech Perception in Complex Listening Environments
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Due to the delay in establishing FDA regulations for over-the-counter hearing aids
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
January 17, 2020 (Actual)
Study Completion Date
January 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Amherst

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Functional

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Middle-aged adults
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
over-the-counter hearing device
Intervention Description
Individuals will use commercially-available over-the-counter hearing devices for specified periods of time.
Primary Outcome Measure Information:
Title
Speech Perception
Description
The change in the ability to understand sentences presented in background noise
Time Frame
every two weeks until asymptotic performance is noted (up to 12 weeks)
Title
Cognitive Load
Description
The change in the ability to remember speech that has previously been presented in background noise
Time Frame
every two weeks until asymptotic performance is noted (up to 12 weeks)
Title
Localization Ability
Description
The change in the ability to indicate where a sound is coming from when presented in background noise
Time Frame
every two weeks until asymptotic performance is noted (up to 12 weeks)
Title
Self-Perceived Listening Effort
Description
Changes in how difficult it is to understand speech in background noise
Time Frame
every two weeks until asymptotic performance is noted (up to 12 weeks)
Secondary Outcome Measure Information:
Title
Self-perceived hearing device benefit
Description
The situations in which participants find the hearing aids to be beneficial
Time Frame
daily during field trial (up to 12 weeks)
Title
Overall perceived benefit from hearing device
Description
The extent to which participants believe the hearing devices help them
Time Frame
every two weeks until asymptotic performance is noted (up to 12 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Massachusetts Amherst
City
Amherst
State/Province
Massachusetts
ZIP/Postal Code
01003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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