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

NCT03511417 | Withdrawn

• 1 other identifier: R01DC012057-06
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss, Functional

Outcome Measures

Primary Outcomes (4)

• Speech Perception

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

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

• Cognitive Load

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

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

• Localization Ability

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

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

• Self-Perceived Listening Effort

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

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

Secondary Outcomes (2)

• Self-perceived hearing device benefit

  daily during field trial (up to 12 weeks)

• Overall perceived benefit from hearing device

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

Study Arms (1)

Middle-aged adults

EXPERIMENTAL

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.

Device: over-the-counter hearing device

Interventions

over-the-counter hearing device DEVICE

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

Middle-aged adults

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 40-64 years
• Mild to moderate high frequency hearing loss
• Learned English as a first language

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Amherst: lead

Study Sites (1)

University of Massachusetts Amherst

Amherst, Massachusetts, 01003, United States

Location

MeSH Terms

Conditions

Hearing Loss, Functional

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 27, 2018
• Study Start: October 16, 2018
• Primary Completion: January 17, 2020
• Study Completion: January 17, 2020
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)