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

Aging and Speech Perception in Complex Listening Environments

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.

Study Overview

• Status: Withdrawn
• Conditions: Hearing Loss, Functional
• Intervention / Treatment: Device: over-the-counter hearing device

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • University of Massachusetts Amherst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-perceived hearing device benefit	The situations in which participants find the hearing aids to be beneficial	daily during field trial (up to 12 weeks)
Overall perceived benefit from hearing device	The extent to which participants believe the hearing devices help them	every two weeks until asymptotic performance is noted (up to 12 weeks)

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2018
• Primary Completion (Actual): January 17, 2020
• Study Completion (Actual): January 17, 2020

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 20, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Hearing Loss, Functional
• Other Study ID Numbers: R01DC012057-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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