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

• Sponsor: University of Massachusetts, Amherst (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT03511417
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arm: 1
• Actual Duration (Months): 15
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Functional	Device: over-the-counter hearing device	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Aging and Speech Perception in Complex Listening Environments
• Actual Study Start Date: Oct 16, 2018
• Actual Primary Completion Date: Jan 17, 2020
• Actual Study Completion Date: Jan 17, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Speech Perception [every two weeks until asymptotic performance is noted (up to 12 weeks)]

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

2. Cognitive Load [every 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

3. Localization Ability [every 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

4. Self-Perceived Listening Effort [every two weeks until asymptotic performance is noted (up to 12 weeks)]

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

Secondary Outcome Measures

1. Self-perceived hearing device benefit [daily during field trial (up to 12 weeks)]

   The situations in which participants find the hearing aids to be beneficial

2. Overall perceived benefit from hearing device [every two weeks until asymptotic performance is noted (up to 12 weeks)]

   The extent to which participants believe the hearing devices help them

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Massachusetts Amherst	Amherst	Massachusetts	United States	01003

Sponsors and Collaborators

• University of Massachusetts, Amherst

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Karen Helfer, Professor and Chair, University of Massachusetts, Amherst
• ClinicalTrials.gov Identifier: NCT03511417
• Other Study ID Numbers: R01DC012057-06
• First Posted: Apr 27, 2018
• Last Update Posted: Oct 20, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Hearing Loss; Hearing Loss, Functional

Study Results

No Results Posted as of Oct 20, 2021