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

University of Massachusetts, Amherst

Status: Withdrawn

Conditions: Hearing Loss, Functional

Treatments: Device: over-the-counter hearing device

Study type: Interventional

Funder types: Other

Identifiers

NCT03511417

R01DC012057-06

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 40 to 64 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Middle-aged adults

Experimental group

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.

Treatment:

Device: over-the-counter hearing device