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

Study Overview
=================
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.

Official Title
-----------------
Aging and Speech Perception in Complex Listening Environments

Conditions
-----------------
Hearing Loss, Functional

Intervention / Treatment
-----------------
* Device: over-the-counter hearing device


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Middle-aged adults<br>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<br>* Individuals will use commercially-available over-the-counter hearing devices for specified periods of time.<br>|

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) |