Clinical trial NCT03511417: The Effectiveness of Over the Counter Hearing Products for Middle-Aged Adults
Official title: Aging and Speech Perception in Complex Listening Environments
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss, Functional
Lead sponsor: University of Massachusetts, Amherst
Sponsor class: OTHER
First posted: 2018-04-27
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Speech Perception
timeFrame: every two weeks until asymptotic performance is noted (up to 12 weeks)
measure: Cognitive Load
timeFrame: every two weeks until asymptotic performance is noted (up to 12 weeks)
measure: Localization Ability
timeFrame: every two weeks until asymptotic performance is noted (up to 12 weeks)
measure: Self-Perceived Listening Effort
timeFrame: every two weeks until asymptotic performance is noted (up to 12 weeks)
Secondary outcomes:
measure: Self-perceived hearing device benefit
timeFrame: daily during field trial (up to 12 weeks)
measure: Overall perceived benefit from hearing device
timeFrame: every two weeks until asymptotic performance is noted (up to 12 weeks)
Other outcomes:
Locations:
city: Amherst
country: United States
facility: University of Massachusetts Amherst
state: Massachusetts
Study officials:
References: