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

Hearing Loss, Functional Clinical Trial

Official title:

Aging and Speech Perception in Complex Listening Environments

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03511417
• Other study ID #: R01DC012057-06
• Status: Withdrawn
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: January 17, 2020

Study information

• Verified date: October 2021
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 17, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss
• Hearing Loss, Functional

Intervention

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

Locations

Country	Name	City	State
United States	University of Massachusetts Amherst	Amherst	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)