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Clinical Trials/NCT03704142
NCT03704142CompletedNot Applicable

Personal Amplification Devices in Noise and Speech Maskers

University of Massachusetts, Amherst1 site in 1 country48 target enrollmentStarted: March 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise

Study Overview

Brief Summary

This study will measure the performance of three personal amplification devices when used by middle-aged adults. Speech understanding will be assessed with two different types of background noises at three different input levels.

Detailed Description

Speech understanding will be measured both unaided and aided with three different models of Personal Amplification devices (PSAPs). Sentences will be played to the participant from a loudspeaker located in front. Different types of background sounds (noise and other sentences) will be played from loudspeakers located to the right and left of the participant. Participants will be instructed to repeat back the sentence coming from the front. They also will rate subjective effort at the end of each block of trials.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •mild high-frequency hearing loss (pure-tone thresholds of 25 decibels hearing loss - 45 decibels hearing loss between 2000 Hz and 6000 Hz)

Exclusion Criteria

  • •history of prior hearing aid use
  • •history of neurologic or otologic disorders
  • •score of < 26 on Montreal Cognitive Assessment (cognitive screening tool)

Arms & Interventions

Tweak Focus

Experimental

Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers.

Intervention: Tweak Focus (Device)

IQ Earbuds

Experimental

Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers.

Intervention: IQ Earbuds (Device)

Sound World Solutions CS50+

Experimental

Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.

Intervention: Sound World Solutions CS50+ (Device)

Bose Hearphones

Experimental

Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.

Intervention: Bose Hearphones (Device)

Outcomes

Primary Outcomes

Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise

Time Frame: One 2-hour lab session

Improvement in performance on speech perception task using the Nuheara IQ Buds, Tweak Focus, Bose Hearphones, or the Sound World Solutions CS 50+ personal listening devices, measured by percentage of words accurately recalled in noise with device minus percentage recalled without device. Positive values indicate improvement in performance.

Secondary Outcomes

  • Difference in Self-rated Listening Effort(One 2-hour session)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Karen Helfer

Principal Investigator

University of Massachusetts, Amherst

Study Sites (1)

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