Comparison of PSAPs in Different Maskers

Personal Amplification Devices in Noise and Speech Maskers

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.

Study Overview

• Status: Completed
• Conditions: Auditory Perception
• Intervention / Treatment: Device: Tweak Focus; Device: IQ Earbuds; Device: Sound World Solutions CS50+; Device: Bose Hearphones

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Amherst, Massachusetts, United States, 01003
      • University of Massachusetts Amherst

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tweak Focus; Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers.	Device: Tweak Focus; Participants will be tested using the Tweak Focus hearing devices.
Experimental: IQ Earbuds; Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers.	Device: IQ Earbuds; Participants will be tested using the IQ Earbuds hearing devices.
Experimental: Sound World Solutions CS50+; Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.	Device: Sound World Solutions CS50+; Participants will be tested using the Sound World Solutions CS 50+ hearing devices.
Experimental: Bose Hearphones; Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers.	Device: Bose Hearphones; Participants will be tested using the Bose Hearphones hearing devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise	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.	One 2-hour lab session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Self-rated Listening Effort	Effect of listening devices on subjective listening effort, measured by rating on ten-point scale (10 = greatest amount of effort) after task performed with device minus rating after task performed without device. Lower scores indicate less listening effort; negative values indicate reduction in effort with device.	One 2-hour session

Collaborators and Investigators

• Sponsor: University of Massachusetts, Amherst

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UMassAmherst

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No