Comparison of PSAPs in Different Maskers

Auditory Perception Clinical Trial

Official title:

Personal Amplification Devices in Noise and Speech Maskers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03704142
• Other study ID #: UMassAmherst
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: February 2022
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 64 Years

Eligibility

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)

Related Conditions & MeSH terms

• Auditory Perception

Intervention

Device:
• Sound World Solutions CS50+
Participants will be tested using the Sound World Solutions CS 50+ hearing devices.
• Tweak Focus
Participants will be tested using the Tweak Focus hearing devices.
• IQ Earbuds
Participants will be tested using the IQ Earbuds hearing devices.
• Bose Hearphones
Participants will be tested using the Bose Hearphones hearing devices.

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	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	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