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Comparison of PSAPs in Different Maskers

Personal Amplification Devices in Noise and Speech Maskers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03704142
Enrollment
48
Registered
2018-10-12
Start date
2019-03-01
Completion date
2020-03-30
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Perception

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.

Interventions

DEVICESound World Solutions CS50+

Participants will be tested using the Sound World Solutions CS 50+ hearing devices.

DEVICETweak Focus

Participants will be tested using the Tweak Focus hearing devices.

DEVICEIQ Earbuds

Participants will be tested using the IQ Earbuds hearing devices.

DEVICEBose Hearphones

Participants will be tested using the Bose Hearphones hearing devices.

Sponsors

University of Massachusetts, Amherst
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Each participant will be tested with one of the models of devices.

Eligibility

Sex/Gender
ALL
Age
45 Years to 64 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in NoiseOne 2-hour lab sessionImprovement 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

MeasureTime frameDescription
Difference in Self-rated Listening EffortOne 2-hour sessionEffect 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Tweak Focus
Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers. Tweak Focus: Participants will be tested using the Tweak Focus hearing devices.
10
IQ Earbuds
Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers. IQ Earbuds: Participants will be tested using the IQ Earbuds hearing devices.
10
Sound World Solutions CS50+
Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. Sound World Solutions CS50+: Participants will be tested using the Sound World Solutions CS 50+ hearing devices.
10
Bose Hearphones
Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. Bose Hearphones: Participants will be tested using the Bose Hearphones hearing devices.
10
Total40

Baseline characteristics

CharacteristicTweak FocusIQ EarbudsSound World Solutions CS50+Bose HearphonesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants10 Participants10 Participants40 Participants
Age, Continuous58.6 Years
STANDARD_DEVIATION 4.01
58.4 Years
STANDARD_DEVIATION 5.46
59.6 Years
STANDARD_DEVIATION 4.06
57 Years
STANDARD_DEVIATION 4.11
58.4 Years
STANDARD_DEVIATION 4.38
Hearing loss (better-ear high-frequency pure tone average)22 Decibels Hearing Loss
STANDARD_DEVIATION 13.41
23.5 Decibels Hearing Loss
STANDARD_DEVIATION 9.57
23.5 Decibels Hearing Loss
STANDARD_DEVIATION 11.13
20.13 Decibels Hearing Loss
STANDARD_DEVIATION 13.83
22.28 Decibels Hearing Loss
STANDARD_DEVIATION 11.72
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants10 Participants10 Participants10 Participants40 Participants
Region of Enrollment
United States
10 participants10 participants10 participants10 participants40 participants
Sex/Gender, Customized
Reported gender
Female
5 Participants9 Participants7 Participants6 Participants27 Participants
Sex/Gender, Customized
Reported gender
Male
5 Participants0 Participants3 Participants4 Participants12 Participants
Sex/Gender, Customized
Reported gender
Other/not reported
0 Participants1 Participants0 Participants0 Participants1 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 100 / 100 / 10
other
Total, other adverse events
0 / 100 / 100 / 100 / 10
serious
Total, serious adverse events
0 / 100 / 100 / 100 / 10

Outcome results

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.

Time frame: One 2-hour lab session

ArmMeasureValue (MEAN)Dispersion
Tweak FocusComparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise1.65 Percent of words recalledStandard Deviation 6.4
CS50+Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise0.85 Percent of words recalledStandard Deviation 7.01
IQ BudsComparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise7.35 Percent of words recalledStandard Deviation 6.03
BoseComparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise10.24 Percent of words recalledStandard Deviation 8.23
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.

Time frame: One 2-hour session

ArmMeasureValue (MEAN)Dispersion
Tweak FocusDifference in Self-rated Listening Effort-1.4 Units on a scaleStandard Deviation 1.26
CS50+Difference in Self-rated Listening Effort-1.4 Units on a scaleStandard Deviation 1.84
IQ BudsDifference in Self-rated Listening Effort-0.9 Units on a scaleStandard Deviation 1.29
BoseDifference in Self-rated Listening Effort-1.8 Units on a scaleStandard Deviation 1.81

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026