Trial Outcomes & Findings for Comparison of PSAPs in Different Maskers (NCT NCT03704142)
NCT ID: NCT03704142
Last Updated: 2022-05-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
One 2-hour lab session
Results posted on
2022-05-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of PSAPs in Different Maskers
Baseline characteristics by cohort
| Measure |
Tweak Focus
n=10 Participants
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.
|
IQ Earbuds
n=10 Participants
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.
|
Sound World Solutions CS50+
n=10 Participants
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.
|
Bose Hearphones
n=10 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
58.6 Years
STANDARD_DEVIATION 4.01 • n=99 Participants
|
58.4 Years
STANDARD_DEVIATION 5.46 • n=107 Participants
|
59.6 Years
STANDARD_DEVIATION 4.06 • n=206 Participants
|
57 Years
STANDARD_DEVIATION 4.11 • n=7 Participants
|
58.4 Years
STANDARD_DEVIATION 4.38 • n=31 Participants
|
|
Sex/Gender, Customized
Reported gender · Female
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Reported gender · Male
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=31 Participants
|
|
Sex/Gender, Customized
Reported gender · Other/not reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
10 participants
n=107 Participants
|
10 participants
n=206 Participants
|
10 participants
n=7 Participants
|
40 participants
n=31 Participants
|
|
Hearing loss (better-ear high-frequency pure tone average)
|
22 Decibels Hearing Loss
STANDARD_DEVIATION 13.41 • n=99 Participants
|
23.5 Decibels Hearing Loss
STANDARD_DEVIATION 9.57 • n=107 Participants
|
23.5 Decibels Hearing Loss
STANDARD_DEVIATION 11.13 • n=206 Participants
|
20.13 Decibels Hearing Loss
STANDARD_DEVIATION 13.83 • n=7 Participants
|
22.28 Decibels Hearing Loss
STANDARD_DEVIATION 11.72 • n=31 Participants
|
PRIMARY outcome
Timeframe: One 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.
Outcome measures
| Measure |
Tweak Focus
n=10 Participants
Group of participants assigned to use the Tweak Focus hearing device
|
CS50+
n=10 Participants
Group of participants who were assigned the Sound World Solutions CS50+ listening device
|
IQ Buds
n=10 Participants
Group of participants who were assigned the Nuheara IQ Buds listening device
|
Bose
n=10 Participants
Group of participants who were assigned the Bose Hearphones listening device
|
|---|---|---|---|---|
|
Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise
|
1.65 Percent of words recalled
Standard Deviation 6.40
|
0.85 Percent of words recalled
Standard Deviation 7.01
|
7.35 Percent of words recalled
Standard Deviation 6.03
|
10.24 Percent of words recalled
Standard Deviation 8.23
|
SECONDARY outcome
Timeframe: One 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.
Outcome measures
| Measure |
Tweak Focus
n=10 Participants
Group of participants assigned to use the Tweak Focus hearing device
|
CS50+
n=10 Participants
Group of participants who were assigned the Sound World Solutions CS50+ listening device
|
IQ Buds
n=10 Participants
Group of participants who were assigned the Nuheara IQ Buds listening device
|
Bose
n=10 Participants
Group of participants who were assigned the Bose Hearphones listening device
|
|---|---|---|---|---|
|
Difference in Self-rated Listening Effort
|
-1.4 Units on a scale
Standard Deviation 1.26
|
-1.4 Units on a scale
Standard Deviation 1.84
|
-0.9 Units on a scale
Standard Deviation 1.29
|
-1.8 Units on a scale
Standard Deviation 1.81
|
Adverse Events
Tweak Focus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IQ Earbuds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sound World Solutions CS50+
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bose Hearphones
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Karen Helfer
University of Massachusetts Amherst Dept. of Communication Disorders
Phone: 413-545-4014
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place