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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tweak Focus | Experimental | Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers. |
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| IQ Earbuds | Experimental | Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers. |
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| Sound World Solutions CS50+ | Experimental | Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. |
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| Bose Hearphones | Experimental | Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sound World Solutions CS50+ | Device | Participants will be tested using the Sound World Solutions CS 50+ hearing devices. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Amherst | Amherst | Massachusetts | 01003 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | IQ Earbuds |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Percent of words recalled | One 2-hour lab session |
|
Lab visit (1-3 hours)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Helfer | University of Massachusetts Amherst Dept. of Communication Disorders | 413-545-4014 | khelfer@comdis.umass.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 28, 2022 | Feb 28, 2022 | Prot_SAP_ICF_000.pdf |
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Each participant will be tested with one of the models of devices.
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| Tweak Focus | Device | Participants will be tested using the Tweak Focus hearing devices. |
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| IQ Earbuds | Device | Participants will be tested using the IQ Earbuds hearing devices. |
|
| Bose Hearphones | Device | Participants will be tested using the Bose Hearphones hearing devices. |
|
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.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hearing loss (better-ear high-frequency pure tone average) | Level of hearing loss, determined by puretone audiometry; average hearing loss in better ear for frequencies 2000-6000 Herz | Mean | Standard Deviation | Decibels Hearing Loss |
|
| OG002 | IQ Buds | Group of participants who were assigned the Nuheara IQ Buds listening device |
| OG003 | Bose | Group of participants who were assigned the Bose Hearphones listening device |
|
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| 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. | Posted | Mean | Standard Deviation | Units on a scale | One 2-hour session |
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| 10 |
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| 10 |
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| 10 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | 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. | 0 | 10 | 0 | 10 | 0 | 10 |
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