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This study will compare different microphone technologies in a noisy environment when the dominant speaker is at the front, back, left, or right side of the listener.
Understanding speech in a noisy environment can be difficult for people with hearing loss even with hearing aids. Hearing aid manufacturers have implanted various methods (i.e., directional micro-phones, noise reduction, noise cancelers) to try to improve the signal-to-noise ratio (SNR) to increase the speech understanding in these difficult listening situations.
This study is evaluating different microphone technologies to determine listening effort when speech is to the back or side of the listener in noisy environment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants tested with comparator devices first, then Audeo Lumity devices | Experimental | All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices. |
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| Participants who were tested with Audeo Lumity first, then comparator devices | Experimental | All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phonak Audeo previous generation hearing aids | Device | Receiver-in-canal (RIC) hearing aids with universal earpieces |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech in Noise Test | A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better. | Day 1 of study |
| Subjective Perception of Listening Effort | Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort. | Day 1 of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phonak Audiology Research Center | Aurora | Illinois | 60504 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Tested With Comparator Devices First, Than Audeo Lumity Devices | All participants who completed speech in noise testing in the lab with the comparator devices first, and then the Audeo Lumity devices. Phonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces Phonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces |
| FG001 | Participants Tested With Audeo Lumity First, Than Comparator Devices | All participants who completed speech in noise testing in the lab with the Audeo Lumity devices first, and then the comparator devices. Phonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces Phonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants Tested With Both Devices. | Participants who complete lab testing and home trials with both the comparator devices and the Audeo Lumity devices. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Speech in Noise Test | A speech in noise test in which participants repeat words which are presented in the presence of background noise. In a 12-speaker array, speech is presented from speakers either on the left side of the participant (-90 degrees) or from behind the participant (180 degrees) while background noise is presented from remaining speakers. Scores are calculated as the number of words correctly repeated and expressed as a percentage. A higher percentage or score is better. | Posted | Mean | Full Range | percentage of correct responses | Day 1 of study |
|
4 Weeks. Participants had one day testing in the lab followed by a two week home trial.
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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 | All Participants Who Wore Comparator Devices | All participants who completed lab testing and home trial with the Comparator devices. Phonak Audeo previous generation hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Sonova USCS | 630-821-5000 | phonakaudiologyresearch@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2022 | Jul 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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Participants were blinded as to which device they were wearing during the lab testing.
| Phonak Audeo Lumity hearing aids | Device | Receiver-in-canal (RIC) hearing aids with universal earpieces |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Subjective Perception of Listening Effort | Following the speech in noise testing in the lab, participants rated their listening effort on a scale from 1 to 10, with 1 = no effort and 10 = a lot of effort. In this case, a lower rating is better as it indicates less perceived listening effort. | Posted | Mean | Full Range | score on a scale | Day 1 of study |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | All Participants Who Wore Audeo Lumity Devices | All participants who completed lab testing and home trial with the Audeo Lumity devices. Phonak Audeo Lumity hearing aids: Receiver-in-canal (RIC) hearing aids with universal earpieces | 0 | 14 | 0 | 14 | 0 | 14 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |