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The present study will investigate the benefit of hearing aids for speech intelligibility (in both quiet and noisy environments) compared to the unaided condition. Participants will include adults with moderate to moderately severe hearing impairment. The participants will complete laboratory-based speech intelligibility assessments with binaural hearing aids and without hearing aids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | All participants will be fit with the study hearing aid and under go the same testing conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New hearing aid | Device | Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility in Quiet. | Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions. | Day 1 and Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words | Speech intelligibility on key words for sentences presented in noise. Noise is presented at a fixed level, and the words are presented at adaptive levels, below and above the noise level. A negative number is better, because it indicates the participant can correctly repeat 50% of the words when the words are below the level of noise. This was done at baseline in the unaided condition on Day 1 of the study, and in the aided condition on Day 15. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Seitz-Paquette, AuD | Sonova AG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phonak Audiology Research Center | Aurora | Illinois | 60504 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | All participants will be fit with the study hearing aid and under go the same testing conditions. New hearing aid: Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | All participants will be fit with the study hearing aid and under go the same testing conditions. New hearing aid: Participants will complete testing while using a novel hearing aid which has been fit to compensate for their hearing loss. |
| 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, 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 Intelligibility in Quiet. | Speech intelligibility for monosyllabic words presented in quiet. The words are presented at a fixed level and the percentage of words correctly repeated is calculated. A higher percentage is better. This was done in both unaided and aided conditions. | It was discovered after data collection that the equipment used in this outcome measure was not functioning properly and the dB level presented was not the dB level that was indicated on the equipment. Therefore, this data was not used and no statistical analysis was done. | Posted | Mean | Full Range | percentage of correct responses | Day 1 and Day 15 |
|
15 days
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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 | Experimental | All participants will be fit with the study hearing aid and under go the same testing conditions. All participants underwent unaided speech in quiet and speech in noise testing on Day 1 of study. Following a 14 day field trial, all participants completed the same tests but in the aided condition. Adverse events were monitored for all participants during this two week period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Sonova US Corporate Services, LLC | 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 | Feb 4, 2022 | Apr 7, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Day 1 and Day 15 |
| 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 | Number | participants |
|
|
|
| Secondary | Speech Intelligibility in Noise, Expressed as the Signal to Noise Ratio at Which Participant Can Correctly Repeat 50% of the Words | Speech intelligibility on key words for sentences presented in noise. Noise is presented at a fixed level, and the words are presented at adaptive levels, below and above the noise level. A negative number is better, because it indicates the participant can correctly repeat 50% of the words when the words are below the level of noise. This was done at baseline in the unaided condition on Day 1 of the study, and in the aided condition on Day 15. | All study participants who were fit with study devices who underwent speech in noise testing in both unaided and aided conditions. | Posted | Mean | Standard Deviation | dB Signal-to-Noise Ratio | Day 1 and Day 15 |
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| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |