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Study participants will be fit with previously released receiver-in-canal (RIC) hearing instruments. Participants will be asked to wear the instruments in their daily life for a minimum of 3 months, but have the option to continue to wear devices for six months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Receiver in the canal hearing instrument 3 month | Experimental | Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months. |
|
| Receiver in the canal hearing instrument 6 month | Experimental | Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Receiver-in-canal hearing instrument | Device | Receiver-in-canal hearing instrument |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Satisfaction of Hearing Aid Performance in Noisy Environments | Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Three months after initial appointment |
| Subjective Satisfaction of Hearing Aid Performance in Noisy Environments | Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Six months after initial appointment |
| Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media | Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Three months after initial appointment |
| Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media | Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Six months after initial appointment |
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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 | Receiver in the Canal Hearing Instrument 3 Month | Group of subjects who will get the receiver in the canal hearing instrument and wear for three months. |
| FG001 | Receiver in the Canal Hearing Instrument 6 Month | Group of participants who will get the receiver in the canal hearing instrument and wear for six months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Receiver in the Canal Hearing Instrument 3 Month | Group of subjects who will get the receiver in the canal hearing instrument for a 3 month period. |
| BG001 | Receiver in the Canal Hearing Instrument 6 Month |
| 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 | Subjective Satisfaction of Hearing Aid Performance in Noisy Environments | Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Participants who answered the question "How satisfied are you with the performance of the hearing aids in noisy environments?" after 3 months of wearing devices. | Posted | Mean | Full Range | score on a scale | Three months after initial appointment |
|
Three months for participants who were in the group assigned devices for three months, and six months for the participants who were in group assigned devices for six months.
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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 | Receiver in the Canal Hearing Instrument 3 Month | Group of subjects who will get the receiver in the canal hearing instrument and wear for period of three months. Receiver-in-canal hearing instrument: Receiver-in-canal hearing instrument |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unanticipated death | Renal and urinary disorders | Non-systematic Assessment | Participant was diagnosed with bladder cancer during the course of the study and passed away from bladder cancer. This was unrelated to study procedure or study devices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Research | Sonova US Corporate Services, LLC | 630-821-5000 | phonakaudiologyresearch@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2023 | Mar 30, 2023 | Prot_001.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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Group of subjects who will get the receiver in the canal hearing instrument for a 6 month period.
| BG002 | Total | Total of all reporting groups |
| 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 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Subjective Satisfaction of Hearing Aid Performance in Noisy Environments | Subject rates how satisfied they are with performance of hearing aid while listening in noisy environments. Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Participants who wore device for six months and answered the question "How satisfied are you with the performance of the hearing aids in noisy environments?" at the end of the six months. | Posted | Mean | Full Range | score on a scale | Six months after initial appointment |
|
|
|
| Primary | Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media | Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Participants who wore devices for three months and who answered the question at the end of the 3 months "How satisfied were you with the performance of the hearing aid when streaming?" | Posted | Mean | Full Range | score on a scale | Three months after initial appointment |
|
|
|
| Primary | Subjective Satisfaction of Hearing Aid Performance While Listening to Streamed Media | Subject rates how satisfied they are with performance of hearing aid when listening to a streamed signal (i.e. music, video, etc.) Ratings range from 1 (very dissatisfied) to 5 (very satisfied) with 3 = Neither satisfied or dissatisfied. | Participants who wore devices for 6 months and who answered the question at the end of the 6 months "How satisfied were you with the performance of the hearing aid when streaming?" | Posted | Mean | Full Range | score on a scale | Six months after initial appointment |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | Receiver in the Canal Hearing Instrument 6 Month | Group of subjects who will get the receiver in the canal hearing instrument and wear for period of six months. Receiver-in-canal hearing instrument: Receiver-in-canal hearing instrument | 1 | 17 | 1 | 17 | 0 | 17 |
|
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |