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| Name | Class |
|---|---|
| Cochlear | INDUSTRY |
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The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology. In this study, two remote microphone technologies will be evaluated to determine benefit in speech understanding in noise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remote Microphone (RM) Technology Group | Experimental | The RM technology group will limited to the pediatrics participants. Participants will be tested separately on the three following conditions:
|
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| Normal Hearing Controls | Active Comparator | The normal hearing controls will be limited to 15 adults. Participants will be tested separately on the six following conditions:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAHA | Device | Participant's pediatric bone conduction hearing device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Correct Word Responses | Percentage of correct word responses as assessed via the Pediatric AZBio Sentence List test at -10 decibels (dB) signal to noise ratio. The total score ranges from 0-100% with the higher score indicating increased listening in noise performance. | 2 hours |
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Pediatric RM Technology Group:
Inclusion Criteria:
Exclusion Criteria:
- Participants who do not meet the described inclusion criteria.
Normal Hearing Controls:
Inclusion Criteria:
Exclusion Criteria:
- Non-English speakers.
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| Name | Affiliation | Role |
|---|---|---|
| Hillary Snapp, AuD, Ph.D. | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kristine Harris | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Remote Microphone (RM) Technology Group | The RM technology group will limited to the pediatrics participants. Participants will be tested separately on the three following conditions:
BAHA: Participant's pediatric bone conduction hearing device. Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. |
| FG001 | Normal Hearing Controls | The normal hearing controls will be limited to 15 adults. Participants will be tested separately on the six following conditions:
BAHA: Participant's pediatric bone conduction hearing device. Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. Hearing Aid: Participant's unilateral hearing aid with contralateral plug. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Remote Microphone (RM) Technology Group | The RM technology group will limited to the pediatrics participants. Participants will be tested separately on the three following conditions:
BAHA: Participant's pediatric bone conduction hearing device. Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. |
| 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 | Percentage of Correct Word Responses | Percentage of correct word responses as assessed via the Pediatric AZBio Sentence List test at -10 decibels (dB) signal to noise ratio. The total score ranges from 0-100% with the higher score indicating increased listening in noise performance. | Data is provided for all participants who completed the study. | Posted | Mean | Standard Deviation | percentage of correct word responses | 2 hours |
|
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Remote Microphone (RM) Technology Group | The RM technology group will limited to the pediatrics participants. Participants will be tested separately on the three following conditions:
BAHA: Participant's pediatric bone conduction hearing device. Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hillary Snapp | University of Miami | 305-243-4611 | hsnapp@med.miami.edu |
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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 | Jun 11, 2021 | Jun 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006314 | Hearing Loss, Conductive |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D006310 | Hearing Aids |
| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
| D012682 | Sensory Aids |
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| Wireless Audio Streaming Accessory | Device | Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. |
|
| Digital Adaptive RM System | Device | Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. |
|
| Hearing Aid | Device | Participant's unilateral hearing aid with contralateral plug. |
|
| BG001 | Normal Hearing Controls | The normal hearing controls will be limited to 15 adults. Participants will be tested separately on the six following conditions:
BAHA: Participant's pediatric bone conduction hearing device. Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. Hearing Aid: Participant's unilateral hearing aid with contralateral plug. |
| 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 |
|
| OG001 | Normal Hearing Controls | The normal hearing controls will be limited to 15 adults. Participants will be tested separately on the six following conditions:
BAHA: Participant's pediatric bone conduction hearing device. Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. Hearing Aid: Participant's unilateral hearing aid with contralateral plug. |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Normal Hearing Controls | The normal hearing controls will be limited to 15 adults. Participants will be tested separately on the six following conditions:
BAHA: Participant's pediatric bone conduction hearing device. Wireless Audio Streaming Accessory: Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device. Digital Adaptive RM System: Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid. Hearing Aid: Participant's unilateral hearing aid with contralateral plug. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |