Trial Outcomes & Findings for Remote Microphone (RM) - A Comparative Study (NCT NCT04147611)
NCT ID: NCT04147611
Last Updated: 2023-04-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
2 hours
Results posted on
2023-04-26
Participant Flow
Participant milestones
| Measure |
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:
1. Bone Conduction Device (BAHA) only
2. BAHA + Wireless Audio-Streaming Accessory
3. BAHA + Digital Adaptive RM System
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.
|
Normal Hearing Controls
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
1. Unaided
2. Unilateral hearing aid with contralateral plug.
3. Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
4. Bone Conduction Device (BAHA) only
5. BAHA + Wireless Audio-Streaming Accessory
6. BAHA + Digital Adaptive RM System
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.
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|---|---|---|
|
Overall Study
STARTED
|
9
|
13
|
|
Overall Study
COMPLETED
|
9
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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:
1. Bone Conduction Device (BAHA) only
2. BAHA + Wireless Audio-Streaming Accessory
3. BAHA + Digital Adaptive RM System
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.
|
Normal Hearing Controls
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
1. Unaided
2. Unilateral hearing aid with contralateral plug.
3. Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
4. Bone Conduction Device (BAHA) only
5. BAHA + Wireless Audio-Streaming Accessory
6. BAHA + Digital Adaptive RM System
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.
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|---|---|---|
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Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Remote Microphone (RM) Technology Group
n=9 Participants
The RM technology group will limited to the pediatrics participants.
Participants will be tested separately on the three following conditions:
1. Bone Conduction Device (BAHA) only
2. BAHA + Wireless Audio-Streaming Accessory
3. BAHA + Digital Adaptive RM System
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.
|
Normal Hearing Controls
n=13 Participants
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
1. Unaided
2. Unilateral hearing aid with contralateral plug.
3. Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
4. Bone Conduction Device (BAHA) only
5. BAHA + Wireless Audio-Streaming Accessory
6. BAHA + Digital Adaptive RM System
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.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.67 years
STANDARD_DEVIATION 3.54 • n=9 Participants
|
27.83 years
STANDARD_DEVIATION 4.73 • n=13 Participants
|
20.90 years
STANDARD_DEVIATION 9.20 • n=22 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
11 Participants
n=13 Participants
|
15 Participants
n=22 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
2 Participants
n=13 Participants
|
7 Participants
n=22 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Data is provided for all participants who completed the study.
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.
Outcome measures
| Measure |
Remote Microphone (RM) Technology Group
n=9 Participants
The RM technology group will limited to the pediatrics participants.
Participants will be tested separately on the three following conditions:
1. Bone Conduction Device (BAHA) only
2. BAHA + Wireless Audio-Streaming Accessory
3. BAHA + Digital Adaptive RM System
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.
|
Normal Hearing Controls
n=12 Participants
The normal hearing controls will be limited to 15 adults.
Participants will be tested separately on the six following conditions:
1. Unaided
2. Unilateral hearing aid with contralateral plug.
3. Unilateral hearing aid + Digital Adaptive RM System (using Roger™, Sonova)
4. Bone Conduction Device (BAHA) only
5. BAHA + Wireless Audio-Streaming Accessory
6. BAHA + Digital Adaptive RM System
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.
|
|---|---|---|
|
Percentage of Correct Word Responses
Bone Conduction Device (BCD) / Baha BCD only
|
2.21 percentage of correct word responses
Standard Deviation 3.6
|
0.1 percentage of correct word responses
Standard Deviation 0.4
|
|
Percentage of Correct Word Responses
BCD/Baha BCD and Remote Microphone (RM)
|
71.7 percentage of correct word responses
Standard Deviation 24.3
|
87.9 percentage of correct word responses
Standard Deviation 8.7
|
|
Percentage of Correct Word Responses
BCD/Baha BCD, RM, and Digital RM
|
1.5 percentage of correct word responses
Standard Deviation 2.2
|
11.2 percentage of correct word responses
Standard Deviation 13.9
|
Adverse Events
Remote Microphone (RM) Technology Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Hearing Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place