Hearing Loss, Conductive
Conditions
Brief summary
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.
Interventions
DEVICEBAHA
Participant's pediatric bone conduction hearing device.
DEVICEWireless 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.
DEVICEDigital 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.
DEVICEHearing Aid
Participant's unilateral hearing aid with contralateral plug.
Sponsors
Cochlear
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Pediatric RM Technology Group: Inclusion Criteria: * English speaking pediatric conduction device users and their guardian/s will be included for study. * We will include pediatric patients 5 years of age to 17 years of age who have a conductive or mixed unilateral or bilateral hearing loss with a minimum of a 30 decibels (dB) air-bone gap.
Exclusion criteria
\- Participants who do not meet the described inclusion criteria. Normal Hearing Controls: Inclusion Criteria: * Adults greater than18 years of age. * Hearing thresholds \< 25 dB 500 - 4,000 Hz.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Correct Word Responses | 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 13 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Remote Microphone (RM) Technology Group | Normal Hearing Controls | Total |
|---|---|---|---|
| Age, Continuous | 11.67 years STANDARD_DEVIATION 3.54 | 27.83 years STANDARD_DEVIATION 4.73 | 20.90 years STANDARD_DEVIATION 9.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 15 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 2 hours
Population: Data is provided for all participants who completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remote Microphone (RM) Technology Group | Percentage of Correct Word Responses | Bone Conduction Device (BCD) / Baha BCD only | 2.21 percentage of correct word responses | Standard Deviation 3.6 |
| Remote Microphone (RM) Technology Group | Percentage of Correct Word Responses | BCD/Baha BCD and Remote Microphone (RM) | 71.7 percentage of correct word responses | Standard Deviation 24.3 |
| Remote Microphone (RM) Technology Group | Percentage of Correct Word Responses | BCD/Baha BCD, RM, and Digital RM | 1.5 percentage of correct word responses | Standard Deviation 2.2 |
| Normal Hearing Controls | Percentage of Correct Word Responses | Bone Conduction Device (BCD) / Baha BCD only | 0.1 percentage of correct word responses | Standard Deviation 0.4 |
| Normal Hearing Controls | Percentage of Correct Word Responses | BCD/Baha BCD and Remote Microphone (RM) | 87.9 percentage of correct word responses | Standard Deviation 8.7 |
| Normal Hearing Controls | Percentage of Correct Word Responses | BCD/Baha BCD, RM, and Digital RM | 11.2 percentage of correct word responses | Standard Deviation 13.9 |