Hearing Loss, ConductiveNCT04147611
Remote Microphone (RM) - A Comparative Study
A study testing BAHA, Wireless Audio Streaming Accessory and Digital Adaptive RM System in people with Hearing Loss, Conductive, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Hearing Loss, Conductive
- What is being tested?
- BAHA, Wireless Audio Streaming Accessory and Digital Adaptive RM System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- Adults greater than18 years of age.
- Hearing thresholds < 25 dB 500 - 4,000 Hz.
Who cannot join
- Participants who do not meet the described inclusion criteria.
- Normal Hearing Controls:
- Non-English speakers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study
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.
- Conditions
- Hearing Loss, Conductive
- Being tested
- BAHA, Wireless Audio Streaming Accessory, Digital Adaptive RM System, Hearing Aid
- Medical subject headings
- Hearing Loss, Conductive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAHADevice
Participant's pediatric bone conduction hearing device.
Wireless Audio Streaming AccessoryDevice
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 SystemDevice
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 AidDevice
Participant's unilateral hearing aid with contralateral plug.
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. Bone Conduction Device (BAHA) only
2. BAHA + Wireless Audio-Streaming Accessory
3. BAHA + Digital Adaptive RM System Receives: Device: BAHA; Device: Wireless Audio Streaming Accessory; Device: Digital Adaptive RM System |
| 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:
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 Receives: Device: BAHA; Device: Wireless Audio Streaming Accessory; Device: Digital Adaptive RM System; Device: Hearing Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start21 Oct 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, ConductiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Cochlear
- Responsible party
- Principal investigator, Hillary A Snapp, University of Miami
- Investigators
- Hillary Snapp, AuD, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147611
- Sponsor's protocol ID
- 20190308
- Status last verified
- Apr 2023
- First submitted
- 30 Oct 2019
- Last updated
- 26 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study
- ClinicalTrials.gov ID
- NCT04147611
- Acronym / sponsor ID
- 20190308
- Conditions
- Hearing Loss, Conductive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Cochlear
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Posted 23 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote Microphone (RM) Technology Group | Experimental | Device: BAHA, Device: Wireless Audio Streaming Accessory, Device: Digital Adaptive RM SystemThe 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 |
| Normal Hearing Controls | Active comparator | Device: BAHA, Device: Wireless Audio Streaming Accessory, Device: Digital Adaptive RM System, Device: Hearing AidThe 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 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- Adults greater than18 years of age.
- Hearing thresholds < 25 dB 500 - 4,000 Hz.
Key exclusion criteria (3 listed)
- Participants who do not meet the described inclusion criteria.
- Non-English speakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAHAParticipant's pediatric bone conduction hearing device. | Device | Normal Hearing Controls, Remote Microphone (RM) Technology Group |
| Wireless Audio Streaming AccessoryCochlear 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. | Device | Normal Hearing Controls, Remote Microphone (RM) Technology Group |
| Digital Adaptive RM SystemSonova'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. | Device | Normal Hearing Controls, Remote Microphone (RM) Technology Group |
| Hearing AidParticipant's unilateral hearing aid with contralateral plug. | Device | Normal Hearing Controls |
Primary outcome
Percentage of Correct Word Responses
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hillary Snapp, AuD, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAHA, Wireless Audio Streaming Accessory and Digital Adaptive RM System in people with Hearing Loss, Conductive, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Correct Word Responses (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.