Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
22 participants
INTERVENTIONAL
2019-10-21
2020-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Use of RM Technology in Pediatric BAI Recipients
NCT03149484
Remote Care: The Future of Cochlear Implants
NCT04721327
A Pediatric Comparison of Remote Microphone Technologies
NCT06564701
Investigation of a Device to Deliver Intra-Operative Therapeutic Hypothermia for Hearing Preservation in Cochlear Implantation
NCT06375278
Team-based Virtual Pediatric Cochlear Implant Clinic
NCT05030961
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Normal Hearing Controls:
* Adults greater than18 years of age.
* Hearing thresholds \< 25 dB 500 - 4,000 Hz.
Exclusion Criteria
5 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cochlear
INDUSTRY
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hillary A Snapp
Associate Professor of Clinical
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hillary Snapp, AuD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kristine Harris
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20190308
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.