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Bone Conduction Implant
Bone Conduction Implant for Hearing Loss
N/A
Recruiting
Research Sponsored by Med-El Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Under 12 years of age
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to six (6) months post-activation
Awards & highlights
Study Summary
This trial tests a medical implant that helps kids with hearing loss by using vibrations to send sounds to their inner ear.
Who is the study for?
This trial is for children under 12 with conductive or mixed hearing loss who can provide a speech recognition threshold, have tried hearing aids (unless unable to for medical reasons), and have enough bone quality for implantation. Kids under 3, those with conditions that make surgery risky, prior ear implants, skin conditions affecting processor use, balance disorders, worsening hearing loss or retrocochlear issues cannot join.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of the MED-EL BONEBRIDGE Bone Conduction Implant in young kids. It aims to see how well this implant helps children who struggle with certain types of hearing loss hear better.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort at the implant site, skin irritation around the processor area, possible infection risk post-surgery and interference with sound quality or volume perception.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am younger than 12 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to six (6) months post-activation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to six (6) months post-activation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Functional gain
Secondary outcome measures
Post-intervention quality-of-life questionnaire
Bone and Bones
Word recognition score
Trial Design
1Treatment groups
Experimental Treatment
Group I: Study procedureExperimental Treatment1 Intervention
This single-arm, repeated-measures study includes study visits at baseline, surgery, device activation, and at 1, 3, 6, and 12 months post-activation.
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Who is running the clinical trial?
Med-El CorporationLead Sponsor
23 Previous Clinical Trials
977 Total Patients Enrolled
1 Trials studying Mixed Hearing Loss
8 Patients Enrolled for Mixed Hearing Loss
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There is a large enough gap between the air and bone in the ear for the implant to be inserted.Your hearing in the ear that will be operated on is better than or equal to 45 decibels at certain frequencies without any help from hearing devices.I am younger than 12 years old.You currently have a hearing implant in one ear.Evidence that hearing loss comes from behind the inner ear.I cannot use an external audio processor due to a skin or scalp condition.You need to have the ability to understand and respond to spoken English without any help.My child is under 3 years old.A special scan shows that your ear has enough strong bone for the implant to be put in.I have a health issue that makes surgery or anesthesia risky for me.I have long-term issues with balance or dizziness that can't be corrected.My hearing is getting worse quickly.
Research Study Groups:
This trial has the following groups:- Group 1: Study procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are executing this experiment?
"This study is taking place in multiple sites including University of Utah Health/Primary Children's Hospital in Salt Lake City, the University of Miami located in Florida, and the University Carolina at Chapel Hill. There will be 6 other medical centres involved as well."
Answered by AI
Is this research open to those aged 80 and younger?
"The age limit for inclusion in this study is 3 years old to 12 years old."
Answered by AI
Are there any opportunities to join this research endeavor at present?
"According to clinicaltrials.gov, the enrollment for this medical trial has been suspended as of November 7th 2022. When first posted on December 1st 2022, it was looking for participants; however, there are currently 164 other trials that are actively searching for recruits."
Answered by AI
May I be considered for inclusion in this experiment?
"The requirements for entrance into this study are mixed hearing loss and an age of 3-12 years; a maximum of 36 individuals may be accepted."
Answered by AI
Who else is applying?
What site did they apply to?
University of North Carolina
What portion of applicants met pre-screening criteria?
Did not meet criteria
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