Bone anchored hearing aid (BAHA) for Conductive Hearing Loss

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami Department of Otolaryngology, Miami, FLConductive Hearing Loss+1 MoreBone anchored hearing aid (BAHA) - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary

This trial is testing two types of hearing devices to see which works better.

Eligible Conditions
  • Conductive Hearing Loss
  • Unilateral Hearing Loss

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Up to 14 weeks

Up to 14 weeks
Aided hearing thresholds
Speech
Subjective report

Trial Safety

Trial Design

6 Treatment Groups

Single-Sided Deafness Adult (Aim1) Group
1 of 6
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group
1 of 6
Adhear followed by BAHA (Aim 3) Group
1 of 6
BAHA followed by Adhear (Aim 3) Group
1 of 6
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group
1 of 6
Conductive Hearing Loss Adult (Aim 2) Group
1 of 6

Experimental Treatment

66 Total Participants · 6 Treatment Groups

Primary Treatment: Bone anchored hearing aid (BAHA) · No Placebo Group · N/A

Single-Sided Deafness Adult (Aim1) Group
Device
Experimental Group · 1 Intervention: Adhear Bone Conduction System · Intervention Types: Device
Pediatric Unilateral Conductive Hearing Loss (Aim 3a) Group
Device
Experimental Group · 1 Intervention: Adhear Bone Conduction System · Intervention Types: Device
Adhear followed by BAHA (Aim 3) GroupExperimental Group · 2 Interventions: Adhear Bone Conduction System, Bone anchored hearing aid (BAHA) · Intervention Types: Device, Device
BAHA followed by Adhear (Aim 3) GroupExperimental Group · 2 Interventions: Adhear Bone Conduction System, Bone anchored hearing aid (BAHA) · Intervention Types: Device, Device
Pediatric Bilateral Conductive Hearing Loss (Aim 3b) Group
Device
Experimental Group · 1 Intervention: Adhear Bone Conduction System · Intervention Types: Device
Conductive Hearing Loss Adult (Aim 2) Group
Device
Experimental Group · 1 Intervention: Adhear Bone Conduction System · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adhear Bone Conduction System
2018
N/A
~70
Bone anchored hearing aid (BAHA)
2018
N/A
~70

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 weeks

Who is running the clinical trial?

Med-El CorporationIndustry Sponsor
19 Previous Clinical Trials
630 Total Patients Enrolled
University of MiamiLead Sponsor
804 Previous Clinical Trials
387,008 Total Patients Enrolled
Hillary Snapp, PhDPrincipal InvestigatorUniversity of Miami

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

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Frequently Asked Questions

Are participants being accepted into this medical trial at present?

"Affirmative. The clinical trial's presence on clinicaltrials.gov demonstrates that this experiment is presently in need of participants; first posted on April 26th 2018 and last modified on August 29 2022, the study requires 90 individuals from a single site." - Anonymous Online Contributor

Unverified Answer

What is the limit to the number of individuals participating in this trial?

"Affirmative. The listing on clinicaltrials.gov reveals that this medical experiment is actively enrolling members, which was first put up for public notice on April 26th 2018 and updated most recently on the 29th of August 2022. A total of 90 individuals are needed to participate at one site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.