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Bone Conduction Device

Bone anchored hearing aid (BAHA) for Conductive Hearing Loss

N/A

Waitlist Available

Led By Hillary Snapp, PhD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28

Awards & highlights

Study Summary

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

Eligible Conditions

Conductive Hearing Loss
Unilateral Hearing Loss

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Aided Hearing Thresholds

Aided Hearing Thresholds for Conductive Hearing Loss

Aided Hearing Thresholds for Single Sided Deafness

Secondary outcome measures

Aided Speech in Noise Performance in Participants With Conductive Hearing Loss

Aided Speech in Noise Performance in Participants With Single-sided Deafness

Aided Speech-in-noise Performance in Participants With Single-sided Deafness

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Single-Sided Deafness Adult (Aim1) GroupExperimental Treatment1 Intervention

Adult participants with single-sided deafness and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).

Group II: Pediatric Unilateral Conductive Hearing Loss (Aim 3a) GroupExperimental Treatment1 Intervention

Pediatric participants (aged 2-17 years) and their parents with unilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system for 2 weeks (plus up to 90 days).

Group III: Pediatric Bilateral Conductive Hearing Loss (Aim 3b) GroupExperimental Treatment1 Intervention

Pediatric participants (aged 2-17 years) and their parents with bilateral conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use) on a headband will be provided with the Adhear system. Participants who are fitted bilaterally will receive 2 Adhear systems (one for each ear) for 2 weeks (plus up to 90 days) at Visit 1. Participants who are fitted unilaterally will receive 1 Adhear system for 2 weeks (plus up to 90 days) at Visit 1, afterwards, will be fitted bilaterally at Visit 2 and receive the Adhear system for both ears for another 2 weeks (plus up to 90 days) for a total of 4 weeks (plus up to 180 days).

Group IV: Conductive Hearing Loss Adult (Aim 2) GroupExperimental Treatment1 Intervention

Adult participants with conductive hearing loss and are experienced bone conduction device users (6 months minimum of bone conduction device use and no intermittent use within the last 2 weeks) with an abutment implant will be provided with the Adhear system for 2 weeks (plus up to 90 days).

Group V: BAHA followed by Adhear (Aim 3) GroupExperimental Treatment2 Interventions

Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the BAHA system for 3 weeks (plus up to 90 days) followed by Adhear for another 3 weeks (plus up to 90 days).

Group VI: Adhear followed by BAHA (Aim 3) GroupExperimental Treatment2 Interventions

Pediatric participants (aged 5-17 years) and their parents with conductive hearing loss or single-sided deafness who have not previously used a bone conduction device, will be provided with the Adhear system for 3 weeks (plus up to 90 days) followed by bone anchored hearing aid (BAHA) for another 3 weeks (plus up to 90 days).

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Med-El CorporationIndustry Sponsor

23 Previous Clinical Trials

947 Total Patients Enrolled

University of MiamiLead Sponsor

899 Previous Clinical Trials

409,666 Total Patients Enrolled

Hillary Snapp, PhDPrincipal InvestigatorUniversity of Miami

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adhear Bone Conduction System

Hillary A Snapp 2018. "Adhear Bone Conduction System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03533686.