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Adhear Bone Conduction System

NCT03533686 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2023-08-08

Study results available
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Summary

The purpose of this research study is to learn about the hearing outcomes of adult and pediatric patients who are treated with or are candidates for bone conductive devices (also termed "BAHA"). Hearing outcomes will also be assessed with a second audio processor device called the Adhear System.

Conditions

  • Hearing Loss, Conductive
  • Hearing Loss, Unilateral

Interventions

DEVICE

Adhear Bone Conduction System

Non-invasive bone conduction hearing device using adhesive

DEVICE

Bone anchored hearing aid (BAHA)

Non-invasive bone conduction hearing device using a headband

Sponsors & Collaborators

  • Med-El Corporation

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Hillary Snapp, PhD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-26
Primary Completion
2022-03-18
Completion
2022-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533686 on ClinicalTrials.gov