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Comparison of a New Bone Conduction Hearing System to a Osteo-integrated Bone Conduction Hearing Aid on a Softband

NCT03541967 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-06-20

No results posted yet for this study

Summary

Main objectives

* The first main objective is to evaluate the non-inferiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of average tonal gain.
* The second main objective of the study is to evaluate the superiority of the ADHEAR system compared to the PONTO 3 SUPERPOWER softband system in terms of comfort.

Secondary objectives

* Evaluate skin reactions with ADHEAR and PONTO 3 SUPER POWER on softband.
* Evaluate and compare perception in silence and noise with ADHEAR and PONTO 3 SUPER POWER on softband.
* Evaluate and compare the subjective auditory perception with ADHEAR and PONTO 3 SUPER POWER on softband.
* Evaluate the satisfaction and use of ADHEAR.

Conditions

  • Conductive Hearing Loss

Interventions

DEVICE

ADHEAR and PONTO 3 SUPER POWER on softband hearing aids

Device: ADHEAR non-implantable bone conduction hearing aid Comparator: PONTO 3 SUPER POWER bone conduction hearing aid with softband

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-15
Primary Completion
2019-07-15
Completion
2019-07-15
FDA Device
Yes

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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 NCT03541967 on ClinicalTrials.gov