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Search / Trial NCT03541967

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

Launched by MED-EL ELEKTROMEDIZINISCHE GERÄTE GESMBH · May 30, 2018

Trial Information

Current as of June 12, 2025

Withdrawn

Keywords

Bone Conduction

ClinConnect Summary

Introduction

Hearing loss, or deafness, is defined by the decrease in the perception of sounds. Conductive hearing loss is characterized by damage to the outer or middle ear. Its etiologies are congenital, malformative or acquired, sequelae of infectious or inflammatory processes (chronic otitis).

They cause a defect in the transmission of the sound towards the cochlea. Conductive hearing loss can be compensated by bone conduction hearing aids or middle ear implants.

Osteo-integrated bone conduction hearing aids (Baha, Ponto) have become the standard of care for patients with conductive ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age: between 5 and 15 years old.
  • Child for whom a bone conduction prosthesis test is indicated
  • conductive hearing loss: bone conduction ≤ 10 dB Hearing Level (HL)
  • Contralateral ear: air conduction ≤ 30 dB HL at 500, 1000, 2000, 3000 and 4000Hz
  • No test of conductive bone conduction hearing aid with softband in the 3 months preceding the study
  • No associated disorders
  • Child not already fitted with a bone conduction system
  • Exclusion Criteria:

About Med El Elektromedizinische Geräte Gesmbh

MED-EL Elektromedizinische Geräte GmbH is a leading innovator in the field of medical technology, specializing in advanced hearing solutions. Established in 1989, the company focuses on developing implantable hearing devices and comprehensive rehabilitation solutions aimed at improving the quality of life for individuals with hearing loss. With a commitment to research and development, MED-EL collaborates with healthcare professionals and academic institutions to drive clinical trials that enhance auditory care and foster groundbreaking advancements in hearing healthcare. Their dedication to innovation and excellence positions MED-EL as a pivotal player in the global medical device industry.

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Timeline

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Trial launched

Trial updated

Estimated completion

Not reported

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