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

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Brief Title

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

Official Title

Study of the Hearing Performance and Comfort of a New Bone Conduction Hearing System - Comparison to the Osteo-integrated Bone Conduction Hearing Aid Mounted on a Headband: Prospective Open Multicenter Randomized Crossover Study

Brief 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.
    

Detailed Description

      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 hearing loss when an acoustic hearing aid can't be used.

      These prostheses are percutaneous but for children the implantation of the osseointegrated
      abutment requires that the child has developed a sufficient bone thickness. In general,
      surgery is not possible before the age of 5 years. [Doshi et al. 2012].

      They can be mounted on headband for testing [Haute Autorité de Santé, HAS 2008] or avoid
      surgery especially for very young children [e.g. Hol et al. 2005, Verhagen et al. 2008, Doshi
      et al. 2012, Doshi and McDermott 2015]. In this case the vibration of the bone is through the
      skin. But these systems on headband pose problems of maintenance and pressure on the skin.

      Standard headband pre-tests are recommended by HAS [HAS 2014] and the bone anchored hearing
      aid is a gold standard for preoperative evaluation in children. It can be used to predict the
      potential benefit of the implanted system [Doshi et al. 2012]. Several transcutaneous systems
      are developed today [Reinfelt 2015, Doshi et al. 2012, Doshi and McDermott 2015] but they
      also require surgery and have an age limit before implantation.

      MED-EL company has developed a new bone conduction system, ADHEAR, that does not require
      surgery and that transmits the sound by bone vibration through the skin. This system has the
      advantage of not applying pressure on the skin and has no age limit.

      Objective of the study:

      The objective of the study is to compare the new ADHEAR bone conduction hearing aid for
      children with conductive hearing loss to the commonly used reference system, the
      osteointegrated bone conduction prosthesis.

      Comparator:

      The comparator is the same in all the centers and will be the PONTO 3 SUPER POWER mounted on
      softband.

      Hypotheses

      The hypotheses are that patients with the ADHEAR bone conduction hearing aid:

        -  do not have a mean tonal gain lower than that obtained with a PONTO 3 SUPERPOWER mounted
           on a softband.

        -  have a gain in comfort compared to a PONTO 3 SUPERPOWER mounted on a sofband

      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.

        -  To evaluate the satisfaction and use of ADHEAR.

      Plan of study

      It is a prospective open multicenter randomized crossover study: measures will be done on the
      patient at the inclusion then by randomisation a first system (ADHEAR or PONTO 3 SUPER POWER
      on softband) will be fit to the patient and he will take it at home for 15 days. Afterwards,
      the patient will come back to the clinical center and measurements will be done with the
      first system. Then the patient will be fitted with the second system (PONTO 3 SUPER POWER on
      softband or ADHEAR) and will take it at home for 15 days. Afterwards, the patient will come
      back to the clinical center and measurements will be done with the second system.
    


Study Type

Interventional


Primary Outcome

Average tonal gain (dB)

Secondary Outcome

 Skin reactions

Condition

Conductive Hearing Loss

Intervention

ADHEAR and PONTO 3 SUPER POWER on softband hearing aids

Study Arms / Comparison Groups

 ADHEAR-PONTO
Description:  The ADHEAR system will be fitted to the patient who will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the ADHEAR system. Then the patient will be fitted with the PONTO 3 SUPER POWER on softband and will take it at home for 15 days. Afterwards, the patient will come back to the clinical center and measurements will be done with the PONTO 3 SUPER POWER on softband.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

0

Start Date

July 15, 2018

Completion Date

July 15, 2019

Primary Completion Date

July 15, 2019

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:
      

Gender

All

Ages

5 Years - 15 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT03541967

Organization ID

MED-EL_ADHEAR_french_study1


Responsible Party

Sponsor

Study Sponsor

MED-EL Elektromedizinische Geräte GesmbH


Study Sponsor

, , 


Verification Date

June 2019