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

Primary Purpose

Conductive Hearing Loss

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ADHEAR and PONTO 3 SUPER POWER on softband hearing aids
Sponsored by
MED-EL Elektromedizinische Geräte GesmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Conductive Hearing Loss focused on measuring bone conduction

Eligibility Criteria

5 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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:

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    ADHEAR-PONTO

    PONTO-ADHEAR

    Arm 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.

    The PONTO 3 SUPER POWER on softband 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 PONTO 3 SUPER POWER on softband. Then the patient will be fitted with the ADHEAR system 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 ADHEAR system.

    Outcomes

    Primary Outcome Measures

    Average tonal gain (dB)
    The threshold of free-field tonal audiometry is measured in the free field with masking of the contralateral ear with and without the auditory system. The tonal gain is defined by the difference of the tonal threshold with / without the auditory system. The average tonal gain is defined by the average of the tonal gain at frequencies 500, 1000, 2000, 3000 and 4000 Hz.
    Comfort
    Perceived comfort will be measured with a visual analogue scale (VAS) of 10 cm overall comfort. The VAS will have the following anchors: 10 = very comfortable; 8 = comfortable; 6 = comfortable enough; 4 = uncomfortable; 2 = very uncomfortable; 0 = not comfortable at all

    Secondary Outcome Measures

    Skin reactions
    The measurement of cutaneous reactions with the auditory system will be done with a Holgers scale by the practitioner. Holgers scale: 0 = No irritation; 1 = Slight redness; 2 = Red and slightly moist tissue; 3= Reddish and moist; 4 = Removal of hearing aid system necessary R = Removal of hearing aid system for reasons not related to skin problems
    Bone conduction thresholds (dB Hearing Level (HL))
    The air conduction threshold conduction is measured with a headphone at 250, 500, 1000, 2000, 3000 and 4000 Hz. The variation is defined by the difference of bone conduction threshold at each frequency at the inclusion and at the end of the inclusion.
    Subjective measurement of auditory perception
    The subjective auditory perception will be measured by a self-questionnaire to be completed by the parents: the Speech, Spatial, and Qualities of Hearing Scale (SSQ) for Parents [Galvin and Noble 2013]. The parents have to answer questions about specific situations for their child with and without the hearing system. SSQ items have VAS from 0 to 10 with integer anchors and qualitative anchors "not at all" for 0 and "perfectly" for 10. Scores are calculated for three subscales: on speech perception: 9 VAS on spatial localization: 6 VAS on the quality of hearing: 8 VAS On each subscale the difference of score with and without the hearing system is calculated.
    Measurement of satisfaction and use of ADHEAR
    The satisfaction and use of ADHEAR will be measured by a specific MED-EL self-questionnaire. Twenty questions with various qualitative answers. The analysis is descriptive for each question.
    Air conduction threshold (dB HL)
    The air conduction threshold conduction is measured with a headphone at 250, 500, 1000, 2000, 3000, 4000 and 8000 Hz. The variation is defined by the difference of air conduction threshold at each frequency at the inclusion and at the end of the inclusion.
    Vocal audiometry in silence
    Measure of the speech reception threshold (i.e. the speech intensity in dB Sound Pressure Level (SPL)) for 50% (SRT50) and 100% (SRT100) of comprehension of words (list of Boorsma) in free field (with masking of the contralateral ear) with and without the auditory system. The gain (dB) is defined by the difference of SRT with/without the auditory system.
    Vocal audiometry in noise
    Hirsch test in dichotic condition: signal = speech words (list of Boorsma) on the side of the auditory system ; noise = white noise at 65 dB Sound Pressure Level (SPL) in front of the patient (0°). Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) and 100% (SRT100) of comprehension of words (list of Boorsma) in free field with and without the auditory system. The gain (dB) is defined by the difference of SRT with/without the auditory system.

    Full Information

    First Posted
    May 4, 2018
    Last Updated
    June 19, 2019
    Sponsor
    MED-EL Elektromedizinische Geräte GesmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03541967
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    overload costs
    Study Start Date
    July 15, 2018 (Anticipated)
    Primary Completion Date
    July 15, 2019 (Anticipated)
    Study Completion Date
    July 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    MED-EL Elektromedizinische Geräte GesmbH

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Conductive Hearing Loss
    Keywords
    bone conduction

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ADHEAR-PONTO
    Arm Type
    Other
    Arm 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.
    Arm Title
    PONTO-ADHEAR
    Arm Type
    Other
    Arm Description
    The PONTO 3 SUPER POWER on softband 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 PONTO 3 SUPER POWER on softband. Then the patient will be fitted with the ADHEAR system 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 ADHEAR system.
    Intervention Type
    Device
    Intervention Name(s)
    ADHEAR and PONTO 3 SUPER POWER on softband hearing aids
    Intervention Description
    Device: ADHEAR non-implantable bone conduction hearing aid Comparator: PONTO 3 SUPER POWER bone conduction hearing aid with softband
    Primary Outcome Measure Information:
    Title
    Average tonal gain (dB)
    Description
    The threshold of free-field tonal audiometry is measured in the free field with masking of the contralateral ear with and without the auditory system. The tonal gain is defined by the difference of the tonal threshold with / without the auditory system. The average tonal gain is defined by the average of the tonal gain at frequencies 500, 1000, 2000, 3000 and 4000 Hz.
    Time Frame
    15 days after fitting of the system and port at home
    Title
    Comfort
    Description
    Perceived comfort will be measured with a visual analogue scale (VAS) of 10 cm overall comfort. The VAS will have the following anchors: 10 = very comfortable; 8 = comfortable; 6 = comfortable enough; 4 = uncomfortable; 2 = very uncomfortable; 0 = not comfortable at all
    Time Frame
    15 days after fitting of the system and port at home
    Secondary Outcome Measure Information:
    Title
    Skin reactions
    Description
    The measurement of cutaneous reactions with the auditory system will be done with a Holgers scale by the practitioner. Holgers scale: 0 = No irritation; 1 = Slight redness; 2 = Red and slightly moist tissue; 3= Reddish and moist; 4 = Removal of hearing aid system necessary R = Removal of hearing aid system for reasons not related to skin problems
    Time Frame
    15 days after fitting of the system and port at home
    Title
    Bone conduction thresholds (dB Hearing Level (HL))
    Description
    The air conduction threshold conduction is measured with a headphone at 250, 500, 1000, 2000, 3000 and 4000 Hz. The variation is defined by the difference of bone conduction threshold at each frequency at the inclusion and at the end of the inclusion.
    Time Frame
    at the inclusion and 30 days after
    Title
    Subjective measurement of auditory perception
    Description
    The subjective auditory perception will be measured by a self-questionnaire to be completed by the parents: the Speech, Spatial, and Qualities of Hearing Scale (SSQ) for Parents [Galvin and Noble 2013]. The parents have to answer questions about specific situations for their child with and without the hearing system. SSQ items have VAS from 0 to 10 with integer anchors and qualitative anchors "not at all" for 0 and "perfectly" for 10. Scores are calculated for three subscales: on speech perception: 9 VAS on spatial localization: 6 VAS on the quality of hearing: 8 VAS On each subscale the difference of score with and without the hearing system is calculated.
    Time Frame
    15 days after fitting of the system and port at home
    Title
    Measurement of satisfaction and use of ADHEAR
    Description
    The satisfaction and use of ADHEAR will be measured by a specific MED-EL self-questionnaire. Twenty questions with various qualitative answers. The analysis is descriptive for each question.
    Time Frame
    15 days after fitting of the system and port at home
    Title
    Air conduction threshold (dB HL)
    Description
    The air conduction threshold conduction is measured with a headphone at 250, 500, 1000, 2000, 3000, 4000 and 8000 Hz. The variation is defined by the difference of air conduction threshold at each frequency at the inclusion and at the end of the inclusion.
    Time Frame
    at the inclusion and 30 days after
    Title
    Vocal audiometry in silence
    Description
    Measure of the speech reception threshold (i.e. the speech intensity in dB Sound Pressure Level (SPL)) for 50% (SRT50) and 100% (SRT100) of comprehension of words (list of Boorsma) in free field (with masking of the contralateral ear) with and without the auditory system. The gain (dB) is defined by the difference of SRT with/without the auditory system.
    Time Frame
    15 days after fitting of the system and port at home
    Title
    Vocal audiometry in noise
    Description
    Hirsch test in dichotic condition: signal = speech words (list of Boorsma) on the side of the auditory system ; noise = white noise at 65 dB Sound Pressure Level (SPL) in front of the patient (0°). Measure of the speech reception threshold (i.e. the speech intensity in dB SPL) for 50% (SRT50) and 100% (SRT100) of comprehension of words (list of Boorsma) in free field with and without the auditory system. The gain (dB) is defined by the difference of SRT with/without the auditory system.
    Time Frame
    15 days after fitting of the system and port at home

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    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:

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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