NCT03541967

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2019

Completed
Last Updated

June 20, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

May 4, 2018

Last Update Submit

June 19, 2019

Conditions

Conductive Hearing Loss

Keywords

bone conduction

Outcome Measures

Primary Outcomes (2)

  • 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.

    15 days after fitting of the system and port at home

  • 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

    15 days after fitting of the system and port at home

Secondary Outcomes (7)

  • Skin reactions

    15 days after fitting of the system and port at home

  • Bone conduction thresholds (dB Hearing Level (HL))

    at the inclusion and 30 days after

  • Subjective measurement of auditory perception

    15 days after fitting of the system and port at home

  • Measurement of satisfaction and use of ADHEAR

    15 days after fitting of the system and port at home

  • Air conduction threshold (dB HL)

    at the inclusion and 30 days after

  • +2 more secondary outcomes

Study Arms (2)

ADHEAR-PONTO

OTHER

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.

Device: ADHEAR and PONTO 3 SUPER POWER on softband hearing aids

PONTO-ADHEAR

OTHER

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.

Device: ADHEAR and PONTO 3 SUPER POWER on softband hearing aids

Interventions

ADHEAR and PONTO 3 SUPER POWER on softband hearing aidsDEVICE

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

ADHEAR-PONTOPONTO-ADHEAR

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2018

First Posted

May 31, 2018

Study Start

July 15, 2018

Primary Completion

July 15, 2019

Study Completion

July 15, 2019

Last Updated

June 20, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share