REFIT Hearing: Remote Fitting of Hearing Aids (REFITHEARING)

May 18, 2018 updated by: University Hospital, Montpellier

Currently, the fitting of hearing aids is using a computer interface that allows to adjust the gain and compression of acoustic amplification. This adjustment is made face to face, patient and audiologist being located in a soundproof space to test the effectiveness of the hearing aid.

However, advances in telemedicine in this context, let consider the possibility of addressing these hearing aids fitting via the same computer interface, but remotely controlled by the hearing care professional. The purpose of this study is to assess the ability to perform these tests no longer in front of the patient settings, but away from it, and without visual and sound contact other than through a computer interface.

At the end, this project wants to show that a remote fitting is an acceptable procedure that provides comparable results to-face fitting in terms of speech perception, speech in noise audiometry, hearing loss related quality of life in order to be able to offer this type of strategy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Background and rationale:

    Currently, the fitting of hearing aids is using a computer interface that allows to adjust the gain and compression of acoustic amplification. This adjustment is made face to face, patient and audiologist being located in a soundproof space to test the effectiveness of the hearing aid.

    However, advances in telemedicine in this context, let consider the possibility of addressing these hearing aids fitting via the same computer interface, but remotely controlled by the hearing care professional. The purpose of this study is to assess the ability to perform these tests no longer in front of the patient settings, but away from it, and without visual and sound contact other than through a computer interface.

  2. Objectives Main objective: To show that the remote fitting of hearing aids using the platform developed by AudioProConnect provides speech perception scores similar to those obtained by a face-control, after 5 weeks of use among experienced hearing aid users.

    Secondary Objectives: To compare the duration and the quality of both types of fitting, speech in noise testing, deafness related quality of life and assess the wearing time of hearing aids.

  3. Methods DESIGN: Biomedical research on health product, prospective, multicenter, randomized, and crossover study to assess the remote fitting of hearing aids: Study REFIT-HEARING Study Population: adults with bilateral hearing aids. Inclusion criteria: Patient aged between 18 and 85 years old, with hearing loss and using two hearing aids for more than one year, and compatible with AudioProConnect platform.

    Exclusion criteria: Patient with fluctuations of pure tone audiometry, cognitive disorders or severe speech disorders. Patient unable to move in an audiology laboratory.

    Primary Outcome: Evaluation of speech perception score with PBK test free-field at 60 dB.

    Secondary endpoints: assessment of quality control by measuring the pitch gain, duration of fitting in minutes, speech in noise audiometry, the wearing time of hearing aids in hours, the quality of life related to hearing loss via the APHAB questionnaire.

    Number of patients: 60 subjects Procedure (number of visits, length of inclusions, duration of follow-up, study schedule patient visits content, brief description of intervention): After the investigator has verified the criteria of inclusion / non inclusion and the subject has signed the written informed consent, the subject will be followed for a period ranging from 2 months to 5 months, during which he attended four visits in a audiology laboratory referenced in this project. During these visits, a fitting of hearing aids face to face or remotely will be realized, and it will be asked to answer a questionnaire to assess quality of life between the two fitting techniques.

    Study Schedule:

    Inclusion period: 3 months (M3-M6) Duration of the study for one subject: 2 months to 5 months (M6 to M8 or M6 to M11) Duration statistical analysis / recovery: 3 months (M11-M14) Global Study duration: 14 months

  4. Outlook At the end, this project wants to show that a remote fitting provides comparable results to-face fitting in terms of speech perception, in order to be able to offer this type of strategy.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34090
        • Hôpital Gui de Chauliac - Service ORL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age limits ≥ 18 et < 85 years
  • User of two hearing aids for more than a year
  • Carriers of adjustable digital hearing aids by means of a software of the usable manufacturer on Windows® PC (in stand-alone or as plug-in in the software NOAH®) to be integrated into the platform AudioProConnect. It is the case of almost all the current hearing aids (Phonak, Starkey, Siemens, Unitron, etc.)
  • Subject able to understand the nature, the aim and the methodology of the study.
  • Affiliation or recipient with the mode of social security.
  • Collection of the informed consent

Exclusion Criteria:

  • Fluctuations in the tonal audiometry, defined as variations furthermore of 10 dB of the average hearing loss (Average arithmetic of thresholds in 500, 1000, 2000 et 4000 Hz) Between the last 2 tonal audiometries realized over the previous 2 years
  • Cognitive disorders or severe phasic hampering the understanding of the language or the repetition of the speech (Subject not being capable of participating in a vocal audiometry during the last regulation of its hearing aids)
  • Incapacitated to move in a laboratory of audioprosthesis
  • Fickle bearing of the hearing aid (<6h /day ou < 5day/7)
  • Tip not adapted little finger
  • Presence of plugs of earwax at the time of the tests
  • Patient minor(miner) or protected adults or in the incapacity to give its consent according to the article L1121-8 Of the Public Code of the Health (CSP)
  • Pregnant or breast-feeding women according to the article L1121-5 du CSP.
  • Vulnerable people according to the article L1121-6 du CSP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: face to face fitting
face to face fitting of hearing aids
Device: Remote fitting
remote fitting of hearing aids
Device: Face to face fitting
face to face fitting of hearing aids
Experimental: remote fitting
remote fitting of hearing aids
Device: Remote fitting
remote fitting of hearing aids
Device: Face to face fitting
face to face fitting of hearing aids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech perception
Time Frame: 5 months
score PBK test
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
speech in noise audiometry
Time Frame: 5 months
5 months
quality of life
Time Frame: 5 months
APHAB questionnaire
5 months
duration of fitting
Time Frame: 5 months
5 months
daily use of hearing aids
Time Frame: 5 months
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

AudioPro Connect
Alliance Audition Montpellier
Audition Conseil Perpignan
Audition Conseil à Nîmes

Investigators

  • Principal Investigator: Frédéric VENAIL, Professor, University Hospital, Montpellier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 21, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 21, 2018

Last Update Submitted That Met QC Criteria

May 18, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9594

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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