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Hearing LossREFITHEARINGNCT02589561

REFIT Hearing: Remote Fitting of Hearing Aids

A study testing Remote fitting and Face to face fitting in people with Hearing Loss, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 84 years
Conditions the study is for
Hearing Loss
What is being tested?
Remote fitting and Face to face fitting
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
Oct 2015to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 84 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Hôpital Gui de Chauliac - Service ORL

    Montpellier, 34090

Other trials in France

About this study

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.

Read the 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.
Conditions
Hearing Loss
Being tested
Remote fitting, Face to face fitting
Keywords
hearing loss, hearing aids
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Remote fittingDevice

    remote fitting of hearing aids

  • Face to face fittingDevice

    face to face fitting of hearing aids

Study groups in NCT02589561
Study groupRoleWhat they receive
face to face fittingActive comparatorface to face fitting of hearing aids
Receives: Device: Remote fitting; Device: Face to face fitting
remote fittingExperimentalremote fitting of hearing aids
Receives: Device: Remote fitting; Device: Face to face fitting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. speech perception

    score PBK test

    Measured: 5 months

Secondary outcomes (4)

  1. speech in noise audiometry

    Measured: 5 months

  2. quality of life

    APHAB questionnaire

    Measured: 5 months

  3. duration of fitting

    Measured: 5 months

  4. daily use of hearing aids

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionMay 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02589561
Sponsor's protocol ID
9594
Acronym
REFITHEARING
Status last verified
May 2018
First submitted
21 Oct 2015
Last updated
21 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Venail F, Picot MC, Marin G, Falinower S, Samson J, Cizeron G, Balcon M, Blanc D, Bricaud J, Lorenzi A, Ceccato JC, Puel JL. Speech perception, real-ear measurements and self-perceived hearing impairment after remote and face-to-face programming of hearing aids: A randomized single-blind agreement study. J Telemed Telecare. 2021 Aug;27(7):409-423. doi: 10.1177/1357633X19883543. Epub 2019 Nov 6.

    PubMed 31694484

Questions about this trial

What is this clinical trial studying?

A study testing Remote fitting and Face to face fitting in people with Hearing Loss, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

speech perception (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02589561, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.

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