REFIT Hearing: Remote Fitting of Hearing Aids
REFITHEARING
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
1 active site
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
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 21, 2018
May 1, 2018
7 months
October 21, 2015
May 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
speech perception
score PBK test
5 months
Secondary Outcomes (4)
speech in noise audiometry
5 months
quality of life
5 months
duration of fitting
5 months
daily use of hearing aids
5 months
Study Arms (2)
face to face fitting
ACTIVE COMPARATORface to face fitting of hearing aids
remote fitting
EXPERIMENTALremote fitting of hearing aids
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- AudioPro Connectcollaborator
- Alliance Audition Montpelliercollaborator
- Audition Conseil Perpignancollaborator
- Audition Conseil à Nîmescollaborator
Study Sites (1)
Hôpital Gui de Chauliac - Service ORL
Montpellier, 34090, France
Related Publications (1)
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.
PMID: 31694484DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric VENAIL, Professor
University Hospital, Montpellier
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 28, 2015
Study Start
October 1, 2015
Primary Completion
May 1, 2016
Study Completion
December 1, 2016
Last Updated
May 21, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share