Hearing Loss Clinical Trial
Official title:
REFIT Hearing: Remote Fitting of Hearing Aids
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.
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.
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