REFIT Hearing: Remote Fitting of Hearing Aids
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

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.
    

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.
    

Intervention name(s): Remote fitting; Face to face fitting
Intervention type(s): Device; Device
Intervention description(s): remote fitting of hearing aids; face to face fitting of hearing aids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: hearing loss; hearing aids