About this trial
The goal of this clinical trial is to compare two methods of self assessment of hearing with conventional audiometry in an OTC Hearing Aid for adults with perceived mild to moderate hearing loss. The main questions it aims to answer are:
1. To evaluate agreement between prescribed gain outputs generated from conventional audiometry and those generated from the self-assessment response method. 2. Determine whether either self-assessment response method provides acceptable estimated audibility. 3. Evaluate participant preference between the detection response method and the audibility-release response method.
Researchers will compare the two novel methods with conventional audiometry to determine levels of agreement.
Participants will self assess their hearing methods using two novel methods of hearing assessment as well as receive a conventional audiometric evaluation of hearing levels.
Eligibility criteria
Qualifiers
Age 18 years
Self-perceived mild-to-moderate hearing difficulties/ hearing loss
Competent smartphone use (able to complete self-fitting via the app)
Able and willing to provide informed consent
Disqualifiers
Conductive or mixed hearing loss
Occluding cerumen
Otologic disease/ active ear pathology
Severe or profound hearing loss (PTA >S0dBHL) (WHO, 2021)
Trial design
Treatments tested in this trial
- OTC Hearing Aid Self Fitting App
- Audiometry
Treatment groups
Sponsors and collaborators
Rehear Audiology Company LTD
Lead sponsor
Global Edge Medtech Consulting
Collaborator
National Acoustic Laboratories
Collaborator