Clinical Evaluation of the RH210 Hearing Aid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRehear Audiology Company LTD
About this trial
The RH210A is an air-conduction hearing aid designed for adults with perceived mild-to-moderate sensorineural hearing loss. The purpose of this clinical investigation is to generate objective and subjective evidence of the clinical performance and safety of the device.
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
- Investigational device (RH210A)
- Apple AirPods Pro (2nd Generation) with Hearing Aid Feature (HAF)
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
Rehear Audiology Company LTD
Lead sponsor
Global Edge Medtech Consulting
Collaborator
National Acoustic Laboratories
Collaborator
Source ClinicalTrials.gov