Clinical Evaluation of Hearing Aid OTC Self-Assessment Methods for Adults With Perceived Mild-to-Moderate Hearing Loss

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRehear Audiology Company LTD

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

24 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Rehear Audiology Company LTD

Lead sponsor

Global Edge Medtech Consulting

Collaborator

National Acoustic Laboratories

Collaborator