Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Approximately 48 million people in the United States have hearing loss or hearing
      difficulties in noisy environments. Concha Inc. is working on introducing a wireless
      air-conduction hearing aid to the market, featuring a self-fitting feature. Self-fitting
      hearing aids have emerged in recent years as a potentially viable option towards addressing
      unmet hearing health care needs for millions of individuals who suffer from mild-to-moderate
      hearing loss. The purpose of this study is to evaluate the efficiency and reliability of the
      self-fitting strategy developed by Concha Inc.
    

Detailed description: 
      The clinical study will be carried out using a within-subject, randomized, crossover study
      design in which all study participants will complete two different study arm conditions
      (clinician-fitting and self-fitting). Objective, subjective, and behavioral responses will be
      gathered from a variety of hearing-related surveys and tests, and will be analyzed
      quantitatively to evaluate the efficiency and reliability of the self-fitting procedure
      developed by Concha Inc.

      The Quick Speech-in-Noise (QuickSIN) Test will be used as the primary effectiveness endpoint.
      QuickSIN is a quick and easy test that can measure an individual's ability to understand
      speech in noise. The secondary effectiveness endpoint will be assessed by using the
      Abbreviated Profile of Hearing Aid Benefit (APHAB). The APHAB was designed to evaluate the
      effect of hearing impairment or benefit in daily life APHAB and has long been considered the
      gold standard for patient-reported perceived benefit.

      For this clinical study to be deemed successful, the self-fitting method needs to yield
      outcomes (namely QuickSIN and APHAB scores) which are non-inferior to the clinician-fitting
      method. Non-inferiority refers to an outcome where the new intervention (in our case,
      self-fitting) is not significantly worse than the established intervention (in our case,
      clinician-fitting), while also accounting for a clinically-significant margin.
    

Intervention name(s): Hearing aid
Intervention type(s): Device
Intervention description(s): The hearing aid is a receiver-in-canal style hearing aid which can be programmed and adjusted by proprietary software and through a dedicated smartphone application
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This investigation will incorporate a within-subject, randomized, crossover study design in which all study participants will complete two different study arm conditions. During the first visit, subjects will be randomly allocated to study arm A (clinician-fitting) or study arm B (self-fitting). Following the initial two-week take-home field trial, the research participants will be assigned to the opposite study arm such that a complete two-sequence crossover design (AB/BA design) will be followed. The same within-subject crossover design will be followed in both clinical sites and for all individuals who will be enrolled in the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: air-conduction hearing aid; over-the-counter; self-fitting