Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid

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.

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.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 18 years of age or older
* Apple iPhone X or newer (iOS 14 compatible or greater)
* Mix of male and female subjects
* Willing and able to perform all tests required for the study
* Signed and dated informed consent before the start of any study specific procedure
* Able to read and comprehend English
* Mild-to-moderate bilateral sensorineural hearing loss (defined according to thresholds from 250-8000 Hz with at least one threshold greater than 20 dB HL and thresholds at 500, 1000, 2000 and 4000 Hz less than or equal to 55, 65, 70, and 80 dB HL, respectively)

Exclusion Criteria:

* Hearing outside of limits noted, above
* Visible deformities of the ear since birth or from injury
* Fluid, pus, or blood coming out of the ear within the previous six months
* Sudden, quickly worsening, or fluctuating hearing loss within the previous six months
* Dizziness or periodic vertigo associated with hearing loss
* Hearing loss in only one ear or a large difference in hearing between ears
* Ear wax build up or feeling that something is in the ear canal
* Pain or discomfort in the ear
* Inability to follow the procedures of the study due to language problems, or other cognitive problems
* Any other history of chronic middle and outer ear disease