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

Not Applicable

Completed

• Conditions: Hearing Loss

• Registration Number: NCT06167161
• Lead Sponsor: Concha Inc.

Brief 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.

Study Timeline

• Study Start: 2023-01-30
• Primary Completion: 2023-05-30
• Study Completion: 2023-05-30
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
QuickSIN	15 days	A standardized measure of speech communication in noise, Quick Speech-in-Noise. (QuickSIN). Scores are clinically reported as SNR loss, the difference (in dB) between a listener's performance and that of normal-hearing adult controls. The SNR loss score is an indication of an individual's overall degree of difficulty understanding speech in noise. The greater the SNR loss the poorer the listener's ability is to hear in noise. The QuickSIN test manual provides adjective descriptors corresponding to the SNR loss score where an SNR loss score of 0 to 2 dB is normal, 2 to 7 dB is mild, 7 to 15 dB is moderate, and greater than 15 dB is defined as severe.

Secondary Outcome Measures

Name	Time	Method
APHAB	15 days	Self-report scale according to the Abbreviated Profile of Hearing Aid Benefit (APHAB). The APHAB is a self-report scale consisting of 24 Likert scale questions and is composed of four subscales including Ease of Communication (EC), Reverberation (RV), Background Noise (BN), and Aversiveness (AV). This outcome measure assesses residual activity limitations for hearing impaired individuals and it ranges from Never (1%) to Always (99%). APHAB scores represent how frequently clients experience performance problems and therefore a high APHAB score reflects a worse outcome.

Trial Locations

Locations (2)

San Jose State University; 🇺🇸 San Jose, California, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States