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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06167161
• Other study ID #: PROT-001
• Status: Completed
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: May 30, 2023

Study information

• Verified date: December 2023
• Source: Concha Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Hearing aid
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

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota
United States	San Jose State University	San Jose	California

Sponsors (3)

Lead Sponsor	Collaborator
Concha Inc.	San Jose State University, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QuickSIN	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.	15 days
Secondary	APHAB	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.	15 days