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

December 11, 2023 updated by: Concha Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95192
        • San Jose State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Screening, intake and first fit (either clinician-fitting or self-fitting )
This clinical trial compares two methods of fitting individuals who suffer from hearing loss with a hearing aid device. Subjects will wear the hearing aid after receiving the clinician-fitting (device fitted by a clinician according to standard clinical best practice procedures) and self-fitting (device fitted by the user directly without assistance from a clinician following an automated assessment and fitting process) for two weeks each, totaling to approximately 1 month of wear throughout the trial. During the first visit, all individuals will go through intake procedures and a basic audiologic evaluation. After this is completed, individuals will be randomly assigned into one of two arms of the study. Individuals in the first visit of the study, will receive either the clinician-fitting or the self-fitting method for the first two weeks, then will switch to the experimental self-fitting or the clinician-fitting method for the last half. The order of the fitting will be randomized.
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
Sham Comparator: Second fit (either clinician-fitting or self-fitting )
In the second visit of the study, individuals who randomly received the conventional clinician-fitting for the first two weeks (first period) will switch to the experimental self-fitting for the remainder of the study (second period). Conversely, individuals who received the experimental self-fitting method for the first two weeks (first period) will switch to the clinician-fitting method for the last two weeks (second period). The same within-subject crossover design will be followed in both clinical sites and for all individuals who were enrolled in the study.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
QuickSIN
Time Frame: 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.
15 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
APHAB
Time Frame: 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.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Concha Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Minnesota
San Jose State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peggy Nelson, PhD, University of Minnesota
  • Principal Investigator: Anusha Yellamsetty, PhD, San Jose State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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