- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167161
Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Jose, California, United States, 95192
- San Jose State University
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
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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.
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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
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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.
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
QuickSIN
Time Frame: 15 days
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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.
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15 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
APHAB
Time Frame: 15 days
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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.
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15 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peggy Nelson, PhD, University of Minnesota
- Principal Investigator: Anusha Yellamsetty, PhD, San Jose State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PROT-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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