Hearing LossNCT06167161
Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid
A study testing Hearing aid in people with Hearing Loss, run by Concha Inc. at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Hearing aid
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2023to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Minnesota
Minneapolis, Minnesota, 55455
San Jose State University
San Jose, California, 95192
About this study
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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Hearing aid
- Keywords
- air-conduction hearing aid, over-the-counter, self-fitting
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aidDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Screening, intake and first fit (either clinician-fitting or self-fitting ) | Active comparator | 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. Receives: Device: Hearing aid |
| Second fit (either clinician-fitting or self-fitting ) | Sham comparator | 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. Receives: Device: Hearing aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (1)
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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start30 Jan 2023
- Primary completion30 May 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This investigation will incorporate a within-subject, randomized, crossover study design in which all study participants will complete two different study arm conditions. During the first visit, subjects will be randomly allocated to study arm A (clinician-fitting) or study arm B (self-fitting). Following the initial two-week take-home field trial, the research participants will be assigned to the opposite study arm such that a complete two-sequence crossover design (AB/BA design) will be followed. The same within-subject crossover design will be followed in both clinical sites and for all individuals who will be enrolled in the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concha Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota, San Jose State University
- Responsible party
- Sponsor
- Investigators
- Peggy Nelson, PhD, Principal investigator, University of MinnesotaAnusha Yellamsetty, PhD, Principal investigator, San Jose State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167161
- Sponsor's protocol ID
- PROT-001
- Status last verified
- Dec 2023
- First submitted
- 4 Dec 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation and Validation of a Self-fitted Air-conduction Hearing Aid
- ClinicalTrials.gov ID
- NCT06167161
- Acronym / sponsor ID
- PROT-001
- Conditions
- Hearing Loss
- Keywords
- air-conduction hearing aid, over-the-counter, self-fitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Concha Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota, San Jose State University
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This investigation will incorporate a within-subject, randomized, crossover study design in which all study participants will complete two different study arm conditions. During the first visit, subjects will be randomly allocated to study arm A (clinician-fitting) or study arm B (self-fitting). Following the initial two-week take-home field trial, the research participants will be assigned to the opposite study arm such that a complete two-sequence crossover design (AB/BA design) will be followed. The same within-subject crossover design will be followed in both clinical sites and for all individuals who will be enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| Screening, intake and first fit (either clinician-fitting or self-fitting ) | Active comparator | Device: Hearing aidThis 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. |
| Second fit (either clinician-fitting or self-fitting ) | Sham comparator | Device: Hearing aidIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing aidThe 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 | Device | Screening, intake and first fit (either clinician-fitting or self-fitting ), Second fit (either clinician-fitting or self-fitting ) |
Primary outcome
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.
1 secondary outcome
APHAB
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Nelson, PhD principal investigator
University of Minnesota
Anusha Yellamsetty, PhD principal investigator
San Jose State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid in people with Hearing Loss, run by Concha Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QuickSIN (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.