Hearing LossNCT05527730
Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids
A study testing Comparison of PRO-FIT or SELF-FIT fitting in people with Hearing Loss, run by Whisper.ai at 1 site in United States.
Trial summary
Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Whisper.ai Inc has previously brought to market a commercial hearing aid system that reduces background noise and amplifies voices and sounds of interest using its proprietary platform based on machine… 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?
- Comparison of PRO-FIT or SELF-FIT fitting
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to 20 Dec 2022
- 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 age 18-80 years old
- Mild-to-moderate hearing loss in both ears from 500 to 4000 Hz
- Reported one year of previous hearing aid experience in at least one ear
- Ability to use a laptop/desktop computer to browse the internet
- Ability to complete online surveys in a web browser
- Communicates verbally and in writing in English
Who cannot join
- History of neurological deficits (e.g. stroke, Alzheimer's disease, etc.)
- Inability to remain alert throughout initial testing appointment
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Whisper.ai
San Francisco, California, 94103
About this study
Approximately 48 million people in the United States have hearing loss or hearing difficulties in noisy environments. Whisper.ai Inc has previously brought to market a commercial hearing aid system that reduces background noise and amplifies voices and sounds of interest using its proprietary platform based on machine learning and artificial intelligence technologies.
Whisper.ai Inc now seeks to bring to market a new hearing system that will incorporate a "self-fitting" capability. Self-fitting hearing aids have emerged in recent years as a potentially viable option to calibrate hearing aids to the needs of individual users without clinician intervention. The purpose of this project is to evaluate the efficiency and reliability of the fitting procedure and algorithms developed by Whisper.ai Inc. The study will be carried out using a randomized crossover design in two phases: in phase 1, subjects will be tested and a hearing aid will be fitted using conventional audiological standard procedures , and in phase 2, the subject will be tested and a hearing aid will be fitted using the results of the self-fitting algorithm.
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 algorithm. The investigators expect the fitting results of the Whisper.ai self-fitting algorithm to be similar to those of standardized fitting procedures conducted by hearing professionals.
- Conditions
- Hearing Loss
- Being tested
- Comparison of PRO-FIT or SELF-FIT fitting
- Keywords
- Self-fitting hearing aids, conventional hearing aid 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.
Comparison of PRO-FIT or SELF-FIT fittingDevice
Also called SELF-FIT fitting, PRO-FIT fitting
add
| Study group | Role | What they receive |
|---|---|---|
| Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting ) | Active comparator | This multi-center, prospective, randomized cross-over clinical trial compares two methods of fitting individuals with hearing loss with a therapeutic amplification device (i.e., hearing aids). Subjects will wear the Whisper Hearing System for the PRO-FIT and SELF-FIT for two weeks each, totalling to approximately 1 month of wear throughout the trial. At the first visit, all individuals will go through intake procedures and a basic audiologic evaluation. After this is completed, individuals are randomized into one of two arms of the study Individuals in the first visit of the study will receive the conventional PRO-FIT method for the first two weeks, then will switch to the experimental SELF-FIT method for the last half of the study. Receives: Device: Comparison of PRO-FIT or SELF-FIT fitting |
| Second fit (either PRO-FIT or SELF-FIT fitting ) | Sham comparator | Conversely, individuals in the second visit of the study will receive the experimental SELF-FIT method for the first two weeks, then will switch to the conventional PRO-FIT method for the last two weeks. The two fitting methods (PRO-FIT and SELF-FIT) will be compared to evaluate the efficiency and reliability of the Whisper hearing system self-fitting algorithm. Receives: Device: Comparison of PRO-FIT or SELF-FIT fitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan
To evaluate, fine-tune, and compare the gains produced by the Whisper Hearing System using both PRO-FIT and SELF-FIT, general standard-of-care real-ear measurements (REM) will be used. Real Ear Measures (REMs) provide an objective measure of sound pressure level in an individual's ear canal. Frequencies critical to speech understanding (500 through 4000 Hz) will be averaged to yield a single value similar to a pure tone average. A mean absolute difference will be used to evaluate whether the SELF-FIT is non-inferior to the PRO-FIT; a mean absolute difference less than 5 dB will be considered as a non-significant difference when comparing REMs between the SELF-FIT and PRO-FIT groups.
Measured: 4 weeks
Secondary outcomes (2)
Speech perception scores comparison
The Quick Speech In Noise (QuickSIN) will provide a behavioral measure that will be compared across fitting conditions.The outcome of a non-inferiority trial may be assessed by a two-sided t-test, using a 95% confidence interval. A two-sided t-test will be used to compare the two final Quick Speech in Noise scores across fitting groups.Minimum value: -4.5 SNR Loss Maximum value: 25.5 SNR Loss Lower score here is better performance/outcome (-4.5 is the best possible score).
Measured: 2 hours for the testing, 4 weeks trial
Overall perception hearing
Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item self-assessment inventory in which subjects report the amount of trouble they are having with communication or noises in various everyday situations. The APHAB produces scores for 4 subscales: Ease of Communication, Reverberation, Background Noise, and Aversiveness. These are combined to create a global score, which will be used to evaluate the overall benefit of amplification for each fitting strategy (SELF-FIT and PRO-FIT).
The outcome of a non-inferiority trial may be assessed by a two-sided t-test, using a 95% confidence interval. A two-sided t-test with 95% confidence intervals will be used to determine whether APHAB outcomes differ between the SELF-FIT and the PRO-FIT.
Minimum value: 0% of problems Maximum value: 100% of problems Lower score here is a lower percent of problems, or better performance/outcome.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start7 Jul 2022
- Primary completion10 Dec 2022 (estimated)
- Study completion20 Dec 2022 (estimated)
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 multi-center, prospective, randomized cross-over clinical trial compares two methods of fitting individuals with hearing loss with a therapeutic amplification device (i.e., hearing aids). Subjects will wear the Whisper Hearing System for the PRO-FIT and SELF-FIT for two weeks each, totalling to approximately 1 month of wear throughout the trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Whisper.ai
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- San Jose State University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527730
- Sponsor's protocol ID
- DM0224
- Status last verified
- Dec 2022
- First submitted
- 21 Jul 2022
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluating Outcomes of Self-Fit and Professionally Fit Hearing Aids
- ClinicalTrials.gov ID
- NCT05527730
- Acronym / sponsor ID
- DM0224
- Conditions
- Hearing Loss
- Keywords
- Self-fitting hearing aids, conventional hearing aid fitting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Whisper.aiIndustry (pharma, biotech, devices)
- Collaborators
- San Jose State University
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 10 Dec 2022 (estimated)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 2 Sep 2022 (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. Whisper.ai Inc has previously brought to market a commercial hearing aid system that reduces background noise and amplifies voices and sounds of interest using its proprietary platform based on machine learning and artificial intelligence technologies.
Whisper.ai Inc now seeks to bring to market a new hearing system that will incorporate a "self-fitting" capability. Self-fitting hearing aids have emerged in recent years as a potentially viable option to calibrate hearing aids to the needs of individual users without clinician intervention. The purpose of this project is to evaluate the efficiency and reliability of the fitting procedure and algorithms developed by Whisper.ai Inc. The study will be carried out using a randomized crossover design in two phases: in phase 1, subjects will be tested and a hearing aid will be fitted using conventional audiological standard procedures , and in phase 2, the subject will be tested and a hearing aid will be fitted using the results of the self-fitting algorithm.
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 algorithm. The investigators expect the fitting results of the Whisper.ai self-fitting algorithm to be similar to those of standardized fitting procedures conducted by hearing professionals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This multi-center, prospective, randomized cross-over clinical trial compares two methods of fitting individuals with hearing loss with a therapeutic amplification device (i.e., hearing aids). Subjects will wear the Whisper Hearing System for the PRO-FIT and SELF-FIT for two weeks each, totalling to approximately 1 month of wear throughout the trial.
| Arm | Type | Receives |
|---|---|---|
| Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting ) | Active comparator | Device: Comparison of PRO-FIT or SELF-FIT fittingThis multi-center, prospective, randomized cross-over clinical trial compares two methods of fitting individuals with hearing loss with a therapeutic amplification device (i.e., hearing aids). Subjects will wear the Whisper Hearing System for the PRO-FIT and SELF-FIT for two weeks each, totalling to approximately 1 month of wear throughout the trial. At the first visit, all individuals will go through intake procedures and a basic audiologic evaluation. After this is completed, individuals are randomized into one of two arms of the study Individuals in the first visit of the study will receive the conventional PRO-FIT method for the first two weeks, then will switch to the experimental SELF-FIT method for the last half of the study. |
| Second fit (either PRO-FIT or SELF-FIT fitting ) | Sham comparator | Device: Comparison of PRO-FIT or SELF-FIT fittingConversely, individuals in the second visit of the study will receive the experimental SELF-FIT method for the first two weeks, then will switch to the conventional PRO-FIT method for the last two weeks. The two fitting methods (PRO-FIT and SELF-FIT) will be compared to evaluate the efficiency and reliability of the Whisper hearing system self-fitting algorithm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults age 18-80 years old
- Mild-to-moderate hearing loss in both ears from 500 to 4000 Hz
- Reported one year of previous hearing aid experience in at least one ear
- Ability to use a laptop/desktop computer to browse the internet
- Ability to complete online surveys in a web browser
Key exclusion criteria (2 listed)
- History of neurological deficits (e.g. stroke, Alzheimer's disease, etc.)
- Inability to remain alert throughout initial testing appointment
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 |
|---|---|---|
| Comparison of PRO-FIT or SELF-FIT fittingAlso: SELF-FIT fitting, PRO-FIT fittingadd | Device | Screening, intake and first fit (either PRO-FIT or SELF-FIT fitting ), Second fit (either PRO-FIT or SELF-FIT fitting ) |
Primary outcome
Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan
Time frame: 4 weeks
To evaluate, fine-tune, and compare the gains produced by the Whisper Hearing System using both PRO-FIT and SELF-FIT, general standard-of-care real-ear measurements (REM) will be used. Real Ear Measures (REMs) provide an objective measure of sound pressure level in an individual's ear canal. Frequencies critical to speech understanding (500 through 4000 Hz) will be averaged to yield a single value similar to a pure tone average. A mean absolute difference will be used to evaluate whether the SELF-FIT is non-inferior to the PRO-FIT; a mean absolute difference less than 5 dB will be considered as a non-significant difference when comparing REMs between the SELF-FIT and PRO-FIT groups.
2 secondary outcomes
Speech perception scores comparison
Time frame: 2 hours for the testing, 4 weeks trial
Overall perception hearing
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of PRO-FIT or SELF-FIT fitting in people with Hearing Loss, run by Whisper.ai at 1 site 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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Becky Lewis, PhD (8449364327, becky@whisper.ai), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing aid gain comparisons using Real Ear Measures Data Analysis Plan (time frame: 4 weeks). 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 7 Dec 2022.