Hearing Loss, SensorineuralNCT05612763
Self Fitting Hearing Aid Clinical Investigation
A study testing Self fitting hearing device in people with Hearing Loss, Sensorineural, run by Starkey Laboratories, Inc at 1 site in United States.
Trial summary
Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- Self fitting hearing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 10 Oct 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Native English speakers
- Ability to complete questionnaires and laboratory assessments
- Symmetric, mild to moderate sensorineural hearing loss
- Informed consent completed with signature
- Healthy outer ear/middle ear status
- Limited hearing aid use (non-owners of hearing aids)
Who cannot join
- Inability to visit the Starkey Headquarters building for testing
- Central or middle ear hearing pathology
- Medical contraindications to wearing hearing aids
- Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
- Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural hearing loss)
Trial locations and contacts
1 site in 1 country.
About this study
Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids
Read the detailed description
The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- Self fitting hearing device
- Keywords
- self fitting
- Medical subject headings
- Hearing Loss, Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self fitting hearing deviceDevice
comparison of outcomes when device is fit by clinician or self fit
| Study group | Role | What they receive |
|---|---|---|
| Method of fit | Experimental | Devices are fit using either a clinician completed fitting process or a patient completed fitting process. Then the alternate fitting method is used to repeat the process. The order of which method used is counterbalanced. Receives: Device: Self fitting hearing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)
This data will be collected through the APHAB (Abbreviated Profile of Hearing Aid Benefit). This is a 24-item survey of hearing aid benefit. This test will be administered in the unaided hearing aid condition, and in both the traditional and new fitting method conditions. Scores report the reduction in reported problems, and a higher score shows a larger reduction in problems in one condition than the other.
Measured: The timeframe for this data collection will be unaided, and 14 days post-fitting.
Secondary outcomes (1)
1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)
This data will be collected with the QuickSIN, which is an adaptive measure of speech recognition in background noise. Outcome score is reported in "dB SNR loss." A reduced SNR loss is a better score and implies that the lower score performs better than the higher score.
Measured: Timeframe for this data collection will be unaided, and 14-days post-fitting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start18 Aug 2022
- Primary completion3 Oct 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The participants will have three lab sessions and two field trials. In the first session, every participant will receive PD and CD fittings. The wearing schedule orders for all the participants will be counterbalanced. For the first field trial, half of the participants will wear the hearing aids with PD and the other half of the participants will wear the hearing aids with CD. In session two, outcomes for the first hearing aid condition will be measured. Then, the participants will wear hearing aids with the other type of fitting strategy for the second field trial. After that, they will return to the lab for session 3, in which outcomes for the second hearing aid condition will be measured. Outcome measures include a self-report field evaluation (Abbreviated Profile of Hearing Aid Benefit, or APHAB) and a lab-based speech recognition test (Quick Speech-in-Noise Test, Quick-SIN).
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starkey Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michelle Hicks, PhD, Study director, VP education and Clinical Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612763
- Sponsor's protocol ID
- GQ-PRO-06093
- Status last verified
- Nov 2022
- First submitted
- 28 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Overall data that does not identify the individual will be made available upon request, and summaries of the study data and data analysis will be provided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Fitting Hearing Aid Clinical Investigation
- ClinicalTrials.gov ID
- NCT05612763
- Acronym / sponsor ID
- GQ-PRO-06093
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- self fitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Starkey Laboratories, IncIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 10 Nov 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.
Pre-market Clinical Investigation whose primary purpose is to evaluate efficacy and effectiveness of self-fitting hearing aids
Detailed description
The purpose of this study is to evaluate the outcomes of hearing aids with patient-driven fitting (PD) and clinician-driven fitting (CD). The participants will be 40 adults with mild to moderate symmetrical hearing loss. For each hearing aid fitting strategy, the participant will wear the hearing aids for 10 days. Lab and field outcomes will be measured. This study will determine if perceived hearing benefit and speech recognition performance with the PD fitting method is non-inferior to that with the CD fitting method.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants will have three lab sessions and two field trials. In the first session, every participant will receive PD and CD fittings. The wearing schedule orders for all the participants will be counterbalanced. For the first field trial, half of the participants will wear the hearing aids with PD and the other half of the participants will wear the hearing aids with CD. In session two, outcomes for the first hearing aid condition will be measured. Then, the participants will wear hearing aids with the other type of fitting strategy for the second field trial. After that, they will return to the lab for session 3, in which outcomes for the second hearing aid condition will be measured. Outcome measures include a self-report field evaluation (Abbreviated Profile of Hearing Aid Benefit, or APHAB) and a lab-based speech recognition test (Quick Speech-in-Noise Test, Quick-SIN).
| Arm | Type | Receives |
|---|---|---|
| Method of fit | Experimental | Device: Self fitting hearing deviceDevices are fit using either a clinician completed fitting process or a patient completed fitting process. Then the alternate fitting method is used to repeat the process. The order of which method used is counterbalanced. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Native English speakers
- Ability to complete questionnaires and laboratory assessments
- Symmetric, mild to moderate sensorineural hearing loss
- Informed consent completed with signature
- Healthy outer ear/middle ear status
Key exclusion criteria (5 listed)
- Inability to visit the Starkey Headquarters building for testing
- Central or middle ear hearing pathology
- Medical contraindications to wearing hearing aids
- Learning disability, major cognitive handicap, or serious neurological or psychiatric disease that would prevent or restrict participation, as determined by the PI or designee
- Hearing loss outside of the specified criteria (Mild to Moderate Sensorineural 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 |
|---|---|---|
| Self fitting hearing devicecomparison of outcomes when device is fit by clinician or self fit | Device | Method of fit |
Primary outcome
1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB)
Time frame: The timeframe for this data collection will be unaided, and 14 days post-fitting.
This data will be collected through the APHAB (Abbreviated Profile of Hearing Aid Benefit). This is a 24-item survey of hearing aid benefit. This test will be administered in the unaided hearing aid condition, and in both the traditional and new fitting method conditions. Scores report the reduction in reported problems, and a higher score shows a larger reduction in problems in one condition than the other.
1 secondary outcome
1. Speech intelligibility - Quick Speech in Noise Test (QuickSIN)
Time frame: Timeframe for this data collection will be unaided, and 14-days post-fitting.
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 10 Nov 2022.
- Individual participant dataSharing planned: No. Overall data that does not identify the individual will be made available upon request, and summaries of the study data and data analysis will be provided
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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.
Michelle Hicks, PhD study director
VP education and Clinical Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self fitting hearing device in people with Hearing Loss, Sensorineural, run by Starkey Laboratories, Inc 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 5 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 10 Nov 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. 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?
1. Perceived hearing aid benefit- Abbreviated Profile of Hearing Aid Benefit (APHAB) (time frame: The timeframe for this data collection will be unaided, and 14 days post-fitting.). 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 10 Nov 2022.