Hearing Loss, SensorineuralNCT05101083
Speech Intelligibility in Quiet and Noise for New vs. Legacy Hearing Aids
A study testing New Receiver-in-Canal Device and Legacy Receiver-in-Canal Device in people with Hearing Loss, Sensorineural and Hearing Loss, run by Starkey Laboratories, Inc at 1 site in United States.
Trial summary
This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Sensorineural, Hearing Loss
- What is being tested?
- New Receiver-in-Canal Device and Legacy Receiver-in-Canal Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 10 Jan 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults, minimum age of 18
- Native English speakers
- Ability to complete questionnaires and laboratory assessments
- Symmetric, mild to moderately-severe sensorineural hearing loss
- Informed consent completed with signature
Who cannot join
- Inability to visit the Starkey Headquarters building for testing
- Central or middle ear hearing problems
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids
This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.
Read the detailed description
Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss
- Being tested
- New Receiver-in-Canal Device, Legacy Receiver-in-Canal Device
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Receiver-in-Canal DeviceDevice
Successor of previous device generation
Legacy Receiver-in-Canal DeviceDevice
Receiver-in-canal device available on the market
| Study group | Role | What they receive |
|---|---|---|
| Hearing Aid 1 | Experimental | New Receiver-in-Canal device, successor of previous device generation Receives: Device: Legacy Receiver-in-Canal Device |
| Hearing Aid 2 | Active comparator | Legacy Receiver-in-Canal device that is currently available on the market Receives: Device: New Receiver-in-Canal Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure.
Measured: Four weeks
Secondary outcomes (2)
First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids
This data will be collected through lab testing following the first fit of the hearing aids. Participants will answer questionnaire items related to their impressions of sound quality. Results will be collected using a 7-point Likert scale, and ratings (1-7) will be analyzed using descriptive statistics. Statistical measures for repeated measurements will be used to understand any differences between hearing aid conditions.
Measured: Four weeks
Safety of the new, receiver-in-canal devices through tracking of adverse events
This data will be collected through the tracking of adverse events.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start25 Oct 2021
- Primary completion10 Jan 2022
- Study completion10 Jan 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
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Starkey Laboratories, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101083
- Sponsor's protocol ID
- PR 21001
- Status last verified
- Jan 2022
- First submitted
- 18 Oct 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speech Intelligibility in Quiet and Noise for New Versus Legacy Hearing Aids
- ClinicalTrials.gov ID
- NCT05101083
- Acronym / sponsor ID
- PR 21001
- Conditions
- Hearing Loss, Sensorineural, Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Starkey Laboratories, IncIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 1 Nov 2021 (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.
This clinical investigation is designed to compare audiological performance (i.e., measurements of sound quality and speech understanding) between Starkey's new receiver-in-canal device and a commercially available legacy receiver-in-canal device.
Detailed description
Starkey is investigating a new hearing aid with several new audiological features. These features have been assessed for benefit, individually, but this clinical investigation will serve as a test for safety and efficacy with all hearing aid features, together. The design of this study is a single-blinded, crossover design and will be conducted at Starkey's headquarters in Eden Prairie, MN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Crossover Assignment - Each participant will experience both test conditions (counterbalanced)
| Arm | Type | Receives |
|---|---|---|
| Hearing Aid 1 | Experimental | Device: Legacy Receiver-in-Canal DeviceNew Receiver-in-Canal device, successor of previous device generation |
| Hearing Aid 2 | Active comparator | Device: New Receiver-in-Canal DeviceLegacy Receiver-in-Canal device that is currently available on the market |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults, minimum age of 18
- Native English speakers
- Ability to complete questionnaires and laboratory assessments
- Symmetric, mild to moderately-severe sensorineural hearing loss
- Informed consent completed with signature
Key exclusion criteria (4 listed)
- Inability to visit the Starkey Headquarters building for testing
- Central or middle ear hearing problems
- 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
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 |
|---|---|---|
| New Receiver-in-Canal DeviceSuccessor of previous device generation | Device | Hearing Aid 2 |
| Legacy Receiver-in-Canal DeviceReceiver-in-canal device available on the market | Device | Hearing Aid 1 |
Primary outcome
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids
Time frame: Four weeks
IEEE sentences will be presented to the research participants in quiet and in background noise. The percent words repeated back correctly will be scored and serve as the reported result of this outcome measure.
2 secondary outcomes
First fit ratings of sound quality on subjective questionnaires for the new vs. legacy hearing aids
Time frame: Four weeks
Safety of the new, receiver-in-canal devices through tracking of adverse events
Time frame: Four weeks
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 Jan 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Receiver-in-Canal Device and Legacy Receiver-in-Canal Device in people with Hearing Loss, Sensorineural and Hearing Loss, 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 5 inclusion and 4 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 Jan 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?
Speech intelligibility (% words repeated back correctly) in quiet and noise for new vs. legacy hearing aids (time frame: Four 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 18 Jan 2022.