Hearing Loss, FunctionalNCT03511417
The Effectiveness of Over the Counter Hearing Products for Middle-Aged Adults
A study testing over-the-counter hearing device in people with Hearing Loss, Functional, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
The investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. Read more about this study
- Who is it for?
- Ages 40 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Functional
- What is being tested?
- over-the-counter hearing device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2018to 17 Jan 2020
- 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 40 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 40-64 years
- Mild to moderate high frequency hearing loss
- Learned English as a first language
Who cannot join
- Previous use of hearing aids
- Hearing loss/problems attributed to factors other than aging
- History of: neurologic disorder, middle-ear disease
- Score of < 26 on the Montreal Cognitive Assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Amherst
Amherst, Massachusetts, 01003
About this study
Official title: Aging and Speech Perception in Complex Listening Environments
The investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. Many people are unlikely to pay several thousand dollars for hearing aids but they likely would be more willing to try a possible solution that is less expensive. When faced with counseling these individuals, audiologists are at a loss regarding whether or not to suggest that they try this type of technology, since there is virtually no research available to verify that these devices actually are helpful, particularly for individuals with mild hearing loss. The hypothesis being tested is that personal sound amplifiers can improve functional hearing and decrease cognitive load in complex auditory environments.
Read the detailed description
The field trials in this project will require you to use OTC hearing devices for a specified period of time in both ears simultaneously, and in just one ear, with periodic lab-based re-evaluation. Each field trial will continue until asymptotic performance is identified (up to a maximum of 12 weeks). You will return to the lab for assessment every 2 weeks. During each visit, speech perception and subjective listening effort will be assessed. Depending upon the specific field trial, the investigators also will complete measures of cognitive load (via dual-task paradigms), spatial release from masking, and localization ability during each lab visit.
- Conditions
- Hearing Loss, Functional
- Being tested
- over-the-counter hearing device
- Medical subject headings
- Hearing Loss, Functional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
over-the-counter hearing deviceDevice
Individuals will use commercially-available over-the-counter hearing devices for specified periods of time.
| Study group | Role | What they receive |
|---|---|---|
| Middle-aged adults | Experimental | Participants will use an over-the-counter hearing device in one ear until asymptotic speech perception performance is noted (maximum 12 weeks). The same individuals will use over-the-counter hearing devices in each ear until asymptotic performance is noted (the order of these two phases will be randomized across participants). They will be asked to use these devices at least 4 hours/day. Receives: Device: over-the-counter hearing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech Perception
The change in the ability to understand sentences presented in background noise
Measured: every two weeks until asymptotic performance is noted (up to 12 weeks)
Cognitive Load
The change in the ability to remember speech that has previously been presented in background noise
Measured: every two weeks until asymptotic performance is noted (up to 12 weeks)
Localization Ability
The change in the ability to indicate where a sound is coming from when presented in background noise
Measured: every two weeks until asymptotic performance is noted (up to 12 weeks)
Self-Perceived Listening Effort
Changes in how difficult it is to understand speech in background noise
Measured: every two weeks until asymptotic performance is noted (up to 12 weeks)
Secondary outcomes (2)
Self-perceived hearing device benefit
The situations in which participants find the hearing aids to be beneficial
Measured: daily during field trial (up to 12 weeks)
Overall perceived benefit from hearing device
The extent to which participants believe the hearing devices help them
Measured: every two weeks until asymptotic performance is noted (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start16 Oct 2018
- Primary completion17 Jan 2020
- Study completion17 Jan 2020
Why it stopped: Due to the delay in establishing FDA regulations for over-the-counter hearing aids
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, FunctionalStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Helfer, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511417
- Sponsor's protocol ID
- R01DC012057-06
- Status last verified
- Oct 2021
- First submitted
- 9 Apr 2018
- Last updated
- 20 Oct 2021
- 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 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging and Speech Perception in Complex Listening Environments
- ClinicalTrials.gov ID
- NCT03511417
- Acronym / sponsor ID
- R01DC012057-06
- Conditions
- Hearing Loss, Functional
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the delay in establishing FDA regulations for over-the-counter hearing aids
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 17 Jan 2020 (actual)
- Study completion
- 17 Jan 2020 (actual)
- First posted
- 27 Apr 2018 (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.
The investigators will examine the effectiveness of selected over-the-counter personal sound amplifiers in addressing functional hearing problems in middle-aged listeners with mild hearing loss. Many people are unlikely to pay several thousand dollars for hearing aids but they likely would be more willing to try a possible solution that is less expensive. When faced with counseling these individuals, audiologists are at a loss regarding whether or not to suggest that they try this type of technology, since there is virtually no research available to verify that these devices actually are helpful, particularly for individuals with mild hearing loss. The hypothesis being tested is that personal sound amplifiers can improve functional hearing and decrease cognitive load in complex auditory environments.
Detailed description
The field trials in this project will require you to use OTC hearing devices for a specified period of time in both ears simultaneously, and in just one ear, with periodic lab-based re-evaluation. Each field trial will continue until asymptotic performance is identified (up to a maximum of 12 weeks). You will return to the lab for assessment every 2 weeks. During each visit, speech perception and subjective listening effort will be assessed. Depending upon the specific field trial, the investigators also will complete measures of cognitive load (via dual-task paradigms), spatial release from masking, and localization ability during each lab visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle-aged adults | Experimental | Device: over-the-counter hearing deviceParticipants will use an over-the-counter hearing device in one ear until asymptotic speech perception performance is noted (maximum 12 weeks). The same individuals will use over-the-counter hearing devices in each ear until asymptotic performance is noted (the order of these two phases will be randomized across participants). They will be asked to use these devices at least 4 hours/day. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 40-64 years
- Mild to moderate high frequency hearing loss
- Learned English as a first language
Key exclusion criteria (4 listed)
- Previous use of hearing aids
- Hearing loss/problems attributed to factors other than aging
- History of: neurologic disorder, middle-ear disease
- Score of < 26 on the Montreal Cognitive Assessment
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 |
|---|---|---|
| over-the-counter hearing deviceIndividuals will use commercially-available over-the-counter hearing devices for specified periods of time. | Device | Middle-aged adults |
Primary outcome
Speech Perception
Time frame: every two weeks until asymptotic performance is noted (up to 12 weeks)
The change in the ability to understand sentences presented in background noise
Cognitive Load
Time frame: every two weeks until asymptotic performance is noted (up to 12 weeks)
The change in the ability to remember speech that has previously been presented in background noise
Localization Ability
Time frame: every two weeks until asymptotic performance is noted (up to 12 weeks)
The change in the ability to indicate where a sound is coming from when presented in background noise
Self-Perceived Listening Effort
Time frame: every two weeks until asymptotic performance is noted (up to 12 weeks)
Changes in how difficult it is to understand speech in background noise
2 secondary outcomes
Self-perceived hearing device benefit
Time frame: daily during field trial (up to 12 weeks)
Overall perceived benefit from hearing device
Time frame: every two weeks until asymptotic performance is noted (up to 12 weeks)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- 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 over-the-counter hearing device in people with Hearing Loss, Functional, run by University of Massachusetts, Amherst 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 3 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: withdrawn, as of the sponsor's last update on 20 Oct 2021. 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 was withdrawn before enrolling participants, so there are no results.
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 Perception (time frame: every two weeks until asymptotic performance is noted (up to 12 weeks)). The study lists 4 primary outcomes in all. 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 20 Oct 2021.